[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-cancer":669},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,46,78,108,135,159,183,214,241,263,290,320,343,369,391,415,445,466,486,522,541,577,608,629,651],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100572300",false,"NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).","ALL","18 Years",{"count":18,"type":19},726,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[25,26],"Gastric Cancer","Gastroesophageal Junction Cancer",[28,29,30,31,32],"Enhertu","Trastuzumab Deruxtecan","Chemotherapy","DS-8201a","HER2 positive","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2025-02-27",{"date":41,"type":19},"2030-02-01",{"name":43,"class":44},"Daiichi Sankyo","INDUSTRY",250,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100644605","NCT07671625","Comprehensive Perioperative Program Based on Prehabilitation, Nutritional Intervention and Psychological Support for Patients With Locally Advanced Operable Oesophagogastric Cancer","A Comprehensive Preoperative and Postoperative Program Consisting Of Active Physical Therapy, A Comprehensive Nutritional Plan, And Psychological Support For Patients With Locally Advanced, Resectable Cancer Of The Esophagus, Gastroesophageal Junction, and Stomach","OESOFIT","Inclusion Criteria:\n\n* Consent to participate in the study\n* Age ≥ 18 years\n* Patients with locally advanced esophageal or gastric cancer indicated for comprehensive perioperative treatment\n* Resectable disease\n* ECOG performance status 0-2\n* Ability to participate in a fitness program\n* Willingness to follow a nutritional plan and recommendations\n\nExclusion Criteria:\n\n* Disseminated disease",{"count":54,"type":19},60,[56],"NA","Perioperative chemotherapy (CHT) or CHT\u002FRT combined with surgery is the standard therapeutic approach for the treatment of locally advanced cancer of the esophagus, gastroesophageal junction (GEJ), and stomach. Comprehensive cancer treatment is associated with high perioperative morbidity and mortality. Serious postoperative complications occur in up to 20-80% of patients undergoing esophagectomy. The impact of nutritional status and overall physical condition on surgical outcomes and overall treatment has been demonstrated many times. The concept of pre-rehabilitation\u002Fpre-optimization, which involves establishing an individualized nutritional plan, monitoring and managing physical activity, and providing comprehensive supportive oncological and psychological care as early as during neoadjuvant CHT or CHT\u002FRT, is a prerequisite for improving perioperative and 30-day postoperative morbidity and mortality.",[59,26,25],"Locally Advanced Esophageal Cancer",[61,62,63,64,65,66],"autonomic nervous system","physiotherapy","gastric cancer","nutritional intervention","psychologic support","esophageal cancer","2026-06-25",{"date":69,"type":37},"2026-06-26",{"date":71,"type":37},"2023-05-02",{"date":73,"type":19},"2026-12-31",{"name":75,"class":76},"Masaryk Memorial Cancer Institute","OTHER",1,{"id":79,"slug":4,"hasResults":10,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":87,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100586941","NCT06921928","Study for AZD4360 in Participants With Advanced Solid Tumours","A Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Participant must be ≥ 18 at the time of signing the ICF.\n2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.\n\n4 Adequate organ and marrow function, as defined by protocol.\n\n5\\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.\n\n6\\. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G\u002FGEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.\n\n7\\. Participants must have received at least one prior line of systemic therapy in the advanced\u002Fmetastatic disease.\n\n8\\. At least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G\u002FGEJC participants.\n2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n3. Participants with clinically significant ascites that require drainage.\n4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.\n5. With spinal cord compression or with high risk of paralysis.\n6. History of non-infectious interstitial lung disease\u002Fpneumonitis.\n7. Participant has cardiac abnormalities, as defined by protocol.\n8. History of another primary malignancy within 2 years prior to screening.\n9. Known serologic status reflecting active hepatitis B or hepatitis C.\n10. Known HIV infection that is not well controlled.\n11. Active tuberculosis infection.","130 Years",{"count":86,"type":19},117,[88,89],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.",[25,26,92,93],"Biliary Tract Cancer","Pancreatic Ductal Adenocarcinoma",[25,26,92,93,95,96,97],"Advanced Solid Tumours","AZD4360","Claudin 18.2","2026-06-15",{"date":100,"type":37},"2026-06-16",{"date":102,"type":37},"2025-04-29",{"date":104,"type":19},"2027-12-16",{"name":106,"class":44},"AstraZeneca",18,{"id":109,"slug":4,"hasResults":10,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":20,"phases":116,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100623150","NCT07392892","Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer","A PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA","Inclusion Criteria:\n\n* Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Evidence of locally advanced or metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* No prior systemic therapy for advanced or metastatic disease.\n* Adequate hepatic, liver, and renal function\n* HER-2 negative status based on local testing\n* PD-L1 positive status based on local testing\n\nExclusion Criteria:\n\n* Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":115,"type":19},840,[89,22],"This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\nBe 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.\n\nThe treatment will be given in repeated time periods called cycles.",[119,120,26,121],"Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma","Metastatic Gastric Cancer","Esophageal Adenocarcinoma",[63,123,124],"gastroesophageal junction cancer","esophageal adenocarcinoma","2026-06-10",{"date":127,"type":37},"2026-06-12",{"date":129,"type":37},"2026-05-14",{"date":131,"type":19},"2032-07-21",{"name":133,"class":44},"Pfizer",71,{"id":136,"slug":4,"hasResults":10,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":20,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100637114","NCT07631000","A Study of Cadonilimab Combined With Chemotherapy in People With Gastric or Gastroesophageal Junction Cancer","A Phase 2, Single-arm Study of Cadonilimab and FLOT Chemotherapy in Patients With Locally Advanced, Resectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","Inclusion Criteria:\n\n* Capable of providing signed informed consent.\n* Age ≥18 years at time of informed consent.\n* ECOG performance status (PS) of 0 or 1 at enrollment.\n* Pathologically confirmed gastric or GEJ adenocarcinoma with T1 N+ M0 or T2-4 N0-3 M0 (per AJCC 8th edition) resectable disease deemed eligible for radical surgery. A diagnostic laparoscopy is strongly recommended to confirm M0 status.\n* HER2-negative tumor (IHC 0, 1+, or IHC 2+ and FISH non-amplified).\n* Adequate organ and marrow function as defined below:\n\n  1. Hemoglobin ≥9.0 g\u002FdL\n  2. Absolute neutrophil count ≥1.5 x 109\u002FL\n  3. Platelet count ≥100 x 109\u002FL\n  4. Serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled.\n  5. ALT and AST ≤2.5 x ULN\n  6. Albumin ≥2.8g\u002FdL (albumin infusion is not allowed within 14 days before the start of treatment)\n  7. Measured creatinine clearance \\>50 mL\u002Fmin as determined by Cockcroft-Gault using actual body weight 7. Willing and able to undergo pre-treatment (during screening) and on-treatment tumor biopsies.\n\n     8\\. Women of childbearing potential (as defined in Section 13.3) must have a negative serum pregnancy test within 72 hours prior to the first dose and agree to take effective contraception measures during the study drug administration and within 9 months after the last dose.\n\n     9\\. Male patients with female partners of childbearing potential (as defined in Section 13.3) must agree to take effective contraception measures during the study drug administration and within 6 months after the last dose.\n\n     Exclusion Criteria:\n* Histologies other than adenocarcinoma, including squamous\u002Fadenosquamous cell carcinoma, neuroendocrine, or GI stromal tumor.\n* HER2-positive tumor (IHC 2+ and FISH-amplified, or IHC 3+).\n* Prior anticancer treatment for the disease under study (chemotherapy, radiation therapy, chemoradiation, approved or investigational therapy) prior to initiation of study treatment.\n* Prior receipt of an anti-PD1 or anti-CTLA4 monoclonal antibody, including for prior non-gastric malignancy.\n* Underlying medical conditions that, in the Investigator's opinion, make the administration of cadonilimab hazardous, including but not limited to:\n\n  1. Interstitial lung disease (ILD), including history of ILD or non-infectious pneumonitis.\n  2. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of initiation of cadonilimab with the exception of prophylactic antibiotic treatment.\n  3. Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to initiation of study treatment, myocardial infarction within 6 months prior to initiation of study treatment, or unstable arrhythmia.\n  4. A condition or unresolved AE from a prior investigational drug that may obscure interpretation of toxicity determination or AEs.\n  5. History of prior solid-organ transplant, including allogeneic bone marrow transplant.\n* Concurrent chronic medical condition requiring the use of supraphysiologic doses of corticosteroids (\\>10 mg\u002Fday of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids not excluded).\n* Any active autoimmune disease or documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma or atopy.\n\n  1. Replacement therapy (e.g. insulin, levothyroxine) is not considered a form of systemic treatment.\n  2. Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections not excluded.\n  3. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome not excluded.\n* Known hypersensitivity to any excipient contained in the formulations of study interventions.\n* Prior active malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer(s), superficial bladder cancer, or carcinoma in-situ of the cervix, breast, or prostate cancer. Other cases of prior malignanices may be allowed after discussion with the Principal Investigator.\n* Known HIV infection with detectable viral load. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Known acute hepatitis B or chronic hepatitis B infection with active untreated disease. For patients with evidence of chronic infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Known hepatitis C infection with detectable viral RNA. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.