[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-adenocarcinoma":671},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,53,0,25,[9,43,90,117,140,165,192,212,239,278,301,330,357,376,398,423,448,469,485,502,525,568,594,619,647],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100054289",false,"NCT06732388","Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus","Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-risk Barrett's Esophagus in Combination With Ablation","Inclusion Criteria:\n\n* Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.\n\n  * Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed\n* Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \\\u003C 18 years of age, children are excluded from this study\n* Clinically eligible for EGD and endoscopic treatment of BE\n* Absolute neutrophil count ≥ 1,000\u002Fmicroliter\n* Platelets ≥ 100,000\u002Fmicroliter\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (≤ 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional upper limit of normal\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use one or more methods of highly effective contraception that do not contain estrogen (e.g. progestin only oral contraceptive, non-hormonal intrauterine device, bilateral tubal ligation) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Women should not donate eggs or participate in in vitro fertilization for the duration of study participation, and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Male subjects should avoid donating sperm, and if engaged in intercourse with women of child-bearing potential use a method of highly effective contraception.\n\n  * Activities of Reproductive Potential: In addition to heterosexual intercourse, activities that could lead to pregnancy (e.g. sperm or egg donation, participation in in vitro fertilization) should be considered when evaluating the reproductive potential of clinical trial subjects.\n  * Females of Reproductive Potential: A non-post-menopausal female who has not had a bilateral oophorectomy or medically documented ovarian failure. A female who has had a tubal ligation sterilization, or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g. egg donation, participation in in vitro fertilization).\n  * Menopause:\n\n    * Twelve (12) months of spontaneous amenorrhea or;\n    * Spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \\> 40 mIU\u002FmL or;\n    * Subject is post-bilateral oophorectomy with or without hysterectomy\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure\n* Prolonged corrected QT (QTc) (\\> 450 ms for men and \\> 470 ms for women)\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole\n* Uncontrolled intercurrent illness., or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole\n* Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and\u002For in collaboration with a clinical pharmacist.\n\n  * Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial\n* History of eosinophilic esophagitis\n* History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly\n* Participants must not have evidence of active\u002Frecurrent invasive cancer of a non-esophageal organ\n* Participants with EAC greater than stage T1a\n* Persistent (\\> 24 hour \\[h\\]) systolic blood pressure (BP) greater than or equal to 160 mmHg (to avoid reaching hypertensive crisis defined as systolic BP \\> 180 mmHg)\n* Patients taking eliglustat. Co-administration of itraconazole and eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of CYP2D6","ALL","18 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.",[26,27,28,29],"Barrett Esophagus","Clinical Stage I Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8","Esophageal Adenocarcinoma","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-06-23",{"date":38,"type":20},"2030-12-01",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",6,{"id":44,"slug":4,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":70,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100644985","NCT07675967","Clonal Hematopoiesis Chemotherapy and Radiation Effects Study","CH CARE","Inclusion Criteria:\n\n* Participants to be included in this study include the following:\n* Adults age \\>18 years\n* Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)\n* Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).\n* Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.\n\nExclusion Criteria:\n\n* Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure\n* Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)\n* Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.",{"count":50,"type":20},5000,"OBSERVATIONAL","The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers.\n\nThe study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs).\n\nUltimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.",[54,55,56,57,58,59,60,61,62,63,64,29,65,66,67,68,69],"Lung Cancer (Diagnosis)","Osteochondroma","Spitz Nevus","Solid Cancers","Breast Cancer","Gastric (Stomach) Cancer","Colorectal (Colon or Rectal) Cancer","Sarcoma","Ovarian Adenocarcinoma","Uterine Adenocarcinoma","Endometrial Adenocarcinoma","Head and Neck Cancer","Therapy-Related Acute Myeloid Leukemia","Therapy-Related MDS","Clonal Hematopoiesis of Indeterminate Potential (CHIP)","Clonal Cytopenia of Undetermined Significance",[71,72,73,74,75,76,77,78],"Adult cancer survivors","Precursor Lesions","clonal hematopoiesis","chemotherapy","radiation","therapy-related myeloid neoplasms","CCUS","clonal hematopoiesis of indeterminate potential","2026-06-29",{"date":81,"type":34},"2026-06-30",{"date":83,"type":34},"2025-04-04",{"date":85,"type":20},"2035-03-31",{"name":87,"class":88},"Dana-Farber Cancer Institute","OTHER",1,{"id":91,"slug":4,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100480004","NCT05530343","Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance","A Multicenter Randomized Trial of Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance (The SWAT-BE Study)","SWAT-BE","Inclusion Criteria:\n\nSurveillance Population\n\n* Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's esophagus (NDBE, based on last endoscopic procedure; patients with prior history of low-grade dysplasia\u002Findefinite for dysplasia with NDBE at last endoscopy can be included)\n* Barrett's esophagus (BE) length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age18-89 years\n* Life-expectancy of at least 2 years\n\nScreening Population\n\n* Undergoing endoscopy for screening of BE\n* BE length of at least M1\n* English and Spanish speaking\n* Able to comprehend and complete the consent form\n* Age 18-89 years\n* Expected life-expectancy of at least 2 years\n\nPhysicians\n\n-All participating sites will include physicians who are trained in the use of WATS3D and certified by the site PI. All endoscopists will need to complete a minimum of three cases to be eligible to participate in the study.