[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-adenocarcinoma":653},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,87,0,25,[9,48,72,96,145,170,190,217,239,254,291,309,336,358,381,406,434,458,478,498,527,552,577,605,627],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053859",false,"NCT07699939","Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma: A Randomized Phase 2 Investigator-Initiated Trial","PLATANUS","Inclusion Criteria:\n\n1. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma at the study site. (For gastroesophageal junction adenocarcinoma, only patients classified as Siewert type II or type III who do not require surgery involving simultaneous thoracoabdominal incision are eligible.)\n2. Tumor tissue determined to be PD-L1 positive (CPS \\>= 5) based on pre-screening evaluation by the central laboratory. 3) Diagnosis of cT3-4N1-3M0 disease according to the AJCC\u002FUICC-TNM 8th edition based on assessments performed within 28 days prior to randomization (the same day of the week 4 weeks before the randomization date is acceptable; the same applies hereafter), with no prior systemic treatment. Pre-randomization laparoscopy is not mandatory, but if performed, no non-curative factors (including liver metastasis, peritoneal metastasis, other distant metastases, or positive peritoneal cytology (CY1)) should be observed.\n\n4\\) Judged by the investigator as capable of undergoing R0 resection. 5) Age between 18 years and 80 years on the day of enrollment. 6) ECOG performance status (PS) of 0 or 1. 7) The most recent laboratory values obtained within 14 days prior to randomization meet all of the following (however, transfusion, recombinant human thrombopoietin, and administration of granulocyte colony-stimulating factor (G-CSF) within 14 days prior to blood collection are not permitted): (1) Neutrophil count \\>= 1500\u002Fmm\\^3 (2) Hemoglobin \\>= 9.0 g\u002FdL (3) Platelet count \\>= 10 x 10\\^4\u002Fmm\\^3 (4) Total bilirubin \\\u003C= 1.5 mg\u002FdL (5) AST \\\u003C= 100 U\u002FL (6) ALT \\\u003C= 100 U\u002FL (7) Serum albumin \\>= 3.0 g\u002FdL (8) Serum creatinine \\\u003C= 1.5 mg\u002FdL (9) APTT \\\u003C= 60 s (10) PT-INR \\\u003C= 1.5 8) Females of childbearing potential should test negative for pregnancy test (serum or urine) within 7 days prior to randomization (the same day of the week is acceptable).\n\n9\\) Male patients and females of childbearing potential agree to use contraception from the time of provision of informed consent through a specified period after the last administration of study treatment (until at least 120 days after the last dose of HLX10 and at least 180 days after the last dose of study drug other than HLX10 (S-1 or oxaliplatin)).\n\n10\\) Written informed consent for study participation has been obtained from the patient.\n\nExclusion Criteria:\n\n1. Presence of another active malignancy within 5 years prior to enrollment or concurrently. Patients with cured, localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, non-invasive prostate cancer, non-invasive cervical cancer, and non-invasive breast cancer are permitted.\n2. Patients scheduled to undergo organ transplantation or bone marrow transplantation.\n3. Myocardial infarction and\u002For uncontrolled arrhythmia (including QTc interval \\>= 450 ms in males or \\>= 470 ms in females) occurring within 6 months prior to randomization (QTc interval calculated using Fridericia's formula).\n4. Cardiac dysfunction classified as NYHA Class III-IV, or left ventricular ejection fraction (LVEF) \\\u003C 50 percent on echocardiography.\n5. Positive for any of the following: HIV antibody, HBs antigen, or HCV-RNA (HCV-RNA is measured only if HCV antibody is positive).\n6. HBs antigen negative, HBs antibody and\u002For HBc antibody positive, and quantitative HBV-DNA detectable (patients are not excluded if HBV-DNA is below the limit of detection).\n7. Active tuberculosis.\n8. Interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and\u002For severe pulmonary dysfunction that may interfere with evaluation and management of suspected drug-related pulmonary toxicity.\n9. Known active or suspected autoimmune disease, excluding patients whose disease is stable at randomization and who do not require systemic immunosuppressive therapy.\n10. Patients who received live vaccination within 28 days prior to randomization, except for inactivated virus vaccines used for seasonal influenza prophylaxis.\n11. Patients who require systemic corticosteroids (a therapeutic dose of \\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to randomization or during the study period. However, in the absence of active autoimmune disease, patients are permitted to use steroids at a dose of \\\u003C= 10 mg\u002Fday prednisone or equivalent, or inhaled steroids, or adrenal hormone replacement therapy.\n12. Patients who have an active infection requiring systemic anti-infective treatment within 14 days prior to randomization, except for prophylactic antibiotic treatment (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease).\n13. Prior treatment with other antibody or drug therapies for immune checkpoint blockade, such as PD-1, PD-L1, or CTLA-4 therapy.\n14. Patients currently receiving other clinical study treatment, or for whom the planned start of treatment in this study is \\\u003C 14 days from completion of the prior clinical study treatment.\n15. History of severe hypersensitivity to the monoclonal antibody or any component of the study drug.\n16. History of psychotropic drug abuse or drug dependence.\n17. Patients with a disease that may increase the risk associated with study participation and use of the study drug, or with other severe acute or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the study.","ALL","18 Years","80 Years",{"count":20,"type":21},136,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the clinical efficacy of perioperative treatment with S-1 + oxaliplatin (SOX)+ HLX10 compared with SOX as the control in patients with cT3-4N1-3M0 PD-L1-positive (CPS ≥ 5) locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, in a placebo-controlled, double-blind, randomized phase II investigator-initiated clinical study.",[27,28],"Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma",[30,31,32,33,34],"SOX regimen","PD-1 inhibitor","Perioperative chemotherapy","serplulimab","Immuno-chemotherapy","NOT_YET_RECRUITING","2026-07-07",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07-15",{"date":43,"type":21},"2029-06-30",{"name":45,"class":46},"National Cancer Center, Japan","OTHER_GOV",18,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100638663","NCT07584135","JS107 in Combination With Toripalimab and Chemotherapy for the Treatment of CLDN18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma","A Multicenter, Randomized, Controlled, Open-label Phase III Clinical Trial Evaluating the Efficacy and Safety of JS107 in Combination With Toripalimab and Chemotherapy Versus Sintilimab in Combination With Chemotherapy as First-line Treatment for CLDN18.2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria\n\n1. The patient voluntarily participated, provided informed consent, signed a written informed consent form, and had good compliance.\n2. Age ≥18 years (including), male and female. 3)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4）Expected survival period ≥3 months.\n\n5）Patients with HER2-negative, unresectable locally advanced, recurrent, or Metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histology\u002Fcytology. 6）Previously untreated for systemic therapy for locally advanced, recurrent, or Metastatic gastric\u002Fgastroesophageal junction (G\u002FGEJ) adenocarcinoma. 7）Positive for CLDN18.2 by IHC testing at the central laboratory. 8）According to the RECIST v1.1 criteria, the patient has ≥1 measurable lesion. 9）The functional level of the organ meets the requirements of the protocol. 10）Agree to use contraception during the study period; females of reproductive potential will undergo a blood pregnancy test within 7 days prior to randomization, with a negative result.\n\nExclusion Criteria:\n\n1. Previously received any drug or cell therapy targeting CLDN18.2\n2. Received major surgery, live vaccine administration, or Drug therapy with other investigational medicinal products, or received radiotherapy within 2 weeks prior to randomization.\n3. Imaging shows cerebral tumor lesions (unless whole-brain radiotherapy or surgery, etc., local treatment has been completed, and imaging and clinical stability have been assessed according to the protocol) 4)Peripheral neuropathy ≥ Grade 2\n\n5）Idiopathic pulmonary fibrosis, Organising pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest computerised tomography (CT) scan 6）Pericardial effusion, Pleural effusion, or ascites with a large volume, or with clinical symptoms, or requiring symptomatic treatment.\n\n7）There is a need for systemic antimicrobial or antiviral therapy for active infection.\n\n8）Subjects who cannot take oral medications, require enteral nutrition to maintain feeding, or have Malabsorption syndrome or other conditions affecting gastrointestinal Malabsorption.\n\n9）Presence of biliary or gastrointestinal obstruction, or persistent recurrent vomiting 10）Weight loss of \\>10% within the previous 2 months or severe Malnutrition, known prior to randomization.\n\n11）History of gastrointestinal perforation and\u002For fistula within the prior 6 months; presence of high-risk Haemorrhage of digestive tract disease or risk of rupture bleeding or gastrointestinal\u002Frespiratory fistula 12）Serious cardiovascular and cerebrovascular diseases 13）History of systemic treatment for autoimmune diseases within the past 2 years 14）Randomly selected patients with any other Neoplasm malignant within the past 5 years.\n\n15）Known severe allergic reaction to any ingredient in the study drug formulation 16）Known active Hepatitis B, active Hepatitis C, human immunodeficiency (HIV) infection, or have undergone allogeneic stem cell or Solid organ transplant.\n\n17）Diseases determined by researchers to be unsuitable for participation.",{"count":55,"type":21},600,[57],"PHASE3","This study is a multicenter, randomized, open-label, controlled Phase III clinical trial aimed at evaluating the efficacy and safety of JS107 combined with toripalimab XELOX versus sintilimab combined with XELOX as first-line treatment for patients with advanced G\u002FGEJ adenocarcinoma.\n\nThe research subjects were patients with unresectable locally advanced, recurrent or metastatic G\u002FGEJ adenocarcinoma who were CLDN18.2-positive and HER2-negative and had not received systemic treatment before (except for neoadjuvant\u002Fadjuvant therapy that occurred more than 6 months after disease progression\u002Frecurrence from the last treatment). The study took BICR-PFS and OS as Dual primary endpoints.",[27],"RECRUITING","2026-06-25",{"date":63,"type":39},"2026-06-29",{"date":65,"type":39},"2026-05-28",{"date":67,"type":21},"2029-12-31",{"name":69,"class":70},"NingBo Junyan Hongshi Biosciences Co., Ltd","INDUSTRY",1,{"id":73,"slug":4,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100644673","NCT07673887","A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer","A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive","Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed gastric or GEJ adenocarcinoma.\n* Participant has radiographically confirmed, locally advanced unresectable or metastatic disease within 28 days prior to randomization.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a women of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum human chorionic gonadotropin (HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after the final administration of study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final administration of study intervention.\n* Male participant must not donate sperm during the treatment period and for 6 months after the final administration of study intervention.\n* Participant has radiologically evaluable disease (measurable and\u002For non measurable) according to RECIST V1.1, per investigator assessment, \\\u003C= 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy \\\u003C= 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\n* Participant's tumor is HER2-negative (HER2 immunohistochemistry (IHC) score 0+\u002F1+ or HER2 IHC score 2+\u002Fin situ hybridization (ISH) negative) as determined by local or central testing.