\n* Receipt of a live attenuated vaccine within 30 days of study treatment initiation.",{"count":142,"type":19},37,[89],"The purpose of this study is to find out whether adding cadonilimab to the usual chemotherapy approach is an effective and safe treatment for participants with locally advanced\u002Fresectable gastric cancer or gastroesophageal junction (GEJ) cancer",[25,146],"Gastroesophageal-junction Cancer",[146,25,148,149],"Memorial Sloan Kettering Cancer Center","26-102","2026-06-01",{"date":152,"type":37},"2026-06-05",{"date":154,"type":37},"2026-05-27",{"date":156,"type":19},"2029-05-27",{"name":148,"class":76},7,{"id":160,"slug":4,"hasResults":10,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":165,"targetDuration":167,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":77},"100559027","NCT06558786","Registry for Esophageal and Gastroesophageal Junction Cancer","Prospective Registry Study of Multimodality Therapy for Oligometastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction","Inclusion Criteria:\n\n* Newly diagnosed stage IV adenocarcinoma of the esophagus or GEJ with OMD at the time of diagnosis, defined as the following:\n* Retroperitoneal lymph nodes (e.g., para-aortal, intra-aorto-caval, parapancreatic, or mesenterial lymph node)\n* Liver\n* Lung\n* Extra-abdominal lymph nodes (e.g., supraclavicular or cervical lymph nodes)\n* Adrenal gland\n* Unilateral or bilateral ovarian metastases (in the absence of gross or microscopic peritoneal disease \\[positive cytology\\])\n* Bone\n* ≤2 sites of disease (excluding the primary tumor and regional lymph nodes)\n* ≤3 tumors within each organ system\n* ≤5 metastases\n* All nonregional lymph nodes (including cervical, supraclavicular, and retroperitoneal nodal disease) are considered 1 discrete lesion\n* Satellite lesions in the primary esophageal malignancy, such as skipped esophageal primaries, are not considered metastatic sites\n* All sites of disease must be amenable to complete local therapy after systemic therapy, according to the treating physician. Treatment modalities include:\n* Surgery\n* Definitive chemoradiation\n* Stereotactic radiation\n* Ablation or similar techniques (e.g., irreversible electroporation)\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Presence of metastases, at the time of diagnosis, to the following:\n\n  * Peritoneum, including positive peritoneal lavage (on the basis of baseline diagnostic laparoscopy to rule out gross disease and positive peritoneal lavage cytology; laparoscopy may be omitted for patients in whom all sites of disease are above the diaphragm)\n  * Malignant pleural effusion\n  * Brain metastases or leptomeningeal disease\n  * Other sites not specifically noted must be reviewed and approved by the PIs\n  * Any site of disease that is not amenable to definitive local therapy\n* Unfit for best systemic therapy\n* Metachronous OMD\n* Secondary primary cancer, with the exclusion of basal cell carcinoma of the skin\n* Pregnant, lactating, or intending to become pregnant\n* Unwilling to provide informed consent",{"count":166,"type":19},50,"2 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding standard treatments for esophageal and Gastroesophageal Junction Cancer\u002FGEJ cancer. Researchers will use the information from this database to learn more about the effectiveness of different treatment options.",[146,171],"Esophageal Cancer",[173,174],"Quality-of-Life Assessments","24-206","2026-05-19",{"date":177,"type":37},"2026-05-22",{"date":179,"type":37},"2024-08-12",{"date":181,"type":19},"2029-08-12",{"name":148,"class":76},{"id":184,"slug":4,"hasResults":10,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":20,"phases":191,"briefSummary":192,"conditions":193,"keywords":195,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100506277","NCT05872295","IKS014 in Advanced Solid Tumors That Express HER2","A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors","Key Inclusion Criteria:\n\n* HER2 positive solid tumors with expression defined as IHC3+, IHC2+\u002FISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- \u002F+ or untested).\n* Participants with HR positive BC must have received prior treatment with a CDK4\u002F6 inhibitor, in countries where this is standard therapy.\n* Platelets ≥ 75,000 \u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count ≥ 1000\u002FmcL\n* No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration\n* Creatinine clearance \\> 45\u002FmL\u002Fmin (using the Cockcroft-Gault equation)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present\n* Total bilirubin ≤ 1.5 x ULN if no liver metastases or \\\u003C 3 x ULN with Gilbert's Syndrome or liver metastases at baseline\n* Albumin \\> 2.5 g\u002FdL\n* Prothrombin time or international normalized ratio (INR) and either partial thromboplastin time (PTT) or activated (a) PTT ≤ 1.5 x ULN, ≤ 3 x institutional ULN if anticoagulated.\n* Must have adequate treatment washout period before trial treatment, defined as: Major surgery (≥ 4 weeks) and radiation therapy (≥ 3 weeks; in case of palliative radiation ≥ 2 weeks)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS)\n* Part 2 Dose Expansion Cohorts May Include:\n\n  1. Advanced or metastatic BC that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH, as per ASCO-CAP and previously treated with at least two HER2 directed treatments.\n  2. Advanced or metastatic BC that has low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH-\u002F+ or untested) and previously treated with at least 1 prior line of therapy which may include chemotherapy and\u002For a HER2 directed ADC.\n  3. Advanced or metastatic GC or GEJ cancer that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH as per ASCO-CAP and previously treated with at least 1 prior line of therapy, which may include chemotherapy and\u002For a HER2 directed ADC.\n  4. Advanced or metastatic solid tumor that has been treated with standard of care therapy and is HER2 positive (HER2 IHC3+) as per ASCO-CAP or metastatic NSCLC (that has been treated with standard of care therapy) with a known activating HER2 (ERBB2) mutation.\n  5. Advanced or metastatic adenocarcinoma of the Esophagus that has been treated with at least one prior line of standard treatment, which may have included a HER2-directed therapy. The tumor must be HER2 positive defined either HER2 IHC3+ or HER2 IHC 2+\u002FISH+.\n\nKey Exclusion Criteria:\n\n* History of (noninfectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n* Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.\n* Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.\n* Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.\n* Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity.\n* Participant must not use contact lenses while participating in this study.\n* Central nervous system metastatic disease unless treated with definitive local therapy (surgical resection, stereotactic radiotherapy, or whole brain radiotherapy) and participant is clinically, radiologically and neurologically stable for at least 4 weeks prior to the first dose of study drug not on steroid therapy or are on a stable or decreasing dose of steroids for at least 7 days prior to first dose of study drug. Prophylactic anticonvulsant medications are allowed.\n* Active second malignancy or history of another malignancy within the last 2 years with the exception of:\n\n  * Treated, non-melanoma skin cancers\n  * Treated carcinoma in situ (CIS) (e.g., breast, cervix)\n  * Controlled, superficial carcinoma of the urinary bladder\n  * T1a or b carcinoma of the prostate treated according to local standard of care, with prostate specific antigen (PSA) within normal limits (WNL) for the institution\n  * Papillary thyroid carcinoma Stage I treated surgically for cure\n* Clinically significant cardiovascular disease or condition\n* Clinically significant liver disease\n* Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks prior to first trial drug administration.\n* Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy), including significant organ system dysfunction, or clinically significant laboratory abnormality(ies), which, in the opinion of the Investigator, would either compromise the participant's safety or interfere with obtaining informed consent, compliance with trial procedures, or evaluation of the safety of the trial drug.",{"count":190,"type":19},165,[88],"This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.",[194,25,146],"Breast Cancer",[196,197,198,199,200,201,202,203],"HER2","IKS014","Low HER2","Advanced tumors","HER2+","HER2-positive","HER2 expression","GEJ","2026-05-04",{"date":206,"type":37},"2026-05-08",{"date":208,"type":37},"2023-09-14",{"date":210,"type":19},"2027-12",{"name":212,"class":44},"Iksuda Therapeutics Ltd.",13,{"id":215,"slug":4,"hasResults":10,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":220,"enrollmentInfo":221,"targetDuration":223,"studyType":168,"phases":4,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":77},"100635596","NCT07554742","Non-Invasive Detection of claudin18.2 in Pancreatic and Gastric\u002FGastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging","Non-Invasive Detection of Claudin18.2 in Pancreatic and Gastric\u002FGastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging","Inclusion Criteria:\n\n1. Participants with histopathologically confirmed pancreatic cancer and gastric\u002Fgastroesophageal junction cancer with claudin 18.2 expression of any level, including treatment-naive patients with upfront resectable disease, patients with post-operative recurrent disease who are or become resectable following treatment, and patients rendered resectable after neoadjuvant or conversion therapy.\n2. Signed and dated informed consent form.\n3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.\n4. Male or female participants.\n5. Aged 18-75 years old.\n6. Good general performance status with an expected overall survival of more than 6 months.\n\nExclusion Criteria:\n\n1. Participants with prior Claudin 18.2 targeted therapy.\n2. Participants with concurrent other active malignancies.\n3. Participants with severe medical conditions that render them unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.\n4. Pregnant women and women who may be pregnant, women who are breastfeeding.\n5. Participants with poor compliance.","75 Years",{"count":222,"type":19},64,"3 Years","The purpose of this study is to use Claudin 18.2 (CLDN18.2)-targeted positron emission tomography (PET) imaging technology to evaluate its detection efficacy and diagnostic threshold for CLDN18.2-positive pancreatic cancer and gastric\u002Fgastroesophageal junction cancer, analyze the quantitative value of PET parameters in CLDN18.2 expression and their correlation with prognosis, and provide a basis for the precise selection of CLDN18.2-targeted therapy.",[226,25,26],"Pancreatic Cancer",[228,229,230,63,123],"claudin 18.2","PET\u002FCT","pancreatic cancer","NOT_YET_RECRUITING","2026-04-23",{"date":234,"type":37},"2026-04-28",{"date":236,"type":19},"2026-04-15",{"date":238,"type":19},"2029-03-31",{"name":240,"class":76},"Ruijin Hospital",{"id":242,"slug":4,"hasResults":10,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":20,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":77},"100453641","NCT05187182","CA-4948 in Combination With FOLFOX\u002FPD-1 Inhibitor +\u002F- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer","Phase I Trial of CA-4948 in Combination With FOLFOX\u002FPD-1 Inhibitor +\u002F- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer","Inclusion Criteria:\n\n* Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the stomach, gastroesophageal junction, or esophagus\n* Measurable or evaluable disease defined by RECIST 1.1.\n* Lesions amenable to research biopsy. This criteria can be waived by the PI after documented discussion with the treating physician.\n* Known HER2 status if histology is adenocarcinoma prior to enrollment; results from local CLIA laboratory is acceptable.\n\n  * For Dose Escalation, patients are required to have documented HER2 negative cancer.\n  * For Dose Expansion, patients will be enrolled to either HER2 positive or negative cohorts at the time of enrollment\n* No prior systemic treatment for unresectable\u002Fadvanced gastric, GEJ, or esophageal cancer.\n\n  * Neoadjuvant or adjuvant systemic therapy is allowed; however, surgical resection and adjuvant chemotherapy should have been \\> 3 months from planned C1D1.\n  * Up to two prior cycles of FOLFOX is allowed.\n  * Definitive chemoradiation is allowed if the last date of chemotherapy or radiation (whichever is more recent) is \\> 3 months from planned C1D1.\n  * Prior palliative radiation therapy, including brain radiation, in the unresectable setting is allowed, but the last treatment date should be \\>10 days from planned C1D1.