\n* Participant has provided an formalin-fixed paraffin-embedded (FFPE) tumor sample which meets the requirements of the study as specified in the laboratory manual.\n* Participant has CLDN18.2-positive tumor as determined by central testing.\n* Participant has a valid programmed death-ligand 1 (PD-L1) result as determined by central testing of a tumor sample.\n* Participant with known microsatellite instability-high or mismatch repair deficient status may enroll as long as their tumor expresses PD-L1 combined positive score (CPS) \\>= 1 as determined by central IHC testing.\n* Participant has ECOG performance status 0 to 1.\n* Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used (transfusion is allowed, but posttransfusion hemoglobin \\[24 hours or later following transfusion\\] must be \\>= 9 g\u002FdL).\n\nSouth Korea Specific:\n\n* Participant is \\>= 19 years of age at the time of signing informed consent.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must not donate sperm during the treatment period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n\nJapan Specific:\n\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG and a demonstrated nonpregnant status through additional testing are eligible.)\n\nExclusion Criteria:\n\n* Participant has mixed histology or non-adenocarcinoma gastric or GEJ cancer.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to randomization.\n* Participant has gastrointestinal (GI) perforation, fistulae, untreated gastric ulcers that would preclude the participant from study participation, or any arterial thromboembolic event within 6 months, or any significant GI bleeding or any significant venous thromboembolism within 3 months prior to randomization.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has pre existing peripheral neuropathy \\> Grade 1.\n* Participant has poorly controlled hypertension.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.\n  * corrected QT (QTc) interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants.\n  * Documented history or family history of congenital long QT syndrome.\n  * Cardiac arrhythmias requiring anti-arrhythmic medications (Exception: Participant with rate-controlled atrial fibrillation for \\> 1 month prior to randomization is eligible), obligate use of cardiac pacemaker, or a history of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes).\n* Participant has a diagnosis of immunodeficiency or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Participants that require replacement therapy (e.g., thyroxine (T4), insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has history of another malignancy within 3 years prior to randomization, or any evidence of residual disease from a previously diagnosed malignancy. Participants with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance\u002Fwatchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with medications that affect the coagulation cascade with an international normalized ratio (INR) \\> 2 (e.g., vitamin K antagonists) is not allowed.\n* Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade \\>= 2 bleeding events 28 days prior to randomization).\n* Participant has uncontrolled intercurrent illness.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.\n* Participant is known to have human immunodeficiency virus (HIV) infection except for those with cluster of differentiation (CD) 4+ T cell counts \\>= 350 cells\u002Fmicroliter (µL) and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months are eligible. NOTE: Screening for HIV infection should be conducted if indicated per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted if indicated per local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core (HBc) antibody positive, an hepatitis B virus (HBV) DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of a positive test for tuberculosis or known active tuberculosis infection. NOTE: Screening for these infections should be conducted per local requirements.\n* Participant has known complete dihydropyrimidine dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).\n* Participant has pernicious anemia or other anemias due to vitamin B12 deficiency.\n* Participant has received prior systemic chemotherapy and\u002For immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, a maximum of 1 cycle of mFOLFOX6 or CAPOX with or without immunotherapy (for those participants with CPS \\>= 1) is allowed to be administered prior to randomization (Note: No dose modifications are allowed for the lead-in treatment). Participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy, or other systemic anticancer therapies as long as they were completed at least 6 months prior to randomization and there was disease progression occurs at least 6 months after the last dose. Participant may have received treatment with herbal medications that have known antitumor activity \\> 28 days prior to randomization. NOTE: Participants must have recovered from all AEs due to previous therapies to \\\u003C= Grade 1 or baseline.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids \\\u003C= 7 days prior to randomization. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.\n* Participant has had a major surgical procedure \\\u003C= 28 days before randomization and has not fully recovered.\n* Participant has received a CLDN18.2-targeted therapy \\\u003C= 28 days or 5 half-lives (whichever is longer) prior to randomization, or participant has experienced Grade \\>= 3 GI toxicity after receiving a CLDN18.2-targeted therapy.\n* Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma \\\u003C= 14 days prior to randomization and has NOT recovered from any related toxicity. A 7-day washout is permitted for palliative radiation (\\\u003C= 14 days duration time for radiotherapy) to non-CNS disease.\n* Participant has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\], OX-40, CD137) unless received in the perioperative setting.\n* Participant received a live or live-attenuated vaccine within 30 days prior to randomization. NOTE: Inactivated seasonal influenza vaccines are allowed.\n* Participant has received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to randomization or within 5 half-lives of the drug, whichever is shorter.\n* Participant has received any investigational therapy within 28 days prior to randomization or within 5 half-lives of the investigational medicinal product (IMP), whichever is longer.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n\nEU Specific:\n\n* Participant has known complete DPD deficiency (screening for DPD deficiency should be conducted per local requirements). All participants in the EU must be tested for DPD deficiency before receiving fluoropyrimidine-based chemotherapy, in accordance with European Society for Medical Oncology and European Medicines Agency (EMA) recommendations.",{"count":79,"type":21},570,[57],"Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system. It is also found in some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a type of immune cell called a T cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with gastric cancer (also known as stomach cancer) or gastroesophageal junction cancer (GEJ cancer). GEJ is where the tube that carries food (esophagus) joins the stomach.\n\nThis study is for people with gastric or GEJ cancer that has spread nearby (locally advanced) and is not removable by surgery (unresectable), or has spread to other parts of the body (metastatic). It is for those whose cancer is human epidermal growth factor receptor 2 (HER2)-negative and CLDN18.2-positive. HER2-negative means the cancer does not have extra HER2 protein, so medicines that target HER2 do not work and are therefore not used. CLDN18.2-positive means people have a certain amount of CLDN18.2 proteins on their cancer cells. In this study, researchers want to learn if ASP2138 given together with standard treatments (chemotherapy and pembrolizumab) help people with HER2-negative and CLDN18.2-positive gastric or GEJ cancer. The main aim is to learn how long people who are given ASP2138 with chemotherapy and pembrolizumab live without their cancer getting worse, compared with placebo given with chemotherapy with or without pembrolizumab, and if they live for longer. Placebo looks like the study treatment but does not have any medicine in it.\n\nThe main aim of this study is to check how well ASP2138 works when given together with chemotherapy and pembrolizumab compared with placebo plus chemotherapy with or without pembrolizumab.\n\nPeople aged 18 years or older with locally advanced unresectable or metastatic gastric or GEJ cancer can take part. Their tumor should be HER2-negative and CLDN18.2-positive. The study doctors will check people for any health conditions that can exclude them from taking part, interfere with the study procedures, or pose an unacceptable risk.\n\nThis is a double-blind study. That means the people and the study doctors will not know who will receive which treatment. People will be assigned to one of 2 treatment groups by chance:\n\nGroup A: People will receive ASP2138 along with chemotherapy and pembrolizumab. Group B: People will receive placebo along with chemotherapy, with or without pembrolizumab.\n\nPeople will keep receiving treatment until their cancer gets worse, they have medical problems that require stopping treatment, or a study rule says they must stop. There will be regular safety checks. People will continue to have scans of their tumor until their cancer becomes worse.",[27,28],[84,85,86,87],"Claudin (CLDN) 18.2","ASP2138","Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","2026-06-23",{"date":63,"type":39},{"date":91,"type":21},"2026-06-30",{"date":93,"type":21},"2031-02-28",{"name":95,"class":70},"Astellas Pharma Global Development, Inc.",{"id":97,"slug":4,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":120,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100614270","NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease",{"count":103,"type":21},260,[105],"PHASE1","This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[108,109,27,110,111,112,113,114,115,116,117,118,119],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Bladder Cancer","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[121,122,123,124,125,126,127,128,129,130,131,132,133,134,135],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","2026-06-19",{"date":88,"type":39},{"date":139,"type":39},"2026-03-04",{"date":141,"type":21},"2028-04-30",{"name":143,"class":70},"IDEAYA Biosciences",14,{"id":146,"slug":4,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":167,"locationsCount":169},"100519056","NCT06038578","A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.\n* The patient is eligible to receive Ramucirumab + Paclitaxel.\n* Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and\u002For cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:\n\n  1. First treatment for metastatic disease or locally advanced disease without experiencing adjuvant \u002F neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment\n  2. Adjuvant \u002F neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment\n  3. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment\n  4. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment\n* Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.\n* Signed, written IRB-approved informed consent.\n* Adequate organ function from specimens collected within 14 days prior to Day 1.\n* For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.\n* All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.\n\nExclusion Criteria:\n\n* Prior history of treatment with ramucirumab or paclitaxel.\n* HER2 positive gastric or GEJ adenocarcinoma.\n* Major surgery within 28 days prior to randomization.\n* Baseline corrected QT (QTc) interval of \\> 470 msec for females and \\> 450 msec for males calculated using Fridericia's formula.\n* New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.\n* The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.\n* The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)\n* Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).\n* The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.\n* Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.\n* History of gastrointestinal perforation and\u002For fistulae within 6 months prior to randomization.\n* The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.\n* The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.\n* The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.",{"count":152,"type":21},146,[24],"This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.",[27,156,157],"Gastric Cancer","Gastroesophageal Junction Adenocarcinoma",[159,157,160,161],"Gastric Cancer, Adenocarcinoma","TRK-950","CAPRIN-1","2026-06-18",{"date":88,"type":39},{"date":165,"type":39},"2023-10-04",{"date":91,"type":21},{"name":168,"class":70},"Toray Industries, Inc",27,{"id":171,"slug":4,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":71},"100374067","NCT04150640","Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma","Phase 2 Trial of 5-Fluorouracil, Oxaliplatin and Liposomal Irinotecan and Immunotherapy (Plus Trastuzumab for HER2-positive Disease) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information.\n\nNOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS status prior to treatment initiation.\n* Measurable disease according to RECIST v1.1.\n* No prior lines of systemic therapy for advanced disease.\n* Participants who had received neoadjuvant or adjuvant therapy or definitive chemoradiation will be allowed to participate if recurrence occurred 6 months or longer from the completion of all prior treatments.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to registration\n\n  * Absolute Neutrophil Count (ANC) ≥1,500 \u002Fμl without the use of hematopoietic growth factors\n  * Hemoglobin (Hgb) ≥8 g\u002FdL (blood transfusions are permitted for participants with hemoglobin levels below 8 g\u002FdL)\n  * Platelets ≥100,000 \u002Fμl\n  * Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl calculation using the Cockcroft-Gault formula. ≥50 mL\u002Fmin for participants with creatinine levels \\> 1.5 X institutional ULN\n  * Bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); abnormal bilirubin (≤1·5 × upper limit of normal (ULN)) is allowed for patients with Gilbert's disease\n  * Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Women of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n* Women of childbearing potential and males must be willing to abstain from heterosexual activity or to use a form of effective method of contraception from the time of informed consent until 30 days after treatment discontinuation.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products.\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrollment).\n* Other active malignancy requiring treatment within the last 2 years. Exceptions include subjects with non-melanoma skin cancer, non-invasive\u002Fin situ cancer or low-risk prostate cancer requiring hormonal therapy only.\n* Current therapy with other investigational agents or participation in another clinical study (supportive care and nontherapeutic trial participation allowed if not receiving an investigational drug). Participants may participate in prescreening for other therapeutic trials (prescreening of biologic sample for specific mutations, receptors, etc.)\n* Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement).\n* Radiotherapy less than 7 days prior to the start of the study treatment\n* Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should not have any contraindications to immune checkpoint inhibitors and should not have received immunotherapy agents for the treatment of EGA prior to study enrollment.\n\n  * Participants must not have active autoimmune disease that has required systemic treatment in the past 2 years. Participants are permitted to receive immunotherapy l if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).\n  * Participants must not have a condition requiring systemic treatment with either corticosteroids (\\>10 mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of study immunotherapy administration. Inhaled or topical steroids and adrenal replacement doses (≤10 mg\u002Fday prednisone equivalent) are permitted. Participants with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents.\n* Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Active infection requiring systemic therapy.\n* Pregnant or breastfeeding.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.\n* Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.\n* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.\n* Known history of Human Immunodeficiency Virus (HIV).",{"count":177,"type":21},52,[24],"This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.",[181,27],"Esophageal Adenocarcinoma",{"date":88,"type":39},{"date":184,"type":39},"2020-07-13",{"date":186,"type":21},"2028-05",{"name":188,"class":189},"University of Wisconsin, Madison","OTHER",{"id":191,"slug":4,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":207,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":71},"100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":197,"type":21},72,[24],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[201,202,203,204,27,205,181,206],"Melanoma","NSCLC","Hepatocellular Carcinoma","Urothelial Cancer","HNSCC","Microsatellite Instability-High Solid Malignant Tumor",[208,209],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)",{"date":88,"type":39},{"date":212,"type":39},"2020-09-14",{"date":214,"type":21},"2032-04-30",{"name":216,"class":189},"Dan Zandberg",{"id":218,"slug":4,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":225,"studyType":226,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100644416","NCT07662070","Emotional Distress and Pathologic Response in Locally Advanced Gastric\u002FGEJ Adenocarcinoma","A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Willing to participate in this study.\n2. Age \\>18 years; both sexes are eligible.\n3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n4. Resectable locally advanced disease as assessed by imaging and\u002For multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.\n5. Planned to receive neoadjuvant therapy followed by curative-intent surgery.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. No prior systemic antitumor treatment for the current tumor at baseline.\n8. Able to understand and complete questionnaire assessments.\n9. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.\n4. Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.\n5. Any other condition judged by the investigator to make the participant unsuitable for enrollment.",{"count":224,"type":21},120,"3 Years","OBSERVATIONAL","This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.",[27,157,229,230],"Emotional Distress","Pathologic Response","2026-06-17",{"date":88,"type":39},{"date":234,"type":21},"2026-06-26",{"date":236,"type":21},"2028-12-31",{"name":238,"class":189},"West China Second University Hospital",{"id":240,"slug":4,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":245,"targetDuration":225,"studyType":226,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":253,"locationsCount":4},"100644388","NCT07662005","Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric\u002FGEJ Cancer","Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Prospective Observational Study","Inclusion Criteria:\n\n1. Age greater than 18 years, regardless of sex.\n2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.\n4. Scheduled to receive neoadjuvant therapy followed by radical surgery.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n6. No prior systemic anticancer therapy for the current tumor at study baseline.\n7. Willing to participate in the study and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.\n4. Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:\n\n   1. Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;\n   2. Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;\n   3. Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;\n   4. Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.\n5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.",{"count":224,"type":21},"This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.",[27,157,248,249],"Sleep","Pathological Response",{"date":88,"type":39},{"date":234,"type":21},{"date":236,"type":21},{"name":238,"class":189},{"id":255,"slug":4,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":273,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":71},"100614693","NCT07282912","Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","OLIGOMETS","Inclusion Criteria:\n\n* Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.\n\n  a) All participants must have confirmed histologic diagnosis of the primary tumor, which may be confirmed retrospectively by a radiologist if necessary.\n* Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo\u002Fradioembolization (cholangiocarcinomas).\n* Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:\n\n  1. Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative radiation\u002Fablative therapy\n  2. Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments), wedge resection requiring a minimum of 40% of liver parenchyma following resection based on future liver remnant or a combination of partial hepatectomy and microwave ablation or trans-arterial radioembolization (TARE).\n  3. Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites) (see Appendix 3).\n  4. Resectable peritoneal disease with a PCI of ≤6 and the ability to obtain a CC0 cytoreduction.\n  5. Distant metastasis must be limited to two of the above-mentioned sites (a-d).\n  6. If both pulmonary and liver metastasis are present (a, b), then a total of five lesions will be considered oligometastatic.\n* Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.\n* Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.\n* Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.\n* Patients must have at least 4 months of prior effective systemic therapy.\n* Has hemoglobin ≥ 8 g\u002FdL.\n* Has ANC ≥ 1500\u002FuL.\n* Has platelet count ≥ 75000\u002FuL.\n* Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n* Has aspartate aminotransferase (AST) \\& alanine aminotransferase (ALT) ≤ 5 times ULN.\n* Has creatinine clearance ≥ 50 mL\u002Fmin.\n* Patient who is at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score 0-1 (see Appendix 6) at the time of randomization.\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence) during the treatment period and for at least 95 days following completion. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the participant may participate in the main study without participating in the FBR.\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nNote: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* Has developed progressive disease on current line of systemic therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past three years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known CNS metastasis and\u002For carcinomatous meningitis.\n* Has known osseous metastasis.\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.\n* Has histologic subtypes not included in the inclusion criteria (including esophageal squamous cell carcinoma, gastroenteropancreatic neuroendocrine tumors, hepatocellular carcinoma, etc.).\n* Has a primary tumor that is not amenable to the treatment modalities listed in section 3.\n* Has albumin level less than 3.0 g\u002FdL despite appropriate nutritional support. Diagnostic Assessments\n* Has detectable ctDNA at the time of enrollment.\n* Has an active infection requiring systemic therapy.\n* Has known active TB\u002FCOVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.\n* Inability to receive chemotherapy and\u002For surgery and\u002For radiotherapy and\u002For ablative procedures due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.",{"count":262,"type":21},54,[24],"This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.",[266,181,267,27,268,269,270,271,272],"Foregut Adenocarcinoma","Gastroesophageal Adenocarcinoma","Pancreas Adenocarcinoma","Duodenal Adenocarcinoma","Ampullary Adenocarcinoma","Gallbladder Adenocarcinoma","Intra - and Extrahepatic Cholangiocarcinoma",[274,275,276,277,278,279,280,281,282],"Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Oligometastasis","Esophageal adenocarcinoma","Gastroesophageal adenocarcinoma,","Gastric adenocarcinoma","Duodenal adenocarcinoma","Pancreatic\u002Fampullary adenocarcinoma","Gallbladder adenocarcinoma","Intra- and extrahepatic cholangiocarcinoma.",{"date":284,"type":39},"2026-06-22",{"date":286,"type":39},"2026-06-02",{"date":288,"type":21},"2028-06",{"name":290,"class":189},"Yale University",{"id":292,"slug":4,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":71},"100641343","NCT07581405","GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2\n* Histologically confirmed gastric adenocarcinoma, documented by biopsy.