\n* At least 18 years of age\n* ECOG performance status 0 or 1\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN in patients with documented Gilbert's syndrome\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.0 x IULN, unless there are liver metastases in which case AST and ALT ≤ 5.0 x IULN\n  * PT\u002FINR ≤ 1.5 x IULN\n  * aPTT ≤ 1.5 x IULN\n  * Creatinine clearance ≥ 35 mL\u002Fmin by Cockcroft-Gault\n* Creatinine phosphokinase (CPK) elevation at screening \\\u003C Grade 2 (CPK \\\u003C 2.5 x IULN)\n* Patients on a cholesterol lowering statin must be on a stable dose with no dose changes within 3 weeks prior to study start.\n* Expansion Cohort B patients only: LVEF above LLN as assessed by MUGA or ECHO\n* The effects of CA-4948 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 3 months after completion of the study\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment. Use of medical marijuana is permitted.\n* A history of other malignancy with the exception of 1) malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease; 2) or known indolent malignancies that do not require treatment and will likely not alter the course of treatment of metastatic gastric, GEJ, or esophageal cancer.\n* History of allogeneic organ or stem cell transplant\n* Currently receiving any other investigational therapeutic agents. Investigational tracers related to imaging studies are allowed with a 7 day-washout.\n* Currently have an intraluminal GI stent (gastric, esophageal, small bowel, colon). Biliary stents are allowed.\n* History of clinically relevant bleeding from their tumor(s). Includes but is not limited to bleeding tumor requiring RBC transfusion, or bleeding requiring more than one endoscopic intervention.\n* Untreated ulcerating tumor. Patients who are endoscopically treated must be assessed by the study PI or delegate for eligibility.\n* Use of systemic therapeutic anticoagulation, including daily baby aspirin, within 5 half-lives of the anticoagulant prior to C1D1. Patients can receive heparin or alteplase flush in their ports.\n* Use of anti-platelet therapies (i.e. P2Y12 inhibitors (clopidogrel, prasugrel, etc.), within 5 half-lives of the anti-platelet therapy prior to C1D1.\n* Use of NSAIDs within 5 half-lives of the NSAID prior to C1D1.\n* Clinically active CNS metastasis; treated and asymptomatic metastasis allowed at the discretion of the PI. Radiotherapy to the brain must be completed \\> 10 days prior to planned C1D1.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CA-4948, FOLFOX, nivolumab, trastuzumab or other agents used in the study.\n* Concomitant use of drugs with a known risk of causing prolonged QTc and\u002For Torsades de Pointes or a history of risk factors for Torsades de Pointes.\n* Presence of interstitial lung disease or pneumonitis ≥ G2\n* Administration of a live attenuated vaccine within 30 days prior to enrollment.\n* QTc (Bazett) \\>470ms on screening EKG\n* Gastrointestinal condition which could impair absorption of CA-4948 or inability to ingest CA-4948\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\\u003C 350 cells\u002FmcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e., for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).\n* Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll after discussing with the PI.\n* Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment except for adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: treatment with a short course of steroids (\\\u003C 5 days) up to 7 days prior to initiating study treatment is permitted. Inhaled intranasal, intra-articular, and topical steroid uses are permitted.\n* Patients are unwilling to adhere to the lifestyle guidance in protocol.",{"count":248,"type":19},42,[88],"This is a phase I trial of CA-4948 in combination with FOLFOX\u002FPD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX\u002Fnivolumab will be evaluated by BOIN algorithm.\n\nDose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX\u002Fnivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX\u002Fpembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.",[25,171,252,253,26],"Stomach Cancer","Esophagus Cancer","2026-04-21",{"date":256,"type":37},"2026-04-27",{"date":258,"type":37},"2023-06-02",{"date":260,"type":19},"2029-04-30",{"name":262,"class":76},"Washington University School of Medicine",{"id":264,"slug":4,"hasResults":10,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":20,"phases":271,"briefSummary":272,"conditions":273,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100538673","NCT06293898","Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age: ≥18 years\n2. Has a life expectancy of ≥3 months\n3. Has documented locally advanced or metastatic HER2expressing (IHC 1+ to 3+ and\u002For HER2 gene amplification or activating mutation in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:\n\n   1. Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)\n   2. Cohort 2: Subjects with HER2 expression in cervical cancers (CC)\n   3. Cohort 3: Subjects with HER2 expression in ovarian cancers (OC) including fallopian tube cancer and primary peritoneal cancer\n   4. Cohort 4: Subjects with HER2 expression in urothelial cancers (UC)\n   5. Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC)\n   6. Cohort 6: Subjects with HER2 expression in breast cancer (BC)\n   7. Cohort 7: Subjects with HER2 expression in lung cancer (LC)\n   8. Cohort 8: Subjects with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers\n4. Agree to provide most recent existing tumor samples (FFPE tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression:\n\n   1. In dose escalation and dose finding: archival tissue or fresh biopsy. If no archival tissue is available, or it is not possible to obtain a fresh tissue biopsy, medical monitor approval is required to screen subject;\n   2. In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.\n5. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1\n6. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n7. Toxicity of previous antitumor therapy has returned to Grade ≤1\n8. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n9. Has adequate organ function before enrollment, defined as:\n10. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range\n11. Urinary protein ≤2+ or ≤1000 mg\u002F24 hours\n12. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy test must be negative and subject must be nonlactating.\n13. Must agree to use adequate contraceptive measures during the treatment and for 6 months after the end of treatment for all subjects (regardless of gender)\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Subjects with history of severe heart disease\n3. Subjects with prolonged QT interval (QTc \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases\n5. Other malignant tumors diagnosed within 3 years prior to the first administration considered to be in remission\n6. Subjects with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n7. Subjects with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.\n8. Subjects with stroke, transient ischemic attack within 6 months before enrollment\n9. Subjects with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment\n10. Patients with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\\\u003C20 mg prednisone or equivalent\u002Fday) may participate.\n11. Subjects with pre-existing Grade ≥2 peripheral neuropathy Subjects who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL M07D1\n\n11\\. Subjects who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted 12. Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2 13.Subjects with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Subjects are allowed to participate if all the following criteria are met:\n\n1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n3. On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.\n\n   14\\. Subjects with known active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection). Subjects with a positive anti-HCV antibody are eligible only if PCR is negative for HCV RNA 15. Subjects with known active tuberculosis 16 .Subjects with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Subjects on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible.\n\n   17\\. Subjects who are pregnant or, breastfeeding, or planning to become pregnant during the study 18. Other conditions that the investigator or sponsor believes are not suitable for participating in this clinical trial.\n\n   16\\. Other conditions that the investigator believes are not suitable for participating in this clinical trial.",{"count":270,"type":19},280,[88],"The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.",[274,275,276,277,92,194,278,25,146,171],"Endometrial Cancer","Cervical Cancer","Ovarian Cancer","Urothelial Carcinoma","Lung Cancer",[196],"2026-03-20",{"date":282,"type":37},"2026-03-23",{"date":284,"type":37},"2024-02-09",{"date":286,"type":19},"2029-04-15",{"name":288,"class":44},"SystImmune Inc.",17,{"id":291,"slug":4,"hasResults":10,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":20,"phases":300,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":77},"100630045","NCT07482566","Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer","A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Proximal Gastrectomy and Total Gastrectomy in Patients With Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer","SIEWERT-RCT","Inclusion Criteria:\n\n* Age between 18 and 90 years\n* Histologically confirmed locally advanced Siewert type II-III gastroesophageal junction cancer\n* Considered operable after multidisciplinary tumor board evaluation\n* Candidate for curative surgical resection with D2 lymphadenectomy\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Early-stage gastroesophageal junction cancer\n* Gastric cancers located in the antrum or corpus\n* Severe anesthetic risk (American Society of Anesthesiologists \\[ASA\\] class IV or higher)\n* Pregnancy\n* Patients unwilling or unable to provide informed consent","90 Years",{"count":299,"type":19},120,[56],"This multicenter prospective randomized clinical trial aims to compare the safety and oncological effectiveness of proximal gastrectomy and total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Eligible patients will be randomly assigned to undergo either proximal gastrectomy or total gastrectomy using open, laparoscopic, or robotic surgical approaches according to clinical suitability. The primary outcome of the study is 3-year disease-free survival. Secondary outcomes include postoperative mortality, postoperative complications, and the number of metastatic lymph nodes retrieved. Patients will be followed for up to five years after surgery to evaluate long-term oncological outcomes.",[26,303,304],"Stomach Neoplasms","Esophageal Neoplasms",[306,307,308,309,310],"Siewert Type II","Siewert Type III","Proximal Gastrectomy","Total Gastrectomy","Gastric Cancer Surgery","2026-03-18",{"date":280,"type":37},{"date":314,"type":37},"2026-02-01",{"date":316,"type":19},"2033-02-01",{"name":318,"class":319},"Nurettin Şahin","OTHER_GOV",{"id":321,"slug":4,"hasResults":10,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":20,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"100556968","NCT06532006","A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer","A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer","Inclusion Criteria:\n\n1. Male\u002Ffemale who are at least 18 years of age on the day of signing the informed consent.\n2. With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n3. Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.\n4. HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.\n5. ECOG PS within 7 days before randomization: 0-1.\n6. Expected survival ≥ 6 months.\n7. Had adequate organ function\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors within 2 years before the randomization.\n2. Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Previous treatment with any HER2-target therapy.\n4. Active gastrointestinal bleeding\n5. Presence of central nervous system (CNS) metastases.\n6. Left ventricular ejection fraction (LVEF) \\\u003C 55%.\n7. Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.",{"count":327,"type":19},550,[22],"This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced\u002Fmetastatic adenocarcinoma of the gastric and\u002For gastroesophageal junction (G\u002FGEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).",[146,331,25,332],"Monoclonal Antibody","HER2-positive Gastric Cancer","2026-02-24",{"date":335,"type":37},"2026-02-27",{"date":337,"type":37},"2024-11-22",{"date":339,"type":19},"2028-09-01",{"name":341,"class":44},"Shanghai Henlius Biotech",208,{"id":344,"slug":4,"hasResults":10,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":20,"phases":351,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":368},"100532986","NCT06219941","AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.\n\nMaster Inclusion Criteria applicable to all sub studies:\n\n* Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.\n* Participants who are CLDN18.2 positive.\n* Must have at least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function as defined by protocol.\n* Body weight \\> 35 kg.\n* Participants are willing to comply with contraception requirements.\n\nSub study 1 Specific Inclusion criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Advanced or metastatic GC\u002FGEJC.\n* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nSub study 2 Specific Inclusion criteria:\n\n* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.\n* Availability of an archival sample or a fresh tumour biopsy taken at screening.\n* No prior treatments for unresectable or metastatic disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.\n\nSub study 3 Specific Inclusion criteria\n\n* Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).\n* Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nMaster Exclusion Criteria applicable to all sub studies:\n\n* Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n* Participants with clinically significant ascites that require drainage.\n* A history of drug-induced non-infectious ILD\u002Fpneumonitis.\n* Central nervous system metastases or CNS pathology.\n* Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.\n* History of another primary malignancy.\n* Prior exposure to any MMAE-based ADC.\n* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.\n\nSub study 1 Specific Exclusion criteria:\n\n* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC\u002FGEJC unless they have failed\u002Fnot tolerated\u002For are not eligible for standard anti-HER2 therapy, where available.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n* The use of concomitant medications known to prolong the QT\u002FQTc interval.\n\nSub study 2 Specific Exclusion criteria:\n\n* Known DPD enzyme deficiency based on local testing where testing is SoC.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Use of strong inhibitors or inducers of CYP3A4.\n* Known homozygous for the UGT1A1\\*28 allele based on local testing where testing is SoC.\n\nSub study 3 Specific Exclusion criteria\n\n• Clinically significant biliary obstruction that has not resolved before enrollment.",{"count":350,"type":19},224,[89],"The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.",[25,26,92,93],[355,356,357,92,358,97,359],"Gastric cancer","Gastroesophageal junction cancer","Pancreatic Ductal adenocarcinoma","Phase II","AZD0901","2026-02-11",{"date":362,"type":37},"2026-02-12",{"date":364,"type":37},"2023-12-13",{"date":366,"type":19},"2027-09-30",{"name":106,"class":44},52,{"id":370,"slug":4,"hasResults":10,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":20,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100601444","NCT07110571","A Trial of Adebrelimab Plus (SHR-A1811\u002FSHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric\u002FGEJ Cancer","A Multi-cohort, Multi-center Phase II Clinical Study of Adebrelimab in Combination With SHR-A1811\u002FSHR-A1904 and Chemotherapy or Adebrelimab in Combination With SHR-8068 as the Treatment in Subjects With Gastric or Gastroesophageal Junction Cancer","Inclusion Criteria:\n\n1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma who have not received prior anti-tumor therapy for gastric\u002Fgastroesophageal junction cancer.\n2. Age: ≥18 and ≤70 years, both male and female.\n3. Ability to provide fresh tumor tissue (preferred) or archival formalin-fixed paraffin-embedded (FFPE) tumor blocks\u002Funstained slides obtained within 6 months before enrollment.\n4. Availability of biomarker testing results before enrollment.\n5. ECOG performance status of 0-1.\n6. Life expectancy ≥ 6 months.\n7. Adequate organ and bone marrow function.\n8. Female participants must be either non-childbearing potential or of childbearing potential with a negative serum pregnancy test within 3 days prior to treatment initiation and not lactating. Childbearing-potential participants and their partners must agree to avoid sperm\u002Fovum donation and comply with contraception requirements from informed consent signing until 8 months after the last dose.\n9. Voluntarily signed informed consent form, with willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures.\n\nExclusion Criteria:\n\n1. Known squamous cell carcinoma, undifferentiated carcinoma, mixed adenocarcinoma with other histologic types, or other non-adenocarcinoma gastric cancers.\n2. 20% body weight loss within 2 months before enrollment.\n3. Prior treatments: Anti-tumor therapy for gastric\u002Fgastroesophageal junction cancer; Participation in other drug trials with last dose ≤4 weeks or ≤5 half-lives (whichever longer) before enrollment; Major surgery within 28 days before enrollment; Live attenuated vaccination within 28 days before enrollment or planned during\u002Fwithin 60 days after treatment.\n4. Known hypersensitivity to any study drug component (Adebrelimab, SHR-A1811, SHR-A1904, SHR-8068, fluorouracil, capecitabine, tegafur\u002Fgimeracil\u002Foteracil) or humanized monoclonal antibodies.\n5. Other malignancies within 5 years, except curatively treated basal\u002Fsquamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, ductal breast carcinoma in situ, or papillary thyroid cancer.\n6. History of immunodeficiency, organ transplantation, or active autoimmune disease.\n7. Clinically significant bleeding within 3 months or bleeding predisposition at screening; Arterial\u002Fvenous thromboembolism within 6 months or at screening.\n8. Non-healing wounds, active ulcers, or untreated fractures.\n9. Active severe gastrointestinal disorders.\n10. Interstitial pneumonia or lung disease.\n11. Severe cardiovascular\u002Fcerebrovascular diseases or metabolic disorders.\n12. Active HBV\u002FHCV infection or HBV-HCV co-infection.\n13. Active tuberculosis (TB) within 1 year by history\u002FCT, or prior untreated active TB \\>1 year ago.\n14. Severe infection within 4 weeks before first dose; CTCAE ≥Grade 2 active infection requiring systemic antibiotics within 2 weeks; Chronic infections potentially affecting treatment\u002Fsurgery.\n15. History of drug abuse or illicit substance use.\n16. Other conditions that may increase study risk, confound results, or render the patient unsuitable per investigator judgment.","70 Years",{"count":377,"type":19},200,[89],"This is a multi-cohort, multi-center Phase II clinical study exploring the efficacy of treatment with either Adebrelimab plus SHR-A1811\u002FSHR-A1904 and chemotherapy, or Adebrelimab plus SHR-8068 in patients with gastric or gastroesophageal junction (GEJ) cancer. The study also evaluates the safety and tolerability of these combination regimens.",[25,146],"2026-01-07",{"date":383,"type":37},"2026-01-09",{"date":385,"type":37},"2025-08-28",{"date":387,"type":19},"2027-05",{"name":389,"class":44},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.",2,{"id":392,"slug":4,"hasResults":10,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":20,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":412,"locationsCount":414},"100592880","NCT06999187","A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas","A Phase 1a\u002F1b, Multicenter, Open-label, Dose Escalation\u002FExpansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas","Inclusion Criteria:\n\n* Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+\u002FHER2-\u002F+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric\u002FGEJ, or urothelial that is unresectable, locally advanced or metastatic\n* Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available\n* Radiographically measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Life expectancy, in the opinion of the Investigator, of ≥ 3 months\n* Adequate marrow reserve, renal function, and hepatic function\n* Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor)\n* Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available\n* Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure\n\nExclusion Criteria:\n\n* Major surgery within 28 days prior to Day 1\n* Have not had an appropriate washout period from systemic therapy, including investigational agents, prior to C1D1:\n\n  1. Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter.\n  2. Antibody-based anticancer therapy: ≥ 4 weeks. Note: Treatment with systemic corticosteroids ≤ 25 mg\u002Fday (prednisone or equivalent) and inhaled or topical steroids are allowed. For participants with CRPC, LHRH agents are allowed.\n* Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor\n* Brain metastases either untreated and symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms. Brain metastases that have been treated and are no longer symptomatic are allowed if use of high-dose systemic corticosteroids (\\> 25 mg\u002Fday of prednisone or equivalent) is stopped ≥ 12 weeks prior to C1D1.\n* Active Grade ≥ 2 anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction.\n* Another malignancy (except for adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 1 year)\n* Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.\n* Current or past history of CNS disease, such as stroke, epilepsy, central nervous system vasculitis or neurodegenerative disease (participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits may be eligible).\n* QT interval for heart rate using Fridericia's formula (QTcF) \\> 480 msec or history of additional risk factors for Torsades de Pointes\n* Uncontrolled or significant cardiovascular disease\n* History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion or myocardial infarction within 6 months prior to C1D1.\n* Prior solid organ transplantation.\n* Known infection with HIV, HBV, or HCV. The following participants may be enrolled in this study (the Sponsor reserves the right to restrict enrollment of these participants):\n\n  1. Participants who are HIV-positive with undetectable HIV RNA and at least 3 months on antiretroviral therapy.\n  2. Participants with a positive serologic test for HBV (i.e., positive HBcAb and negative HBsAg) and have a negative PCR test.\n  3. Participants who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy and have a negative PCR test.\n* Active infection requiring systemic treatment, defined as requiring IV antimicrobial, antifungal, or antiviral agents within 2 weeks prior to C1D1. Prophylactic antimicrobial treatment is allowed. Infections eligible per Exclusion Criterion 16 may be enrolled.\n* Active clinical interstitial pneumonitis (e.g., shortness of breath, requirement of supplemental oxygen, dry cough) or as confirmed by means of diagnostic imaging within 6 months prior to C1D1.