\n* Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.\n* Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy\n* Uncontrolled HIV\u002FAIDS or active viral hepatitis\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Patients with a feeding tube (e.g., gastrostomy or jejunostomy) receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment.\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.\n* Other major comorbidity, as determined by the study PI",{"count":297,"type":21},26,[24],"This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.",[27,156],"2026-06-16",{"date":162,"type":39},{"date":304,"type":21},"2026-07",{"date":306,"type":21},"2030-07",{"name":308,"class":189},"University of Illinois at Chicago",{"id":310,"slug":4,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":335},"100593077","NCT07001748","Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity","Protocol EA2234: A Randomized Phase II\u002FIII Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II","STOPGAP II","STEP 0 REGISTRATION:\n\n* Patient must be at least 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H\u002FdMMR) mismatch repair deficient disease are not eligible\n* Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment\n* Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy\n* Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy\n* Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration\n* Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy\n* Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy\n* Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement\n* Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin\n* Leukocytes ≥ 2,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (≤ 30 days prior to Step 0 registration)\n* Platelets ≥ 75,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \\\u003C 2.0 mg\u002FdL (≤ 30 days prior to Step 0 registration)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration)\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)\n* Hemoglobin ≥ 8 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Serum albumin ≥ 2.5 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n\nSTEP 1 RANDOMIZATION:\n\n* Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained\n* The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available\n* Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port",{"count":317,"type":21},148,[24,57],"This study is being done to answer the following questions:\n\nCan we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer.\n\nIf you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below.\n\nIf you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen).\n\nIf you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment.\n\nIt is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in.\n\nOnce you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon.\n\nThere is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called \"intra-abdominal adhesions\". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help.\n\nAfter you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest\u002FAbdomen\u002FPelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.",[27,157,321],"Peritoneal Carcinomatosis",[323,324,314,325,326],"EA2234","Intraperitoneal Paclitaxel","STOPGAP I","Gastric Carcinomatosis",{"date":231,"type":39},{"date":329,"type":39},"2025-08-19",{"date":331,"type":21},"2030-05-30",{"name":333,"class":334},"ECOG-ACRIN Cancer Research Group","NETWORK",55,{"id":337,"slug":4,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":354,"leadSponsor":356,"locationsCount":4},"100641511","NCT07658872","Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma","Perioperative Fruquintinib Combined With Sintilimab and SOX Versus Sintilimab and SOX for Resectable Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma：A Multicenter,Open-label, Randomized Controlled Phase II Clinical Study","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Histologically confirmed gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Clinically staged as T3-4a N0-3M0 by computed tomography (CT) or magnetic resonance imaging (MRI).\n5. Considered eligible for curative resection.\n6. No prior antitumor therapy for the current disease.\n7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.\n8. Expected survival of ≥6 months.\n\nExclusion Criteria:\n\n1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.\n2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.\n3. Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.\n4. History of thromboembolic or arterial\u002Fvenous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.\n5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.","75 Years",{"count":224,"type":21},[24],"The purpose of this clinical trial is to evaluate whether perioperative fruquintinib combined with sintilimab and SOX is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.\n\nPrimary Objective:\n\nTo determine whether perioperative fruquintinib combined with sintilimab and SOX improves the pathological complete response (pCR) rate compared with sintilimab plus SOX in patients with locally advanced gastric or GEJ adenocarcinoma.\n\nStudy Design:\n\nParticipants will be randomly assigned to receive either fruquintinib combined with sintilimab and SOX or sintilimab plus SOX to evaluate the potential added benefit of fruquintinib in this setting.\n\nParticipation Details:\n\nParticipants will receive the assigned treatment (fruquintinib combined with sintilimab and SOX or sintilimab plus SOX) every 21 days for approximately 3 months.\n\nThey will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.\n\nParticipants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.",[27,347],"Esophagogastric Junction Adenocarcinoma",[156,349,350],"neoadjuvant treatment","Fruquintinib","2026-06-15",{"date":284,"type":39},{"date":351,"type":21},{"date":355,"type":21},"2028-04-06",{"name":357,"class":189},"Sichuan University",{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":4},"100641601","NCT07621484","HIPEC Priming Followed by Serplulimab Plus SOX\u002FXELOX in Locally Advanced Gastric Cancer","A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX\u002FXELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive); gender unrestricted.\n* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma via endoscopic biopsy.\n* Clinical stage cT3-4a (imaging evidence of tumor invasion into or penetration through the serosa), any N (lymph node positive), M0 (no distant organ metastasis), based on the 8th Edition of the AJCC Staging Manual.\n* HER2-negative disease, defined as HER2 IHC 0 or 1+, or IHC 2+ with negative ISH.\n* Diagnostic laparoscopy confirms the absence of macroscopic peritoneal metastasis (P0) and negative peritoneal lavage cytology (CY0).\n* Adequate cardiac function, rendering the patient eligible for curative-intent resection. If clinically indicated, patients with underlying ischemic heart disease, valvular heart disease, or other severe cardiac conditions must undergo a preoperative cardiac evaluation by a cardiologist.\n* ECOG Performance Status (PS) score of 0 or 1 within 7 days prior to enrollment.\n* Anticipated survival time of ≥ 6 months.\n* Hepatitis B surface antigen (HBsAg) negative (-) and Hepatitis B core antibody (HBcAb) negative (-). If HBsAg is positive (+) or HBcAb is positive (+), the Hepatitis B virus DNA (HBV-DNA) level must be \\\u003C 1000 copies\u002FmL, \\\u003C 200 IU\u002FmL, or below the upper limit of normal (ULN) at the study center to be eligible for enrollment.\n* HCV antibody negative (-).\n* Major organ function is normal, defined as meeting the following criteria (having not received transfusions of blood products, albumin, recombinant human thrombopoietin, or colony-stimulating factors \\[CSF\\] within 14 days prior to randomization):\n\nHematologic System Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL Platelets (PLT) ≥ 100×10⁹\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Liver Function Total Bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Aspartate Aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Alkaline Phosphatase (ALP) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver and\u002For bone metastases Albumin ≥ 25 g\u002FL Renal Function Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) Coagulation Function Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN Prothrombin Time (PT) ≤ 1.5×ULN International Normalized Ratio (INR) ≤ 1.5×ULN -Female patients must meet the following criteria:\n\nBe in a postmenopausal state (defined as having had no menstruation for at least 1 year, with no other confirmed cause for amenorrhea other than menopause), or have undergone surgical sterilization (removal of ovaries and\u002For uterus); alternatively, patients with reproductive potential must simultaneously meet the following requirements:\n\n* A serum pregnancy test result must be negative within 7 days prior to randomization;\n* Agree to use a contraceptive method with an annual failure rate of \\\u003C 1% or practice abstinence (avoidance of heterosexual intercourse) (from the time of signing the informed consent form until at least 120 days after the last dose of the investigational drug, and at least 6 \\[months\\] after the last dose of the chemotherapy drug ...months (contraceptive methods with an annual failure rate of \\\u003C 1% include bilateral tubal ligation, vasectomy, correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices \\[IUDs\\], and copper-containing IUDs);\n* Must not be breastfeeding. -Male patients must meet the following criteria: Agree to practice abstinence (avoid heterosexual intercourse) or use contraception, as specified below: If the partner is a female of childbearing potential or is pregnant, the male patient must practice abstinence or correctly use condoms for contraception-to prevent drug exposure to the embryo-during the chemotherapy treatment period and for at least 6 months after the last dose of chemotherapy medication, and for at least 120 days after the last dose of the investigational drug. The reliability of sexual abstinence should be evaluated with reference to the duration of the clinical study, patient preference, and lifestyle. Periodic abstinence (e.g., calendar-based, ovulation-based, basal body temperature, or post-ovulation methods) and withdrawal (coitus interruptus) are not considered acceptable methods of contraception.\n\nExclusion Criteria:\n\n* History of other active malignancies within the past 5 years, or the presence of other active malignancies at the time of enrollment. Patients with cured localized tumors-such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, or carcinoma in situ of the breast-are eligible for enrollment.\n* Presence of documented distant metastases (e.g., liver, lung, or bone metastases) or laparoscopically confirmed peritoneal seeding (P1).\n* Patients scheduled to undergo, or with a history of having undergone, organ or bone marrow transplantation.\n* Occurrence of myocardial infarction or poorly controlled arrhythmias (including a QTc interval ≥ 450 ms for males or ≥ 470 ms for females; QTc interval calculated using the Fridericia formula) within 6 months prior to enrollment.\n* Presence of NYHA Class III or IV heart failure, or a cardiac ultrasound result showing a Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%.\n* Human Immunodeficiency Virus (HIV) infection.\n* Presence of active pulmonary tuberculosis.\n* History of, or current presence of, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe impairment of pulmonary function that could interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Presence of a known active or suspected autoimmune disease. Exceptions are made for patients whose disease is in a stable state at the time of enrollment (defined as requiring no systemic immunosuppressive therapy).\n* Receipt of a live vaccine within 28 days prior to enrollment; inactivated viral vaccines for seasonal influenza are permitted.