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.",{"count":398,"type":19},96,[88],"A phase 1a\u002F1b, multicenter, open-label, dose escalation\u002Fexpansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas",[402,403,404,275,405,93,406,274,276,25,146,277],"Triple Negative Breast Cancer","HER2-negative Breast Cancer","Non Small Cell Lung Cancer","Castrate Resistant Prostate Cancer","Head-and-neck Squamous Cell Carcinoma","2026-01-05",{"date":381,"type":37},{"date":410,"type":37},"2025-06-03",{"date":210,"type":19},{"name":413,"class":44},"Dren Bio",10,{"id":416,"slug":4,"hasResults":10,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":20,"phases":424,"briefSummary":425,"conditions":426,"keywords":429,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":77},"100617225","NCT07315854","Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer","A Prospective, Single-Center, Exploratory Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy in the Treatment of Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures.\n* Age 18-80 years, gender is not limited.\n* Patients with locally advanced unresectable, recurrent unresectable, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) confirmed by imaging and other examinations, and histopathologically confirmed as adenocarcinoma.\n* Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0\u002F1+, or IHC 2+ with FISH\u002FISH negative.\n* No prior systemic therapy for advanced or metastatic GC\u002FGEJC (including anti-HER-2 therapy). Patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC\u002FGEJC are eligible if the time to first recurrence or disease progression is greater than 6 months from the end of the last treatment. Prior use of anti-tumor Traditional Chinese Medicine preparations is allowed but must be discontinued at least 2 weeks before enrollment.\n* ECOG performance status score of 0 or 1.\n* Must have at least one measurable lesion according to RECIST v1.1 definitions.\n* All acute toxicities caused by prior anti-tumor therapy or surgery must have resolved to Grade 0-1 (according to NCI CTCAE v5.0) or to the level specified in the inclusion\u002Fexclusion criteria. Alopecia, fatigue, and hearing loss, or other toxicities considered by the investigator not to pose a safety risk to the subject, are excluded.\n* Adequate organ function (laboratory tests within 7 days prior to treatment):\n\n  * Hematology (No blood transfusion, G-CSF use, or drug correction within 14 days prior to screening):\n  * White blood cell count (WBC) ≥ 3,000\u002Fmm³ (3.0 × 10⁹\u002FL);\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10⁹\u002FL);\n  * Platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10⁹\u002FL);\n  * Hemoglobin (Hb) ≥ 9.0 g\u002FdL (90 g\u002FL).\n* Biochemistry (No albumin transfusion within 14 days prior to screening):\n\n  * Albumin ≥ 3.0 g\u002FdL (30 g\u002FL);\n  * Creatinine ≤ 1.5 × Upper Limit of Normal (ULN) or Creatinine Clearance ≥ 50 ml\u002Fmin (calculated using the Cockcroft-Gault formula);\n  * Total Bilirubin (BIL) ≤ 1.5 × ULN;\n  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 × ULN; for patients with liver metastases, ≤ 5 × ULN.\n* Coagulation: International Normalized Ratio (INR) ≤ 1.5, Prothrombin Time (PT), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n* Urine: Urine protein \\\u003C 2+; if urine protein is ≥ 2+, 24-hour urine protein quantification must be ≤ 1g.\n* Life expectancy ≥ 3 months.\n* Women of childbearing potential must undergo a serum or urine pregnancy test within 7 days before starting treatment, with a negative result, and must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n* Known squamous cell carcinoma, undifferentiated carcinoma, other histological types of gastric cancer, or mixed gastric cancer containing other histological types.\n* Active malignant tumors within the past 2 years, other than the tumor under study. Exceptions include subjects with locally curable cancers (that have been cured), such as basal or squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix or breast.\n* Participation in a study of an investigational drug or receipt of investigational treatment or use of an investigational device within 4 weeks prior to the first dose.\n* Enrollment in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study (defined as \\>4 weeks since the last dose of the previous clinical study or \\>5 half-lives of the study drug).\n* Untreated Central Nervous System (CNS) metastases, or uncontrolled or symptomatic active CNS metastases. Patients with fully treated CNS metastases may be enrolled if neurological symptoms have returned to baseline levels at least 4 weeks prior to enrollment (excluding residual signs or symptoms related to CNS treatment). Additionally, subjects must have discontinued corticosteroids or be on a stable or tapering dose of prednisone ≤ 10 mg\u002Fd (or equivalent dose of other corticosteroids) for at least 4 weeks prior to enrollment.\n* Pleural effusion or ascites that remains uncontrolled despite puncture and drainage within 14 days prior to enrollment; symptomatic or moderate-to-large pericardial effusion.\n* Weight loss of more than 20% within 2 months prior to enrollment.\n* Received the following treatments or medications prior to enrollment:\n\n  * Major surgery within 28 days prior to enrollment (tissue biopsy for diagnosis and PICC\u002Fport implantation are allowed).\n  * Use of immunosuppressive drugs within 14 days prior to enrollment, excluding nasal\u002Finhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤ 10 mg\u002Fd prednisone or equivalent).\n  * Vaccination with live attenuated vaccines within 28 days prior to enrollment or planned during the study period and within 60 days after the end of study drug treatment.\n  * Local anti-tumor therapy (e.g., radiotherapy or tumor embolization) within 28 days prior to enrollment.\n* Diagnosed with any other malignant tumor within 5 years prior to entering the study, except for cured cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma amenable to local treatment.\n* Presence of any active, known, or suspected autoimmune disease. Subjects in a stable state not requiring systemic immunosuppressive therapy are allowed, such as Type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia).\n* Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.\n* Significant clinical bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment; gastrointestinal perforation and\u002For fistula within 6 months prior to enrollment; arterial\u002Fvenous thromboembolic events within 6 months prior to enrollment, such as cerebrovascular accident (including TIA, cerebral infarction), deep vein thrombosis, and pulmonary embolism (except for those with gastric cancer bleeding\u002Fperforation where symptoms disappeared after surgical resection).\n* Major vascular disease within 6 months before the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).\n* Severe, unhealed, or dehisced wounds, active ulcers, or untreated fractures.\n* Presence of \\> Grade 1 peripheral neuropathy.\n* History of intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment, including incomplete obstruction related to the underlying disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. Patients with incomplete obstruction\u002Fobstruction syndrome at initial diagnosis who have symptom relief after definitive (surgical) treatment may be enrolled.\n* Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, etc.).\n* Known history of active tuberculosis.\n* Known allergy to the study drug or any of its excipients; or history of severe allergic reactions to other monoclonal antibodies.\n* HIV infection or known Acquired Immunodeficiency Syndrome (AIDS); untreated active hepatitis (Hepatitis B defined as HBV-DNA ≥ 500 IU\u002Fml; Hepatitis C defined as anti-HCV positive and HCV RNA above the lower limit of detection) or co-infection with Hepatitis B and C.\n* Poorly controlled clinical cardiac symptoms or diseases, such as: (1) NYHA Class II or higher cardiac insufficiency or LVEF \\\u003C 50% on echocardiography; (2) Severe\u002Funstable angina; (3) Myocardial infarction within 12 months prior to enrollment; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) Symptomatic congestive heart failure; (6) QTc \\> 480 ms.\n* Systemic use of antibiotics ≥ 7 days within 4 weeks prior to enrollment, or unexplained fever \\> 38.5°C during screening\u002Fbefore first dose (fever due to tumor causes is allowed per investigator judgment).\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Participation in any other drug clinical study within 4 weeks or 5 half-lives prior to enrollment.\n* Known history of psychotropic drug abuse or drug addiction.\n* Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participation, interfere with study results, or render the patient unsuitable for the study in the opinion of the investigator.","80 Years",{"count":423,"type":19},32,[89],"The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer.\n\nThe main questions it aims to answer are:\n\n1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will：\n\n1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks.\n2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles.\n3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity.\n4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.",[427,26,428,120],"Gastric Cancer (GC)","Advanced Gastric Cancer",[430,431,432,433,434,435,25],"Iparomlimab and Tuvonralimab","QL1706","Advanced or Metastatic Gastric Cancer","PD-1\u002FCTLA-4 Bispecific Antibody","Immunotherapy","Chemotherapy Combination","2026-01-02",{"date":438,"type":37},"2026-01-06",{"date":440,"type":37},"2025-11-04",{"date":442,"type":19},"2029-12-31",{"name":444,"class":76},"Beijing Friendship Hospital",{"id":446,"slug":4,"hasResults":10,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":20,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":4},"100523269","NCT06093425","Combination of Osemitamab (TST001), Pembrolizumab and Chemotherapy as First-line Therapy in Advanced or Metastatic GC\u002FGEJ Adenocarcinoma","A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating Combination of TST001, Pembrolizumab and Chemotherapy as First-Line Treatment in Subjects With Claudin18.2 Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G\u002FGEJ) Adenocarcinoma","Inclusion Criteria:\n\n* 1\\. ≥18 years of age on day of signing informed consent. 2. Histologically or cytologically confirmed diagnosis of previously untreated, unresectable locally advanced or metastatic G\u002FGEJ adenocarcinoma.\n\n  3\\. Must be willing and able to provide archival or fresh tissue sample, a formalin-fixed, paraffin-embedded (FFPE) block, or 151 or more unstained, freshly cut, serial sections (on slides) from an FFPE tumor specimen or fresh biopsy tissue from a tumor lesion (either primary or metastatic) not previously irradiated fixed in formalin solution. FFPE tissue blocks are preferred to slides. Notes: details pertaining to tumor tissue submission can be found in the Laboratory Manual. Fresh biopsies are not required for study entry and will not be covered as part of the study procedures. Handling of the fresh biopsy tissue is an alternative offered to investigators in case they plan to biopsy the subjects as part of their standard of care; the fresh sample can be sent directly to the central laboratory if it is more convenient to the sites.\n\n  4\\. Positive CLDN18.2 expression in tumor tissue confirmed by the central laboratory at screening using CTA (Claudin 18.2 IHC 14G11 pharmDx).\n\n  5\\. Must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria as assessed locally by the investigator; radiographic tumor assessment should be performed within 28 days prior to randomization.\n\n  6\\. Subjects should be eligible to receive chemotherapy and pembrolizumab per the investigator judgement.\n\n  7\\. Known PD-L1 CPS Status (tested by central laboratory to provide CPS status by PD-L1 IHC 22C3 pharmDx).\n\n  8\\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 14 days before randomization.\n\n  9\\. Subjects who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or pre-treatment status. Subjects with endocrine-related AEs who are adequately treated with hormone replacement or subjects who have ≤Grade 2 neuropathy are eligible.\n\n  10\\. Have a life expectancy of greater than 12 weeks. 11. Demonstrate adequate organ function.\n\nExclusion Criteria\n\n1. Has received any prior systemic anticancer treatment (chemotherapy, immunotherapy, biologic therapy, or targeted therapy) for G\u002FGEJ adenocarcinoma. Neo\u002Fadjuvant treatment is permitted as long as it was completed at least 6 months prior to randomization.\n2. Has received prior radiotherapy within 2 weeks before randomization; Note: Subjects must have recovered from all radiation-related toxicities. A previously irradiated lesion can be used as measurable lesion as long as it progressed post radiation therapy.\n3. Has received anti-CLDN18.2 agents at any time.\n4. Has received any traditional Chinese medicine or proprietary Chinese medicine with anti-tumor effect within 7 days before randomization.\n5. Has received vaccines (live, attenuated, or research vaccines) within 30 days before randomization. Administration of killed vaccines is allowed.",{"count":452,"type":19},820,[22],"Gastric\u002FGEJ adenocarcinomas are aggressive tumors with a high probability of death. Current treatment guidelines include two-drug cytotoxic chemotherapy with a fluoropyrimidine (mFOLFOX6: capecitabine or fluorouracil) and a platinum-based agent (CapOx: oxaliplatin or cisplatin). In addition, the FDA has approved nivolumab, a PD-1 checkpoint inhibitor, in combination with chemotherapy as first line treatment for advanced or metastatic gastric\u002FGEJ cancer. TST001 is a recombinant humanized monoclonal antibody against Claudin 18.2 (a tumor marker found in gastric\u002FGEJ cancer. In this study, the combination therapy of chemotherapy or chemotherapy and pembrolizumab with and without TST001 could provide additional benefits to the management of these tumors.",[25,146,456],"Advanced Cancer","2025-12-12",{"date":459,"type":37},"2025-12-17",{"date":461,"type":19},"2026-06-30",{"date":463,"type":19},"2030-01-31",{"name":465,"class":44},"Suzhou Transcenta Therapeutics Co., Ltd.",{"id":467,"slug":4,"hasResults":10,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":10,"sex":15,"minAge":472,"maxAge":220,"enrollmentInfo":473,"targetDuration":4,"studyType":20,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":4},"100612967","NCT07260461","The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.","A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.","Inclusion Criteria:\n\n1. Aged from 18 to 75 years old;\n2. Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;\n3. The tumor was located in the proximal third of the stomach.\n4. ECOG score of 0 or 1;\n5. D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).\n6. ASA grade I to III;\n7. The preoperative nutritional status of the patients was good without severe malnutrition.\n8. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n2. Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;\n3. Severe respiratory diseases: severe impairment of lung function (FEV1%\\\u003C50%) or chronic respiratory failure;\n4. Severe liver and kidney dysfunction: ALT\u002FAST \\> 3 times the upper limit of normal, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²;\n5. patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;\n6. Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.\n7. Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;\n8. Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;\n9. Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);\n10. Pregnant or lactating women;\n11. Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;\n12. Severe malnutrition before surgery: BMI \\\u003C 16 kg\u002Fm² or albumin \\\u003C 25 g\u002FL;\n13. Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).","15 Years",{"count":299,"type":19},[56],"This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach.\n\nThe current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux.\n\nThe main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes.\n\nThe study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.",[303,477,26],"Adenocarcinoma - Gastroesophageal Junction (GEJ)","2025-12-02",{"date":480,"type":37},"2025-12-03",{"date":482,"type":19},"2026-01-01",{"date":339,"type":19},{"name":485,"class":76},"First Affiliated Hospital of Wenzhou Medical University",{"id":487,"slug":4,"hasResults":10,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":20,"phases":494,"briefSummary":495,"conditions":496,"keywords":502,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100326192","NCT03526835","A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","Phase 1\u002F2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe\u002Ffeasible).\n* Amenable for biopsy (if safe\u002Ffeasible).\n* Measurable disease as defined by RECIST version 1.1 by radiologic methods.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks, as per investigator.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).\n* Adequate organ function\n* Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:\n\nSINGLE AGENT:\n\n* SECOND-\u002FTHIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease.\n\n  * Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.\n  * The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* 3L+ mCRC (cohort open to enrolment) patients must have:\n\n  * No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) amplification, as detected in plasma by ctDNA NGS central testing performed during screening.\n  * A microsatellite stable (MSS) tumor.\n\nCOMBINATION:\n\n* FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.\n* mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS\u002FRAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.\n\n  * Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.\n  * Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab.\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.\n* Known leptomeningeal involvement.\n* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.\n* Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.\n* Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)\n* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.\n* Persistent grade \\>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.\n* History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg) with appropriate treatment or unstable angina.\n* History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia).\n* History of myocardial infarction within 6 months of study entry.\n* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy.\n* Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.\n* Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.\n* Patients with known infectious diseases:\n\n  * Active hepatitis B infection ((hepatitis B surface antigen \\[HBsAg\\] positive) without receiving antiviral treatment.\n  * Positive test for hepatitis C ribonucleic acid (HCV) RNA).\n* Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.",{"count":493,"type":19},523,[88,89],"This is a Phase 1\u002F2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.\n\nThe dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC).\n\nThe study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.",[497,498,25,146,499,500,501,171],"Advanced\u002FMetastatic Solid Tumors","Colorectal Cancer","NSCLC","HNSCC","Head and Neck Squamous Cell Carcinoma",[503,504,505,506,507,508,509,510,511],"Bispecific antibody","First-in-human","MCLA-158","Antibodies","Bispecific","immunologic factors","Cytokines","EGFR","LGR5","2025-01-27",{"date":514,"type":37},"2025-01-29",{"date":516,"type":37},"2018-05-02",{"date":518,"type":19},"2027-11",{"name":520,"class":44},"Merus B.V.",45,{"id":523,"slug":4,"hasResults":10,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":220,"enrollmentInfo":528,"targetDuration":4,"studyType":20,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":539,"locationsCount":4},"100547684","NCT06411171","Safety and Efficacy of Pembrolizumab in Combination With FLOT About Gastroesophageal Junction Cancer:","Safety and Efficacy of Pembrolizumab in Combination With FLOT as a First-line Treatment in Patients With Gastroesophageal Junction Cancer: a Prospective Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\) aged from 18 to 75 years old, including 18 and 80 years old;\n\n  2\\) histologically or cytologically confirmed locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma;\n\n  3\\) ECOG PS score 0 or 1;\n\n  4\\) Known PD-L1 expression (assessed centrally using PD-L1 HC22C3)\n\n  5\\) no previous treatment\n\n  6\\) HER2-negative status\n\n  7\\) normal hematological parameters: white blood cell count ≥4×109\u002FL; Absolute neutrophil count ≥1.5×109\u002FL; Platelet count ≥100×109\u002FL; Blood red protein g\u002FL;\n\n  8\\) basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl)\\> 60 mL\u002Fmin(using Cockcroft-Gault formula):\n\nFemale CrCl=(140-age)× weight (kg)× 0.85 \u002F (72×Scr mg\u002Fdl)\n\nMale CrCl=(140-age)× weight (kg)× 1.00 \u002F (72×Scr mg\u002Fdl)\n\nLiver function was basically normal: serum total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) ≤2.5×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN.\n\nFemale patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and\u002For hysterectomy or postmenopausal patients)\n\n9\\) Provide written informed consent. Written informed consent was obtained.\n\nExclusion Criteria:\n\n* 1\\) receiving anti-tumor therapy before enrollment, including but not limited to PD-1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-Tkis, and anti-angiogenic drugs;\n\n  2\\) A history of autoimmune disease, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Note: Patients with vitiligo, type I diabetes, or residual hypothyroidism due to autoimmune conditions (e.g., after Hashimoto's syndrome) requiring only hormone-replacement therapy, psoriasis requiring no systemic therapy, or if recurrence was not expected in the absence of an external trigger were allowed.) ;\n\n  3\\) participated in other interventional clinical trials within 30 days before screening;\n\n  4\\) Patients with a history of other malignant tumors (except cured basal cell carcinoma)\n\n  5\\) with severe uncontrolled comorbidities (e.g., heart failure, diabetes mellitus, hypertension, liver failure, renal failure, thyroid disease, mental illness, etc.);\n\n  6\\) known HIV infection or active viral hepatitis or tuberculosis;\n\n  7\\) have a major surgical procedure or planned surgery within 30 days before the first dose of the trial drug;\n\n  8\\) patients who are allergic to the drugs used in this regimen or their components;\n\n  9\\) pregnant (confirmed by blood or urine HCG testing) or lactating women, or childbearing age subjects unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;\n\n  10\\) The investigator considers that it is not appropriate to participate in the study;\n\n  11\\) unwilling to participate in the study or unable to sign an informed consent form",{"count":529,"type":19},36,[22],"At present, surgery is still the main treatment for gastroesophageal junction cancer. At the same time, multimodal comprehensive treatment such as chemotherapy and molecular targeted therapy can effectively alleviate pathological progression, facilitate R0 resection and improve the overall survival of patients.Pembrolizumab, as a PD-1 inhibitor, has been shown to have antitumor activity and a manageable safety profile in gastroesophageal junction cancer.Pembrolizumab combined with chemotherapy has become a research hotspot. However, to date, there is no clinical study related to gastroesophageal junction cancer. In this study, Pembrolizumab combined with FLOT was used as the first-line treatment for gastroesophageal junction cancer, aiming to explore the experience chemotherapy mode for gastroesophageal junction cancer.",[26],"2024-05-15",{"date":535,"type":37},"2024-05-17",{"date":537,"type":19},"2024-06-01",{"date":339,"type":19},{"name":540,"class":76},"xiaohua li",{"id":542,"slug":4,"hasResults":10,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":220,"enrollmentInfo":548,"targetDuration":4,"studyType":20,"phases":550,"briefSummary":551,"conditions":552,"keywords":560,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":77},"100525435","NCT06121700","Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer","Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial","Miracle-G","Inclusion Criteria:\n\n1. Histopathologically confirmed adenocarcinoma of stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I).