\n* Patients requiring systemic corticosteroid therapy (at a prednisone-equivalent dose \\> 10 mg\u002Fday) or other immunosuppressive medications within 14 days prior to enrollment or during the study period. However, the following exceptions are permitted: in the absence of active autoimmune disease, patients may use topical or inhaled corticosteroids, or receive adrenal replacement therapy at a prednisone-equivalent dose ≤ 10 mg\u002Fday.\n* Presence of any active infection requiring systemic anti-infective treatment within 14 days prior to enrollment; prophylactic antibiotic treatment (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease) is an exception.\n* Prior receipt of any anti-tumor therapy for the current gastric cancer, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.\n* Currently receiving treatment in another clinical study, or the planned start date of the treatment in this study is less than 14 days after the completion of treatment in a previous clinical study.\n* Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug.\n* Known history of substance abuse (including drug abuse); patients who have ceased alcohol consumption are eligible for enrollment.\n* Presence of any condition that may increase the risks associated with study participation or the investigational drug, or presence of other severe, acute, or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the clinical study.",{"count":365,"type":21},48,[24],"Patients with locally advanced gastric cancer (LAGC), particularly those with serosal invasion, remain at high risk of peritoneal recurrence despite standard perioperative treatment. Hyperthermic intraperitoneal chemotherapy (HIPEC) may eradicate free intraperitoneal tumor cells and microscopic peritoneal disease while potentially enhancing systemic anti-tumor immune activation.\n\nThis is a prospective, single-center, single-arm exploratory study evaluating a HIPEC priming strategy followed by serplulimab-based neoadjuvant therapy in patients with locally advanced gastric cancer (cT3-4aN+M0). Eligible patients will undergo diagnostic laparoscopy confirming no visible peritoneal metastasis (P0) and negative peritoneal cytology (CY0), followed by docetaxel-based HIPEC.\n\nAfter recovery from HIPEC, patients will initially receive one cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX\u002FXELOX chemotherapy prior to radical gastrectomy.\n\nThe primary endpoints are pathological complete response (pCR) rate and major pathological response (MPR) rate. Secondary endpoints include R0 resection rate, objective response rate (ORR), peritoneal recurrence-free survival (PRFS), overall survival (OS), and safety.",[369,27,157],"Locally Advanced Gastric Cancer",[369,371,372,373],"HIPEC","Hyperthermic Intraperitoneal Chemotherapy","Peritoneal Recurrence",{"date":231,"type":39},{"date":376,"type":21},"2026-07-01",{"date":378,"type":21},"2028-05-09",{"name":380,"class":189},"Shanghai Changzheng Hospital",{"id":382,"slug":4,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":402,"leadSponsor":404,"locationsCount":71},"100641256","NCT07655661","Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.","A Multicenter, Single-Arm, Phase II Study of Mannatide Combined With CAPOX and Tislelizumab as First-Line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma.","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma.\n2. Unresectable recurrent or metastatic disease confirmed by imaging and surgical evaluation.\n3. Age 18 to 75 years.\n4. Expected survival greater than 3 months.\n5. No prior systemic therapy for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Previous neoadjuvant or adjuvant therapy is allowed if completed at least 6 months before enrollment without evidence of recurrence or progression.\n6. ECOG performance status 0-1.\n7. At least one measurable lesion according to RECIST version 1.1.\n8. Availability of tumor tissue for PD-L1 testing.\n9. Adequate hematologic, hepatic, renal, and coagulation function.\n10. Recovery of prior treatment-related toxicities to Grade 0-1 or baseline level.\n11. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n12. Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n1. HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n2. Squamous cell carcinoma, undifferentiated carcinoma, or mixed histology.\n3. Active or uncontrolled central nervous system metastases.\n4. Uncontrolled pleural effusion, ascites, or clinically significant pericardial effusion.\n5. Weight loss greater than 20% within 2 months before enrollment.\n6. Major surgery within 28 days before enrollment.\n7. Prior anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitor therapy.\n8. Active autoimmune disease requiring systemic treatment.\n9. Active hepatitis B, hepatitis C, or HIV infection.\n10. Interstitial lung disease or uncontrolled systemic disease.\n11. Significant cardiovascular disease within 6 months before enrollment.\n12. Known hypersensitivity to study drugs or their components.\n13. Participation in another interventional clinical trial within 4 weeks before enrollment.\n14. History of substance abuse or severe psychiatric disorder.\n15. History of rheumatic heart disease or known hypersensitivity to mannatide.\n16. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.",{"count":177,"type":21},[24],"This is a multicenter, open-label, single-arm phase II study evaluating the efficacy and safety of mannatide in combination with CAPOX chemotherapy and tislelizumab as first-line treatment for patients with recurrent or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n\nEligible patients will receive oxaliplatin, capecitabine, tislelizumab, and oral mannatide. Tumor response will be assessed according to RECIST version 1.1. Patients without disease progression after induction treatment may continue maintenance therapy with capecitabine, tislelizumab, and mannatide.\n\nThe primary objective is to evaluate objective response rate (ORR). Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory analyses will investigate immune microenvironment changes and potential predictive biomarkers using blood, tumor tissue, and stool samples.",[27,157],[392,393,394,156,395,396,397,398],"Mannatide","Tislelizumab","CAPOX","Gastroesophageal Junction Cancer","Metastatic Gastric Cancer","First-Line Treatment","Phase II Study","2026-06-13",{"date":162,"type":39},{"date":376,"type":21},{"date":403,"type":21},"2029-07-01",{"name":405,"class":189},"Ming Liu",{"id":407,"slug":4,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":433},"100614791","NCT07284186","First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, relapsed\u002Frefractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies\n* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function\n* Measurable disease per RECIST 1.1\n* ECOG PS of 0 or 1\n\nKey Exclusion Criteria:\n\n* Germline SMARCA4 mutations\n* Known SMARCA2 mutation or loss of expression\n* Symptomatic CNS disease\n* Prior treatment with another SMARCA2-directed therapy\n* History of other malignancies\n* Clinically significant heart disease\n* Uncontrolled hypertension\n* Prolongation of QT interval",{"count":413,"type":21},155,[105],"A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed\u002Frefractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.\n\nThe study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.\n\nParticipants will receive their assigned dose of PLX-61639 administered orally, once daily until progression\u002Frelapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.",[417,27,418,28,419,420,181,421,422,423],"Esophageal Squamous Cell Carcinoma","Gastric Squamous Cell Carcinoma","Metastatic Solid Tumor","Non-Small Cell Lung Carcinoma","SMARCA4 Mutation","Gastroesophageal Junction Squamous Cell Carcinoma","Advanced Solid Tumor","2026-06-10",{"date":426,"type":39},"2026-06-12",{"date":428,"type":39},"2025-12-01",{"date":430,"type":21},"2030-09",{"name":432,"class":70},"Plexium, Inc.",10,{"id":435,"slug":4,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":457},"100467347","NCT05365581","A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer","A Phase 1\u002F1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression","Inclusion Criteria (IC):\n\n* Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).\n* Female participant is not pregnant, confirmed by serum pregnancy test \\&vmedical evaluation by interview \\& at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration.\n* Female participant must agree not to breastfeed starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Female participant must not donate ova starting at screening \\& throughout the study period \\& for 6 months after the final study intervention administration.\n* Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant must not donate sperm during the treatment period \\& for 6 months after the final study intervention administration.\n* Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period \\& for 6 months after the final study intervention administration.\n* Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.\n* Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention.\n* Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has QT interval by Fredericia (QTcF) =\\\u003C 470 msec.\n* Participant agrees not to participate in another interventional study while receiving study Intervention in the present study.\n* Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study Intervention. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \\>= 1 week after any blood transfusion.\n\nMonotherapy Disease specific Criteria (MDSC): Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed metastatic, locally advanced unresectable gastric\u002Fgastroesophageal junction (GEJ) adenocarcinoma.\n* Escalation: Participant with gastric\u002FGEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with gastric\u002FGEJ adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment.\n\n  * Unique to EU: Expansion: Participant with gastric\u002FGEJ adenocarcinoma must have received at least first-line standard therapies in the metastatic setting, must have received ramucirumab treatment if eligible \\& where ramucirumab is available, \\& no more than 3 prior lines of systemic chemotherapy treatment.\n\nMDSC: Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.\n* Escalation: Participant with pancreatic adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).\n\n  * Unique to South Korea: Participant with pancreatic adenocarcinoma who has refused standard approved therapies is not allowed.\n* Expansion: Participants with pancreatic adenocarcinoma must have received no more than 2 prior lines of systemic chemotherapy treatment.\n\nNote: Participants with locally advanced unresectable pancreatic adenocarcinoma will not be admitted in monotherapy arms.\n\n* Unique to EU: Participant with pancreatic adenocarcinoma must have received at least first-line standard therapies in the metastatic setting \\& no more than 2 prior lines of systemic chemotherapy treatment.\n\nFor all participants in combination therapy (CT) administration:\n\n* If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCombination Therapy Disease-specific (CTDS) IC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma has progressed \\& must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nUnique to EU:\n\n* Participant must have a PD-L1 CPS ≥ 1.\n\nCTDS IC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must have previously received 1 line of systemic chemotherapy treatment (i.e., documented objective radiological or clinical disease progression after first line platinum \\& fluoropyrimidine treatment in the metastatic setting or disease progression during or within 4 months of the last dose of perioperative treatment.\n* For combination therapy with paclitaxel, female participant must follow contraception guidelines from time of informed consent through at least 7 months after final study intervention.\n\nCTDS IC: ASP2138 in Combination with mFOLFIRINOX as First-line Therapy in Pancreatic Cancer\n\n* Participant has histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.\n* Participant has confirmed metastatic or locally advanced unresectable pancreatic adenocarcinoma.\n* Participant has pancreatic adenocarcinoma, has progressed \\& must not have received prior systemic anticancer therapy for their advanced disease. However, participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as they were completed at least 6 months prior to enrollment and without disease progression or recurrence.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\n(Unique to South Korea: For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 15 months after final study intervention for women \\& 12 months after final study intervention for men).\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n\\- If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.\n\nCTDS IC: ASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer\n\n* Participant has histologically confirmed diagnosis of gastric\u002FGEJ adenocarcinoma.\n* Participant has metastatic or locally advanced unresectable gastric\u002FGEJ adenocarcinoma.\n* Participant with gastric\u002FGEJ adenocarcinoma must not have been previously treated for metastatic disease with either chemotherapy or prior checkpoint inhibitor therapy.\n* Participants have a HER2-negative tumor per local testing.\n* For CT with oxaliplatin, follow contraception guidelines from time of informed consent through at least 9 months after final study intervention.\n\nExclusion Criteria (EC):\n\n* Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration.\n* Participant has any condition which makes the participant unsuitable for study participation.\n* Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention.\n* Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.\n* Participant weighs \\\u003C 40 kg.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of study intervention. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent\u002Frecurrent vomiting.\n* Participant has significant gastric bleeding \\&\u002For untreated gastric ulcers that exclude the participant from participation.\n* Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable \\& have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention \\& are not requiring immunosuppressive doses of systemic steroids (\\> 10 mg per day of prednisone or equivalent) for longer than 2 weeks.\n* Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts \\>= 350 cells\u002FµL \\& no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus deoxyribonucleic acid test will be performed \\& if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.\n  * Participant treated for HCV with undetectable viral load results are eligible\n* Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.\n* Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.\n* Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has had a major surgical procedure 28 days before start of study intervention \\& has not fully recovered.\n* Participant has received radiotherapy metastatic or for locally advanced unresectable gastric\u002FGEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of study intervention \\& has NOT recovered from any related toxicity.\n* Participant has another malignancy for which treatment is required.\n* Participant who has received CLDN18.2-targeted therapy (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of study intervention administration is not eligible for dose escalation cohorts. However, a participant who has received CLDN18.2-targeted therapy greater than 28 days or 5 half-lives (whichever is longer) prior to first dose study intervention administration is eligible for dose expansion cohorts only, with the exception of participants who have experienced Grade \\>= 3 gastrointestinal toxicity after receiving an CLDN18.2-targeted therapy.\n* Participant has a history or complication of interstitial lung disease.\n\nChina Specific:\n\nParticipant who has received treatment with herbal medications that have known antitumor activity within 28 days prior to first dose of study treatment.\n\nFor all participants in CT administration:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& mFOLFOX6 \\[all components\\], ramucirumab \\& paclitaxel or mFOLFIRINOX \\[all components\\]).\n* For 5 FU (fluorouracil): Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded; however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FµL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention (Unique to EU: high blood pressure Stage 2 is defined as ≥ 140\u002F90 mmHg).\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n\nCTDS EC: ASP2138 in Combination with Pembrolizumab \\& mFOLFOX6 as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients that require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n\nCTDS EC: ASP2138 in Combination with Ramucirumab \\& Paclitaxel as Second-line Therapy in Gastric\u002FGEJ Cancer:\n\n* History of cerebrovascular accident or transient ischemic attack within 6 months prior to study intervention.\n* Participant has significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study intervention.\n* Participant has evidence of a bleeding diathesis or significant coagulopathy.\n* Participant has initiated new treatment with medications that affect the coagulation cascade with an INR ≥ 2 such as vitamin K antagonists, heparins \\& direct thrombin inhibitors or the use of factor Xa inhibitors within 28 days prior to the start of study intervention.\n\nNote: If the participant started receiving such medications more than 28 days prior to the start of study intervention \\& needs to continue, this is allowed. However, new anticoagulation medications may not be initiated within 28 days prior to the start of study intervention.\n\nJapan \\& Korea Specific:\n\nFor All Participants in ASP2138 in Combination with Pembrolizumab \\& CAPOX:\n\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention (i.e., pembrolizumab \\& CAPOX \\[all components\\]).\n* Participants who have received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to the first dose of study intervention are generally excluded, however, participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast or for chemotherapy (as part of CT administration) are allowed.\n* Participant is known to have HIV infection.\n* NOTE: Differing from monotherapy administration, participants with CD4+ T cell counts ≥ 350 cells\u002FμL \\& no history of AIDS-defining opportunistic infections within the past 6 months remain ineligible.\n* Participant has had uncontrolled high blood pressure within 6 months prior to the first dose of study intervention.\n* Participant has a history of ascites requiring drainage more than twice in the past 7 days.\n* Participant has known DPD deficiency.\n\nCTDS EC:\n\nASP2138 in Combination with Pembrolizumab \\& CAPOX as First-line Therapy in Gastric\u002FGEJ Cancer:\n\n* Participant has history of (noninfectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant received live-virus vaccination within 30 days prior to the first dose of study intervention.\n* Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Participants who require replacement therapy (e.g., thyroxine \\[T4\\], insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.",{"count":441,"type":21},398,[105],"Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments.\n\nThe main aims of the study are:\n\n* To check the safety of ASP2138 and how well people can tolerate medical problems during the study.\n* To find a suitable dose of ASP2138 to be used later in the study.\n* These are done for ASP2138 given by itself and when given together with the standard cancer treatments.\n\nAdults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a \"trigger\" such as infection, or have a specific heart condition (\"New York Heart Association Class III or IV\").\n\nPhase 1: Lower to higher doses of ASP2138\n\n* ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection).\n* Different small groups are given lower to higher doses of ASAP2138.\n* ASP2138 is either given by itself, or given with 1 of 3 standard treatments:\n* Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer)\n* Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer)\n* ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer)\n\nPhase 1b: doses of ASP2138 worked out from Phase 1\n\n* ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1.\n* People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1.\n* This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments.\n* The standard cancer treatments given depends on the type of cancer they have.\n\nEnd of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment.\n\nPeople who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.",[27,28,445],"Pancreatic Adenocarcinoma",[84,85,447,448,449],"Pharmacokinetics","Safety","Tolerability","2026-06-09",{"date":424,"type":39},{"date":453,"type":39},"2022-06-07",{"date":455,"type":21},"2028-05-31",{"name":95,"class":70},46,{"id":459,"slug":4,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":71},"100597524","NCT07059611","Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma","Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n* Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform the appropriate surgical procedure based on patient's primary tumor site.\n* Patients must have normal organ and bone marrow function, as defined below, less than or equal to 14 days prior to the initiation of study therapy:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmicroliter\n  * Platelets ≥100,000\u002Fmicroliter\n  * Total bilirubin ≤ the institutional upper limit of normal (ULN).\n  * AST and ALT ≤ 2.5 times the institutional ULN\n  * Serum creatinine ≤ 1.5 times the institutional ULN\n  * Hemoglobin ≥ 9 g\u002FdL\n\nExclusion Criteria\n\n* Has received prior chemotherapy, radiation therapy, or immunotherapy (anti-programmed cell death protein-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) for the current malignancy.\n* Per the investigator, has contraindications to receiving chemotherapy with FLOT.\n* Per the sub-investigator (gastroenterologist) responsible for intra-tumoral injections or the investigator, patient has contraindications to repeated upper endoscopy for intra-tumoral injections. These could include medical conditions that would, per the judgment of the sub-investigator or investigator, inappropriately increase the risk of upper endoscopy.\n* Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on warfarin with a target international normalized ratio (INR) ≥ 2.5 that cannot be temporarily reversed to INR ≤ 1.7.\n* Active significant herpetic infections or prior complications of Herpes simplex virus-1 (HSV-1) infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \\[IV\\]) antivirals with known antiherpetic activity (e.g., acyclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of study treatment.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Available COVID-19 vaccines do not contain live virus and are allowed.\n* Has a condition requiring systemic treatment with corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of first study treatment administration.\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10mg\u002Fday of prednisone equivalents are permitted.\n* Prior organ transplantation including allogeneic stem-cell transplantation.\n* Has a previous or concurrent malignancy. Exceptions include:\n\n  * Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\n  * Prior malignancy has been completely excised or removed and patient has been continuously disease free for \\> 5-years\n* Has a positive test result for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection with hepatitis B or hepatitis C. Testing will be performed as part of screening on the study.\n\n  * Patients with a known history of hepatitis B or hepatitis C that have been effectively treated (with negative HBsAg and HCV RNA) will be eligible for enrollment on this criterion.\n* Has a known history of human immunodeficiency virus (HIV) with detectable viral load. HIV testing will not be performed as part of screening for the study.\n\n  * Patients with known HIV infection with an undetectable viral load and who are on a stable highly active antiviral regimen per the investigator's assessment will eligible to enroll.