\n2. Limited metastatic status of disease.\n3. At least one evaluable lesion in CT\u002FMRI according to RESIST 1.1 is required.\n4. The status of HER2 is clear.\n5. pMMR\u002FMSS confirmed by immunohistochemistry or gene test.\n6. Male or female. Patient age ≥ 18 years and ≤ 75 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n8. Physical state or organ function can tolerate the planned treatment of the study protocol, including systematic chemotherapy, immunotherapy with anti-PD-1 monoclonal antibody (mAb), primary lesion radiotherapy, metastatic lesion radiotherapy, and surgical resection of primary and\u002For metastatic lesions.\n9. No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.\n10. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; platelet count ≥ 100×109\u002FL; hemoglobin level ≥ 90 g\u002FL.\n11. Adequate hepatic function: total bilirubin ≤ 1.5×upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN in the absence of liver metastases, or \\\u003C 5 × ULN in case of liver metastases; ALP ≤ 2.5×ULN; ALB ≥ 30 g\u002FL.\n12. Adequate renal function: serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml\u002Fmin.\n13. Adequate coagulation function: INR\u002FPT ≤ 1.5×ULN; APTT ≤ 1.5×ULN.\n14. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. 13. If the level of T3\u002FT4 is normal, the patients can be selected.\n15. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g.\n16. There is no serious concomitant disease, and the patient's life expectancy is more than 6 months.\n17. Patients agree to sign written informed consent before recruitment.\n18. Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n19. Patients are willing to provide samples of blood and tissue.\n20. Female patients should not be pregnant or breast feeding.\n21. Female patients agree to take contraceptive measures during treatment and within 120 days after the last dose of anti-PD-1 mAb or 180 days after the last use of chemotherapy or radiotherapy.\n\nDefinition of the limited metastatic disease:\n\n1. Retroperitoneal lymph node metastases (RPLM) only or at maximum one organ involved with or without RPLM.\n2. There is no peritoneal seeding on diagnostic laparoscopy (P0).\n3. The definition of RPLM includes but is not limited to para-aortal, intra-aorto-caval, parapancreatic or mesenteric lymph nodes. If the duodenum is invaded, retropancreatic nodes are not regarded as M1.\n4. The definition of single organ metastasis in the study is as follows: a) Liver: maximum of 5 metastatic lesions that are potentially resectable and the metastases should be limited to one lobe and not involve important blood vessels or bile ducts. b) Lung: unilateral involvement, potentially resectable. c) Ovary: uni- or bilateral Krukenberg tumors in the absence of macroscopic peritoneal carcinomatosis. d) Adrenal gland: uni- or bilateral metastases. e) Extra-abdominal lymph node metastases, such as supraclavicular or cervical lymph node involvement. f) Bone: localized bone involvement (defined as being within one radiation field).\n5. Other metastatic disease locations are considered, limited by the investigator and confirmed by the multidisciplinary team (MDT).\n\nExclusion Criteria:\n\n1. Patients who have previously received surgery, chemotherapy, radiotherapy or immunotherapy for gastric cancer.\n2. Patients have a history of cancer in the five years before enrollment except for squamous or basal cell carcinoma of the skin that was effectively treated and superficial bladder cancer, cervical carcinoma in situ and breast cancer in situ that was treated by operation.\n3. Pregnant or lactating females or females planning to become pregnant or lactating. Women of childbearing age with a positive pregnancy test or without a pregnancy test in the baseline period. Menopausal women must have stopped menstruating for at least 12 months before being considered to have no chance of pregnancy.\n4. Patients who had sexual activity (with the possibility of childbirth) and were unwilling to use contraception during the study period.\n5. Patients with a history of allergies to any drugs that may be used in this study, including chemotherapy drugs.\n6. History of allogeneic stem cell transplantation or organ transplantation.\n7. Vaccinated with live vaccine within 28 days before recruitment.\n8. Immunotherapy (interleukin, interferon, thymine) or other experimental treatment was given 28 days before enrollment.\n9. History of anti-PD-1, PD-L1, PD-L2 or any other specific T-cell costimulation or checkpoint pathway targeted therapy.\n10. History of using steroids (dose \\> 10 mg\u002Fd prednisone) or other systemic immunosuppressive therapy within 14 days before recruitment, except for patients treated with the following regimen: steroids used for hormone replacement (dose \\> 10 mg\u002Fd prednisone); local application of steroids with little systemic absorption; short-term (≤ 7 days) use of steroids to prevent allergy or vomiting.\n11. Patients with weight loss of more than 20% within 2 months before recruitment.\n12. Uncontrolled systemic diseases, including diabetes, hypertension, etc.\n13. Uncontrollable pleural effusion, pericardial effusion, or ascites occurred within two weeks before recruitment.\n14. Failure of important organs (heart, lung, liver, kidney, etc.).\n15. Moderate or severe renal injury \\[creatinine clearance ≤ 50 ml\u002Fmin (according to Cockcroft \\& Gault equation)\\], or SCR \\> ULN.\n16. Dipyrimidine dehydrogenase (DPD) deficiency.\n17. Patients with central nervous system (CNS) disorders or tumors, including brain metastases, peripheral nervous system disorders or psychiatric diseases.\n18. Cerebrovascular accidents occurred within 6 months before recruitment.\n19. Patients with peripheral neuropathy of NCI-CTCAE grade 1, except for those with disappearance of the deep tendon reflex.\n20. Patients with a known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, congestive heart failure, cardiac infarction or cardiac insufficiency within 6 months prior to study recruitment.\n21. Pulmonary embolism occurred within 28 days before enrollment.\n22. Patients who had the following history of pulmonary diseases: interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or acute lung disease.\n23. Patients with gastrointestinal bleeding or a high risk of bleeding within the first 2 weeks of enrollment.\n24. Patients who experienced gastrointestinal perforation or fistula within 6 months prior to enrollment.\n25. Upper gastrointestinal obstruction, dysfunction or malabsorption syndrome may affect the absorption of oral chemotherapy drugs.\n26. Patients who cannot swallow or take medication orally.\n27. Patients with a history of active autoimmune disease or refractory autoimmune disease.\n28. Severe chronic or active infections requiring systemic antibiotics, antifungal or antiviral therapy, including tuberculosis and AIDS.\n29. Known history of human immunodeficiency virus (HIV) infection.\n30. Patients with untreated chronic hepatitis B or HBV-DNA exceeding 500 IU\u002Fml or HCV-RNA positive.\n31. Alcohol\u002Fdrug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results.",{"count":549,"type":19},55,[89],"The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients.\n\nParticipants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+\u002FISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.",[553,554,146,555,556,120,557,558,559],"Adenocarcinoma","Stomach Neoplasm","Oligometastatic Disease","Metastatic Cancer","Adenocarcinoma of the Stomach","Gastroesophageal Junction Adenocarcinoma","Metastatic Adenocarcinoma",[63,561,562,563,564,565,566,567],"GEJ Cancer","oligometastasis","limited metastatic","hypofractionated radiotherapy","immunotherapy","gastrectomy","metastasectomy","2023-11-07",{"date":570,"type":37},"2023-11-08",{"date":572,"type":37},"2023-01-01",{"date":574,"type":19},"2027-12-31",{"name":576,"class":76},"Fudan University",{"id":578,"slug":4,"hasResults":10,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":220,"enrollmentInfo":584,"targetDuration":4,"studyType":20,"phases":586,"briefSummary":587,"conditions":588,"keywords":593,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":77},"100477215","NCT05494060","XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma","XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial","EXPLORING","Inclusion Criteria:\n\n* Subjects aged ≥18 and ≤75 years old, male or female.\n* ECOG performance status score 0-1.\n* Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.\n* Pathological stage:III (8th AJCC TNM).\n* Estimated lifetime is greater than 6 months.\n* The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:\n\n  1. Routine blood test:\n\n     1. Hemoglobin (HB) ≥90 g\u002FL.\n     2. Neutrophil count (ANC) ≥1.5×109\u002FL.\n     3. Platelet count (PLT) ≥100×109\u002FL.\n  2. Biochemical test:\n\n     1. Total bilirubin≤1.5×ULN (upper limit of normal).\n     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.\n     3. Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL\u002Fmin.\n* No obvious clinical symptoms of heart disease.\n* Must have disease-free status documented by complete physical examination and imaging studies with no evidence of recurrent, residual, or metastatic disease on standard imaging (chest, abdomen, and pelvis captured by CT chest and CT or MRI of abdomen and pelvis) per investigator assessment within 28 days prior to enrollment.\n* Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control (Appendix 9) for the duration of the study, and ≥ 120 days after the last dose of penpulimab and 180 days after the last dose of chemotherapy.\n* Volunteer to participate in this study and sign an informed consent form.\n* Considering that NGS analysis may take up to 10 working days, patients could receive 1 cycle of XELOX chemotherapy after ctDNA sampling.\n\nExclusion Criteria:\n\n* Participation in other drug clinical trials within four weeks.\n* Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.\n* History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.\n* Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.\n* Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF ≥ 450 ms in men, ≥ 470 ms in women requiring long-term use of antiarrhythmic drugs and New York Heart Association Class ≥ II cardiac insufficiency;There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.\n* Long-term unhealed wound or unhealed fracture.\n* Imaging findings show that the tumor has invaded around important blood vessels or the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage as judged by the investigator.\n* Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before randomization: INR is within normal range without anticoagulants or has no clinically significant abnormality); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients with prothrombin time international normalized ratio (INR) ≤ 1.5 are allowed to take low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (the daily dose does not exceed 100 mg) for preventive purposes.\n* Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been judged by the investigator to have recovered) and pulmonary embolism.