\n* Has a psychiatric illness, substance use, or other social conditions that, in the judgment of the investigator, would limit compliance with study requirements.",{"count":465,"type":21},34,[24],"The research study is being conducted to study whether performing injections of a new treatment, called RP2, directly into stomach and esophagus tumors along with standard chemotherapy (called FLOT) is safe and whether it does a better job of killing cancer before surgery compared to chemotherapy alone.",[27,181,157],"2026-06-03",{"date":471,"type":39},"2026-06-05",{"date":473,"type":21},"2026-09-01",{"date":475,"type":21},"2029-11-01",{"name":477,"class":189},"Abramson Cancer Center at Penn Medicine",{"id":479,"slug":4,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":484,"sex":16,"minAge":485,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":226,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":71},"100630349","NCT07486518","A Multicentre Observational Cross-Sectional Study of The Gastric Precancerous Epithelial Pathway Using High-Definition Endoscopy And Histopathology In India","IND-PREP","1. Adults aged ≥40 years undergoing upper gastrointestinal endoscopy for dyspepsia or other clinical indications (nonalarming and alarming symptoms both).\n2. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Known gastric malignancy.\n2. Prior gastric surgery (excluding H. pylori eradication).\n3. Contraindications to endoscopy or biopsy.\n4. Known hereditary gastric cancer syndromes.",true,"40 Years",{"count":487,"type":21},4000,"To estimate the prevalence of histologically confirmed early gastric cancer (EGC) in an Indian multicentre cohort undergoing standardised high-quality upper gastrointestinal endoscopy. EGC is defined as gastric adenocarcinoma confined to the mucosa or submucosa (T1), irrespective of lymph node status, based on histopathology.",[27,490],"Early Gastric Cancer",{"date":492,"type":39},"2026-06-04",{"date":376,"type":21},{"date":495,"type":21},"2028-07-01",{"name":497,"class":189},"Asian Institute of Gastroenterology, India",{"id":499,"slug":4,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":22,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":526},"100627900","NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.",{"count":506,"type":21},174,[105],"This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[510,511,27,512,513,514,515,516,517],"Vulvar Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","GEJ Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Colorectal Cancer","Hormone Receptor Positive Breast Carcinoma","2026-05-29",{"date":286,"type":39},{"date":521,"type":39},"2026-03-31",{"date":523,"type":21},"2030-06",{"name":525,"class":70},"Avacta Life Sciences Ltd",3,{"id":528,"slug":4,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":533,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":536,"conditions":537,"keywords":540,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":548,"leadSponsor":550,"locationsCount":71},"100639523","NCT07621562","Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR\u002FMSS Gastric Cancer","Efficacy and Safety of a PCSK9 Inhibitor (Tafolecimab) Combined With Sintilimab and SOX in the Treatment of pMMR\u002FMSS Gastric Cancer: A Multicenter, Prospective, Single-Arm Exploratory Study","Inclusion Criteria:\n\n1. Fully understood the study and voluntarily signed the Informed Consent Form (ICF);\n2. Aged 18-75 years, male or female;\n3. Histopathologically confirmed pMMR\u002FMSS type gastric\u002Fgastroesophageal junction adenocarcinoma;\n4. Initially unresectable, advanced gastric\u002Fgastroesophageal junction adenocarcinoma;\n5. ECOG performance status 0-1;\n6. Life expectancy exceeding 3 months;\n7. Presence of measurable disease as confirmed by the investigator according to RECIST 1.1 criteria;\n8. Patients currently taking statin lipid-lowering medications must discontinue for ≥4 days before enrollment in this study;\n9. Adequate major organ function meeting the following requirements (laboratory values must meet the following criteria within 7 days before enrollment):\n\n   * Hematology (no transfusion, no granulocyte colony-stimulating factor \\[G-CSF\\], no medication correction within 14 days before screening):\n   * Neutrophils ≥ 1.5 × 10⁹\u002FL;\n   * Platelets ≥ 75 × 10⁹\u002FL;\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Biochemistry (no albumin infusion within 14 days before screening):\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance \\> 50 mL\u002Fmin;\n   * Serum total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's syndrome are allowed total bilirubin ≤ 3 × ULN);\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastases, ALT and AST ≤ 5 × ULN;\n\n   Coagulation function:\n\n   \\- International Normalized Ratio (INR) ≤ 2.3 or Prothrombin Time (PT) exceeding normal control by ≤ 6 seconds;\n10. No severe concomitant diseases leading to a life expectancy \\\u003C 5 years;\n11. Agree to provide blood and tissue samples for molecular biology testing;\n12. For patients with active Hepatitis B Virus (HBV) infection: HBV-DNA must be \\\u003C 500 IU\u002FmL (if the study center only uses copy\u002FmL units, must be \\\u003C 2500 copies\u002FmL), and willing to receive antiviral therapy throughout the study period; Hepatitis C Virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines and have liver function elevations within CTCAE Grade 1;\n13. Within 28 days before enrollment, females of childbearing potential must have a confirmed negative serum pregnancy test and agree to use effective contraception during study drug administration and for 60 days after the last dose. For this protocol, females of childbearing potential are defined as sexually mature women who: 1) have not undergone hysterectomy or bilateral oophorectomy; 2) have not been naturally postmenopausal for at least 24 consecutive months (cancer treatment-induced amenorrhea does not rule out childbearing potential) (i.e., have had menstruation at any time in the preceding 24 consecutive months). Male subjects' female partners of childbearing potential should also follow the above contraceptive requirements.\n\nExclusion Criteria:\n\n1. HER2 positive (IHC 3+, or IHC 2+ with positive in situ hybridization);\n2. EBER positive;\n3. CLDN18.2 positive (≥ 75% of tumor cells with membranous staining of IHC intensity 2+\u002F3+);\n4. Currently participating in other interventional clinical studies;\n5. Low-density lipoprotein cholesterol (LDL-C) controlled below 30 mg\u002FdL (≈ 0.78 mmol\u002FL);\n6. History of allergic reaction to PCSK9 inhibitors;\n7. Concurrent other active malignancy within the last 5 years besides gastric\u002Fgastroesophageal junction adenocarcinoma that has not recovered; Patients preparing for or having previously received organ or allogeneic bone marrow transplantation;\n8. Received major surgery (excluding diagnostic) within 4 weeks before start of study treatment or expected to require major surgery during the study (excluding radical gastrectomy);\n9. Currently have interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that might interfere with the judgment and management of immune-related pulmonary toxicity, or evidence of active pneumonitis on chest computed tomography (CT) scan during the screening period, or severely impaired pulmonary function.Subjects with radiation pneumonitis in the radiation field are allowed; active tuberculosis;\n\n11\\. Presence of active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects controlled by hormone replacement therapy alone can be included\\]); subjects with skin diseases not requiring systemic treatment such as vitiligo, psoriasis, alopecia, controlled Type I diabetes mellitus receiving insulin therapy, or childhood asthma that has completely resolved and requires no intervention in adulthood can be included; asthma patients requiring bronchodilators for medical intervention cannot be included; 12. History of uncontrolled epilepsy, central nervous system disease, or mental disorders, judged by the investigator as to whether clinical severity interferes with signing informed consent or affects patient compliance with medication; 13. Clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or more severe congestive heart failure, or severe arrhythmia requiring medical intervention, or history of myocardial infarction within the last 12 months; 14. Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 15. Allergy or contraindication to the components of the study drugs (PCSK9 inhibitor, PD-1 monoclonal antibody, or chemotherapeutic agents); 16. Prior receipt of any anti-tumor therapy for gastric\u002Fgastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, systemic therapy, etc.; 17. Use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or equivalent) within 14 days before the start of study treatment; 18. Patients with congenital or acquired immunodeficiency (e.g., HIV infection); 19. Co-infection with Hepatitis B and Hepatitis C; 20. Prior receipt of other anti-PD-1 antibody therapy or other immunotherapy targeting PD-1\u002FPD-L1, or prior receipt of PCSK9 monoclonal antibody therapy; 21. Receipt of live attenuated vaccine within 28 days before start of study treatment, or expected need for such vaccination during PD-1 monoclonal antibody treatment or within 60 days after the last dose of PD-1 monoclonal antibody; 22. Receipt of investigational drug (i.e., participating in another trial), anti-tumor cytotoxic drug therapy, biological drug therapy (e.g., monoclonal antibodies), immunotherapy (e.g., interleukin-2 or interferon) within 4 weeks before study enrollment; 23. Judged by the investigator, patients have other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring concurrent treatment, severe laboratory abnormalities, family or social factors, etc., that might affect subject safety or compliance; 24. Subjects with active tuberculosis (TB), receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year before screening; 25. Pregnant or breastfeeding women.",{"count":534,"type":21},30,[24],"Background:\n\nGastric cancer remains a significant health burden globally, particularly in China, where the majority of patients present with advanced disease at diagnosis. While immune checkpoint inhibitors (ICIs) targeting PD-1 have revolutionized treatment for various malignancies, their efficacy in proficient mismatch repair (pMMR) or microsatellite stable (MSS) gastric cancer-which constitutes over 85% of cases-remains limited. Recent Phase III trials (CheckMate 649, ATTRACTION-04, Orient-16) have demonstrated that combining PD-1 inhibitors with chemotherapy improves outcomes in advanced gastric cancer, leading to approved indications. However, the benefit in pMMR\u002FMSS populations is modest, highlighting an urgent need for novel combination strategies to overcome immunotherapy resistance.\n\nPreclinical research published in Nature (Liu et al., 2020) revealed that inhibiting PCSK9 (Proprotein Convertase Subtilisin\u002FKexin type 9)-a key regulator of cholesterol metabolism-can potentiate immune checkpoint therapy through a novel mechanism independent of its lipid-lowering function. PCSK9 inhibition was shown to increase tumor cell surface expression of MHC class I molecules by preventing their lysosomal degradation, thereby enhancing tumor antigen presentation and promoting cytotoxic T lymphocyte infiltration. This mechanistic insight suggests that combining a PCSK9 inhibitor with PD-1 blockade could synergistically improve antitumor immunity, particularly in immunologically \"cold\" tumors like pMMR\u002FMSS gastric cancer.\n\nTafolecimab is the first domestically developed fully humanized PCSK9 monoclonal antibody approved in China for hypercholesterolemia, with a favorable safety profile and extended half-life. Based on this strong preclinical rationale and the established efficacy of PD-1 plus chemotherapy in gastric cancer, this investigator-initiated trial aims to clinically translate the concept of PCSK9 inhibition as an immunomodulatory strategy.\n\nStudy Population:\n\nThis study will enroll 30 patients with the following key eligibility criteria:\n\nInclusion: Adults aged 18-75 years with histologically confirmed pMMR\u002FMSS gastric or gastroesophageal junction adenocarcinoma; initially unresectable or advanced disease (including metastatic); ECOG performance status 0-1; measurable disease per RECIST v1.1; adequate organ function.\n\nExclusion: HER2-positive, EBER-positive, or CLDN18.2-positive tumors; prior systemic anticancer therapy for advanced disease; active autoimmune disease requiring immunosuppression; uncontrolled intercurrent illness; LDL-C \\\u003C30 mg\u002FdL; history of PCSK9 inhibitor allergy; prior exposure to anti-PD-1\u002FPD-L1 or PCSK9-targeted therapies.\n\nStudy Objectives:\n\nThis is a multicenter, prospective, single-arm exploratory trial with a safety run-in phase (first 6 patients monitored for dose-limiting toxicities). The treatment regimen consists of:\n\nSintilimab (PD-1 inhibitor): 200 mg IV, day 1, every 3 weeks (Q3W) Tafolecimab (PCSK9 inhibitor): 300 mg subcutaneous injection, day 1, Q3W (dose reduction to 150 mg if DLTs occur) SOX chemotherapy: Oxaliplatin 130 mg\u002Fm² IV, day 1 + S-1 40 mg\u002Fm² orally twice daily, days 1-14, Q3W cycles Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.\n\nPrimary Endpoint:\n\nObjective Response Rate (ORR) assessed by RECIST v1.1\n\nSecondary Endpoints:\n\nProgression-Free Survival (PFS) Disease Control Rate (DCR) Conversion surgery rate and R0 resection rate Pathological Complete Response (pCR) and Major Pathological Response (MPR) rates in resected patients Overall Survival (OS) Safety and tolerability (incidence of TRAEs, ≥Grade 3 AEs, irAEs per CTCAE v5.0)\n\nExploratory Endpoints:\n\nAssociation between tumor biomarkers (including PD-L1 CPS, H. pylori infection status, and tumor PCSK9 expression) and treatment efficacy Multi-omics analyses using paired pre- and post-treatment tumor tissue, peripheral blood, and fecal samples\n\nSample Size and Duration:\n\nA fixed sample size of 30 patients will be recruited over approximately 12 months, with survival follow-up extending to 36 months. This exploratory study is designed to generate preliminary efficacy and safety signals to inform future larger-scale investigations. The safety run-in design ensures close monitoring for potential additive toxicities, particularly given the novel combination of PCSK9 inhibition with immunotherapy and chemotherapy.",[27,538,539],"Esophagogastric Juction Cancer","Proficient Mismatch Repair",[278,541,542,543,544],"Esophagogastric junction cancer","Proficient mismatch repair","Tafolecimab","Sintilimab","2026-05-27",{"date":286,"type":39},{"date":471,"type":21},{"date":549,"type":21},"2030-09-01",{"name":551,"class":189},"First Affiliated Hospital of Zhejiang University",{"id":553,"slug":4,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":526},"100634815","NCT07544589","A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers","A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers","Key Inclusion Criteria:\n\n1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma\n2. Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n4. Aged ≥18 years at time of signing informed consent\n5. Adequate organ function\n\nKey Exclusion Criteria:\n\n1. Previous solid organ or hematopoietic cell transplant\n2. Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy\n3. Known history of hepatitis B or HIV infection\n4. Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment\n5. Known active central nervous system (CNS) metastases\n6. Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis\n7. Active treatment with antiviral agents\n8. History of severe hypersensitivity to fludarabine or cyclophosphamide\n9. Prior therapies\u002Ftreatments with oncolytic viruses or T cell derived cellular therapy",{"count":559,"type":21},66,[105],"This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor \\[CAR\\] T), in adult participants with advanced gastrointestinal (GI) cancers.\n\nThe study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.",[516,27,181,267],[564,565,566,567,568,569],"CAR T","Adenovirus","ABECMA","BCMA","gastrointestinal cancer","CAR-T",{"date":518,"type":39},{"date":572,"type":21},"2026-04",{"date":574,"type":21},"2046-04",{"name":576,"class":70},"Dispatch Biotherapeutics",{"id":578,"slug":4,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":22,"phases":585,"briefSummary":586,"conditions":587,"keywords":590,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":433},"100525561","NCT06123338","A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer","A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors","Inclusion Criteria:\n\n* Age 18 years or older at time of signing informed consent.\n* ECOG performance status 0-1.\n* HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+\u002FFISH\\>2.0 expression.\n* Complete surgical resection of the primary tumor must be achievable\n* Demonstrate adequate organ function as defined in Table 1.\n\nTable 1 - Organ Function Requirements for Eligibility Hematological\n\n* Absolute neutrophil count (ANC): ≥1,500 \u002FmcL\n* Platelets: ≥100,000 \u002F mcL\n* Hemoglobin: ≥8 g\u002FdL Renal\n* Creatinine clearance: ≥ 50 mL\u002Fminute Hepatic\n* Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)\n* AST and ALT: ≤ 2.5 X ULN\n* Albumin: \\>3 mg\u002FdL Coagulation\n* International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): \\\u003C1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Male participants: A male participant must agree to use contraception as detailed in Section 15.3 of this protocol during the treatment period and for at least 230 days (5 terminal half-lives of trastuzumab \\[140\\] plus an additional 90 days \\[spermatogenesis cycle\\]) after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR\n  2. A WOCBP who agrees to follow the contraceptive guidance in section 15.3 during the treatment period and for at least 170 days (140 days plus an additional 30 days \\[menstruation cycle\\]) after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease.\n* Has received prior treatment for esophagogastric cancer\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.\n* Has received prior therapy with an anti-HER2 agent\n* Left ventricular ejection fraction \\\u003C50% within 1 month of screening by MUGA or echocardiogram. Patients with an ejection fraction 45-49% may be permissible in the absence of any cardiac symptoms, if cleared by a cardiologist, and per the investigator's discresion.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.\n* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.\n* Has a known history of active TB (Bacillus tuberculosis)\n* Hypersensitivity to pembrolizumab or any of its excipients\n* Has been diagnosed or treated for another malignancy in the past 3 years (not including non-melanoma skin cancer)\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has had an allogeneic tissue or solid organ transplant\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:\n\n  * Subjects with vitiligo or alopecia\n  * Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.\n  * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Is unwilling to give written informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study.",{"count":584,"type":21},49,[24],"The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.",[588,27,589],"Esophageal Cancer","HER2 Gene Mutation",[591,588,27,592,593,594,595,596,597],"HER2+ Esophageal cancer","HER2+ GEJ cancer","HER2 IHC3+ expression","IHC 2+\u002FFISH>2.0 expression","Esophagogastric cancer","Memorial Sloan Kettering Cancer Center","23-124","2026-05-26",{"date":65,"type":39},{"date":601,"type":39},"2024-02-01",{"date":603,"type":21},"2027-11-30",{"name":596,"class":189},{"id":606,"slug":4,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":71},"100638229","NCT07610629","Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer","Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Patients With Immunotherapy-Pretreated Gastric or Gastroesophageal Junction Cancer: A Prospective, Single-Arm Clinical Study","RA-A-NP","Inclusion Criteria:\n\n1. Able to provide written informed consent prior to any study-specific procedures\n2. Age ≥ 18 years\n3. ECOG performance status 0 or 1\n4. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic\n5. Human epidermal growth factor receptor 2 (HER2) negative\n6. Failed first-line immunotherapy-containing systemic treatment\n7. At least one measurable lesion per RECIST Version 1.1\n8. Adequate organ function:\n\n1)Hemoglobin ≥ 90 g\u002FL 2)Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL 3)Platelet count ≥ 80 × 10⁹\u002FL 4)Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN) 5)ALT\u002FAST \\\u003C 2.5 × ULN; \\\u003C 5 × ULN in patients with liver metastasis 6)Serum creatinine ≤ 1.5 × ULN or creatinine clearance \\> 60 mL\u002Fmin 7)Urine protein \\\u003C 2+ or 24-hour urine protein \\\u003C 1 g 8)Left ventricular ejection fraction (LVEF) ≥ 50% 9)Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN 8.Fertile male and female subjects must agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment; female subjects must have a negative pregnancy test within 7 days before enrollment\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the study drugs\n2. Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)\n3. Prior treatment with retlirafusp alf\n4. Received any investigational drug within 4 weeks before first dose\n5. Received systemic corticosteroid (\\> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except for allowed topical\u002Finhaled use or physiological replacement\n6. Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma)\n7. Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation\n8. Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention\n9. Severe infection (CTCAE Grade \\> 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis\n10. Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL) or active hepatitis C (HCV RNA positive)\n11. History of other malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ of cervix\n12. Pregnant or lactating women\n13. Unwilling or unable to comply with study procedures\n14. Any other condition deemed inappropriate by the investigator",{"count":613,"type":21},50,[24],"This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1\u002FTGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.",[27],[618,619],"Immunotherapy-Pretreated Gastric Cancer","retlirafusp alfa","2026-05-25",{"date":65,"type":39},{"date":623,"type":21},"2026-05-05",{"date":43,"type":21},{"name":626,"class":46},"Henan Cancer Hospital",{"id":628,"slug":4,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":11,"sex":16,"minAge":633,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":22,"phases":636,"briefSummary":638,"conditions":639,"keywords":642,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":71},"100637792","NCT07607119","PULSAR Combined With Immunotherapy for Unresectable Locally Advanced Gastric Cancer","A Prospective Phase II Study of Systemic Therapy With Immunotherapy Combined With Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) in Unresectable Locally Advanced Gastric Cancer","Inclusion Criteria:\n\nAge 19 or more years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. Histologically confirmed gastric adenocarcinoma. Tumor biomarker status: HER-2 negative, EBV negative, and Microsatellite Stable (MSS).\n\nUnresectable, locally advanced extent at initial staging (Para-aortic lymph node \\[PALN\\] and Supraclavicular lymph node \\[SCN\\] metastases are allowed).\n\nHas completed 3 or more cycles of first-line systemic therapy combined with immunotherapy without evidence of disease progression.\n\nPresence of at least one evaluable lesion according to RECIST v1.1 that is deemed safely irradiable by the investigator.\n\nVoluntary written informed consent provided by the subject.\n\nExclusion Criteria:\n\nPregnant or lactating women. Presence of brain metastases or leptomeningeal involvement. Prior history of radiation therapy to the intended target site. Severe uncontrolled comorbidities that, in the investigator's opinion, limit study participation or treatment compliance (e.g., uncontrolled infection, heart failure, arrhythmia, psychiatric illness).\n\nInability or unwillingness to comply with the study protocol procedures. Any condition deemed inappropriate for study participation by the principal investigator or attending physician.","19 Years",{"count":635,"type":21},53,[637],"NA","The purpose of this prospective, single-center, phase II study is to evaluate the clinical efficacy and safety of combining first-line systemic therapy plus immunotherapy with personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR) in patients with unresectable locally advanced gastric cancer.",[27,640,369,641],"Stomach Neoplasms","Unresectable Gastric Cancer",[643,644],"HER2-negative Stomach Cancer","Microsatellite Stable Gastric Cancer","2026-05-24",{"date":65,"type":39},{"date":648,"type":39},"2026-05-15",{"date":650,"type":21},"2030-04-30",{"name":652,"class":189},"Samsung Medical Center",""]