\n* Urine routine showed urine protein and 24 h urine protein was confirmed to be \\> 1.0g.\n* Previous use of immune targeted therapy drugs.\n* History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* Patients with infectious pneumonia, pneumonitis, interstitial pneumonia and other conditions requiring corticosteroids.\n* History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, irritable bowel syndrome and other chronic diarrheal diseases; history of sarcoidosis or tuberculosis; history of active hepatitis B, C and HIV infection; well-controlled non-serious immune diseases, such as dermatitis, arthritis, psoriasis, etc. Hepatitis B virus \\\u003C 1000 copies\u002Fml can be detected.\n* Patients with hypersensitivity to human or murine monoclonal antibodies.\n* Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders.\n* Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention.\n* Patients who do not follow the doctor's advice, do not take medicine as required, or have insufficient data that can affect the efficacy judgment or safety judgment.\n* Patients with concomitant diseases that, in the judgment of the investigator, seriously jeopardize the patient's safety or affect the patient's completion of the study.",{"count":585,"type":19},80,[89],"This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks\u002Fcycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.",[589,590,252,146,591,25,592],"Carcinoma","Gastrointestinal Diseases","Digestive System Diseases","Gastrointestinal Neoplasms",[594,595,596,597,598,599],"Penpulimab","Anlotinib","Capecitabine","Oxaliplatin","ctDNA","adjuvant therapy","2023-11-03",{"date":568,"type":37},{"date":603,"type":37},"2022-03-16",{"date":605,"type":19},"2027-02",{"name":607,"class":76},"The First Affiliated Hospital with Nanjing Medical University",{"id":609,"slug":4,"hasResults":10,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":220,"enrollmentInfo":614,"targetDuration":4,"studyType":20,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100492070","NCT05687357","Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G\u002FGEJ Adenocarcinoma","Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial","Inclusion Criteria:\n\n1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3\\~4aN+M0 or T4bNanyM0 （AJCC Version 8）\n2. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1\n3. Has adequate organ function.\n4. Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.\n5. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.\n\nExclusion Criteria:\n\n1. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.\n2. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.\n3. Has an active infection requiring systemic therapy.\n4. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n5. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.\n7. Has an active autoimmune disease that has required systemic treatment in past 2 years.\n8. Has a known history of human immunodeficiency virus (HIV) infection.\n9. Has a known history of Hepatitis B or known active Hepatitis C virus infection (HBsAg positive with HBV DNA≥500 IU\u002Fml；HCV：HCV antigen positive with HCV copies \\>ULN).\n10. Has had an allogenic tissue\u002Fsolid organ transplant.\n11. Has received a live vaccine within 30 days prior to the first dose of study treatment.\n12. Female participants who are breastfeeding.",{"count":615,"type":19},140,[89],"The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.\n\nThe primary study hypotheses are that:\n\nNeoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.",[25,146],"2023-04-17",{"date":621,"type":37},"2023-04-19",{"date":623,"type":37},"2023-03-15",{"date":625,"type":19},"2027-08-31",{"name":627,"class":76},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",3,{"id":630,"slug":4,"hasResults":10,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":375,"enrollmentInfo":635,"targetDuration":4,"studyType":20,"phases":636,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":231,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":4},"100473618","NCT05447234","TCRx_T Cells for Advanced or Recurrent Gastric\u002FGastroesophageal Junction Cancer After Failure of First Chemotherapy","Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric\u002FGastroesophageal Junction Cancer After Failure of First Chemotherapy","Inclusion Criteria:\n\n1. Age 18-70 years old;\n2. Histologically confirmed advanced\u002Flocally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric\u002Fgastroesophageal junction surgery combined with neoadjuvant\u002Fadjuvant chemotherapy\n3. Expected survival time ≥ 3 months\n4. Eastern Cooperative Oncology Group (ECOG) score 0-2\n5. According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)\n6. Normal bone marrow hematopoietic function: (leukocytes≥4000 cells\u002F㎕, neutrophils≥1500 cells\u002F㎕, platelet counts≥100000 cells\u002F㎕)\n7. Normal liver and kidney function: serum bilirubin \\\u003C1.5mg\u002Fdl, AST (SGOT) and ALT (SGPT) \\\u003C2.5UNL, alkaline phosphatase \\\u003C5UNL; serum creatinine \\\u003C1.5mg\u002Fdl;\n8. Men and women must take appropriate contraceptive measures.\n\nExclusion Criteria:\n\n1. Patients with previous non-gastric\u002Fgastroesophageal junction malignant tumor\n2. History of severe acute allergy\n3. There is an uncontrolled infection\n4. History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis\n5. History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)\n6. History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure\n7. Poor control of hypertension\n8. QT interval \\>480ms\n9. Evidence of active bleeding or bleeding tendency\n10. Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation\n11. Grade 3 or 4 diarrhea\n12. Any serious and\u002For unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures\n13. Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration\n14. Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish\n15. Any persistent toxicity greater than grade 1 and\u002For worsening in severity from prior anticancer therapy, except for alopecia\n16. Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study\n17. Pregnant or lactating women\n18. Men or women planning to become pregnant within the next six months",{"count":166,"type":19},[637],"EARLY_PHASE1","To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric\u002Fgastroesophageal junction cancer after failure of first chemotherapy.",[25,146],[641,25,146],"T Cell Receptor","2023-02-14",{"date":644,"type":37},"2023-02-16",{"date":646,"type":19},"2023-03-01",{"date":648,"type":19},"2028-03-01",{"name":650,"class":76},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":652,"slug":4,"hasResults":10,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":20,"phases":658,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":667,"locationsCount":77},"100473061","NCT05439993","Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma","A Phase 1b\u002F2 Study of Tepotinib in Combination With Paclitaxel in Patients With MET Amplified or MET Exon 14 Alterated Advanced Gastric and Gastroesophageal Junction Carcinoma","Inclusion Criteria:\n\n1. Have the willingness to sign a written informed consent document prior to any study specific precedures\n2. Age ≥ 19 years of male and female\n3. At each phase of the trial, subjects who meet the following requirements in the appropriate phase will be enrolled.\n\n   A. Phase 1b: Subjects with a histologically confirmed metastatic solid tumor that have progressed after treatment with approved therapies or for which there is no standard effective therapy available.\n\n   B. Phase 2b: Subjects with histologically confirmed locally advanced or metastatic gastric and gastroesophageal carcinoma that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy, with MET amplified (copy number gain ≥3) or MET exon 14 skipping mutation in the archival or fresh tumor tissue specimen identified in study customized targeted DNA deep sequencing (NGS by gastric cancer panel). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.\n4. Patients must have measurable disease based on RECIST 1.1 (Phase 2 part only) Measurable disease will not be required for enrollment in the phase1b part. Patients with evaluable lesion only (without measurable lesion) can be enrolled in the phase 1b part.\n5. ECOG performance status 0-1\n6. Patients must have adequate organ and marrow function as defined below:\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) lesions (ie, those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without evidence of CNS disease progression for more than 4 weeks. However, patients with a leptomeningeal metastasis are excluded.\n2. Treatment with any of the following:\n\n   * Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment\n   * Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subejct can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last does.\n   * Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment. If acute symptoms of radiation have fully resolved, the extent and timing of radiotherapy for eligibility can be discussed between the local investigator and principal investigator.\n   * Any previous exposure to a c-MET inhibitor\n3. History of allogeneic bone marrow transplantation or organ transplantation\n4. History of another primary cancer (excluding gastric cancer):\n5. Clinically significant cardiovascular disease including but not limited to:\n\n   * Acute coronary syndome within the 6 months prior to the initiation of study drug (including myocardial infarction or unstable angina, Coronary Artery Bypass Graft surgery, percuatneous coronary intervention and stenting)\n   * Current heart failure or past history of heart failure\n   * Left ventricle ejection fraction (LVEF) \\\u003C 50%; if there is no past history of heart failure, screening with echocardiography to confirm EF is not required.\n   * Current or past history of clinically significant cardiac arrhythmia (eg, complete left bundle branch block, third degree heart block)\n   * Any risk factors that prolong QTc or increase the probability of arrhythmia, including medication (eg: heart failure, hypokalemia, congenital long QT syndrome, history of Torsades de Pointes)\n6. Persistent uncontrolled hypertension as defined by: systolic \\>180 mmHg or diastolic \\>100 mmHg despite medical treatment\n7. Seropositivity of HIV or known active hepatitis B and\u002For active hepatitis C infection. Hepatitis B carriers may be enrolled if prophylactic use of an antiviral agent with minimal interaction with CYP3A4 is administered to inhibit HBV activation (eg. Entecavir, adefovir)\n8. Impairment of gastrointestinal function or gastrointestinal disorders (eg. untreated ulcerative disorders; uncontrolled nausea, vomiting, or diarrhea; absorption disorder syndrome; small bowel resection; ileostomy). Patients with ileostomcy will not allowed to be enrolled, but patients with colostomy can be enrolled to this study.\n9. As judged by the Investigator, all other symptoms and associated disease for which the investigator determined that participation in this study is contraindicated (e.g. Infection\u002Finflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; unable to swallow oral pills; social and psychological problems, etc)\n10. Pregnant or lactating women. Pregnancy is defined as the state from conception confirmed by HCG clinical laboratory test to termination of pregnancy.\n11. Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial\n12. Hypersensitivity to paclitaxel",{"count":248,"type":19},[88,89],"Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced gastric and gastroesophageal junction carcinomas (AGC\u002FGEJCs) with MET amplification or MET exon 14 alterations. This study is devided into Phase 1b and Phase 2 study.",[25,146],"2022-06-29",{"date":663,"type":37},"2022-07-05",{"date":665,"type":37},"2022-03-01",{"date":461,"type":19},{"name":668,"class":76},"Hallym University Medical Center",""]