\n\nExclusion Criteria:\n\nSurveillance Population\n\n* BE patients undergoing surveillance or evaluation for endoscopic eradication therapy (EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC)\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of EET\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy\n\nScreening Population\n\n* BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC\n* Active erosive esophagitis with LA Grade B or higher\n* Esophageal varices\n* Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication\n* Pregnancy","89 Years",{"count":99,"type":20},2298,[101],"NA","The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).\n\nBarrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer.\n\nEndoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.\n\nPatients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).\n\nPatients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE.\n\nWhile both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other.\n\nParticipants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized.\n\nUp to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.",[26,104,29],"Barretts Esophagus With Dysplasia",[106,29,107],"Barrett's Esophagus","Dysplasia",{"date":109,"type":34},"2026-07-01",{"date":111,"type":34},"2022-10-03",{"date":113,"type":20},"2026-06",{"name":115,"class":88},"University of Colorado, Denver",14,{"id":118,"slug":4,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100608825","NCT07206589","Minimally Invasive Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Cancer, SOS5C Trial","Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma- R01 Aim 1a Renewal (SOS5C Trial)","Inclusion Criteria:\n\n* SPECIFIC AIM 1A: Adult patients 18-85 years old\n* SPECIFIC AIM 1A INTERVENTION CLUSTERS: BE Risk Tool Score \\> 0.087, indicating a higher risk for BE\u002Fesophageal adenocarcinoma (EAC). This will be run as a web-based application integrating data from several domains in the electronic health record (EPIC). Output score will range from 0-1.\n* SPECIFIC AIM 1A CONTROL CLUSTERS: Meeting American College of Gastroenterology (ACG) screening criteria (gastroesophageal reflux disease \\[GERD\\]+ \\> 2 BE risk factors: Age ≥ 50 years, Male sex, Caucasian race, obesity \\[body mass index (BMI) \\> 30\\], ever smoker, family history of BE\u002FEAC)\n* SPECIFIC AIM 1B: A \"low risk\" BE risk tool score (\\\u003C 0.0897)\n\nExclusion Criteria:\n\n* SPECIFIC AIM 1A: History of Barrett's esophagus or esophageal adenocarcinoma\n* SPECIFIC AIM 1A: Prior endoscopy in the last 10 years\n* SPECIFIC AIM 1A: Patients who are unable to consent\n* SPECIFIC AIM 1A: Patients with a current history of uninvestigated dysphagia\n* SPECIFIC AIM 1A: History of eosinophilic esophagitis, achalasia\n* SPECIFIC AIM 1A: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to the sponge procedure\n* SPECIFIC AIM 1A: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to the sponge procedure\n* SPECIFIC AIM 1A: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to the sponge procedure\n* SPECIFIC AIM 1A: Patients with a history of known varices or cirrhosis\n* SPECIFIC AIM 1A: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma\n* SPECIFIC AIM 1A: Patients with congenital or acquired bleeding diatheses\n* SPECIFIC AIM 1A: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma\n* SPECIFIC AIM 1A: Patients with limited life expectancy (\\\u003C 2 years): per provider judgement\n* SPECIFIC AIM 1B: History of Barrett's esophagus or esophageal adenocarcinoma\n* SPECIFIC AIM 1B: Prior endoscopy in the last 10 years\n* SPECIFIC AIM 1B: Patients who are unable to consent\n* SPECIFIC AIM 1B: Patients with a current history of uninvestigated dysphagia\n* SPECIFIC AIM 1B: History of eosinophilic esophagitis, achalasia\n* SPECIFIC AIM 1B: Patients on oral anticoagulation including Coumadin, Warfarin unless discontinued for five days prior to procedure\n* SPECIFIC AIM 1B: Patients on antiplatelet agents including Clopidogrel, unless discontinued for five days prior to procedure\n* SPECIFIC AIM 1B: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban, and edoxaban, unless discontinued for five days prior to procedure\n* SPECIFIC AIM 1B: Patients with a history of known varices or cirrhosis\n* SPECIFIC AIM 1B: Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma\n* SPECIFIC AIM 1B: Patients with congenital or acquired bleeding diatheses\n* SPECIFIC AIM 1B: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma\n* SPECIFIC AIM 1B: Patients with limited life expectancy (\\\u003C 2 years): per provider judgement",true,"85 Years",{"count":126,"type":20},1010,[101],"This clinical trial studies how well minimally invasive approaches (an artificial intelligence \\[AI\\] powered risk tool, nurse navigation, and a sponge on a string \\[SOS\\] test) work in diagnosing patients with Barrett's esophagus (BE) and esophageal cancer. Esophageal cancer has a poor 5-year survival rate when diagnosed after onset of symptoms. While rising, incidence of esophageal cancer remains too low to screen the entire population. BE is a condition in which the cells lining the lower part of the esophagus have changed or been replaced with abnormal cells that could lead to esophageal cancer. Currently, patients are screened for BE based on certain risk factors (reflux, age \\> 50 years, White race, family history of esophageal cancer, obesity, male sex, and smoking), followed by endoscopies and surgery for treatment. These standard procedures may result in under-recognition of BE risk due to inaccurate and difficult to use risk assessment tools, high cost, invasiveness, low access to endoscopy, and sub-optimal recognition of abnormal cells during routing endoscopy. An AI powered risk tool that integrates symptoms, health history, and laboratory values from electronic health record data may more accurately assess BE and esophageal cancer risk that manual assessment. The BE-SOS screening test combines a swallowable cell collection device with assessment of DNA, which may more accurately diagnose abnormal cells. Nurse navigation involves trained personnel assisting individuals through the screening process and completing the follow-up diagnostic test if the screening test is positive. Navigators address cultural, social, access, and logistical barriers to screening. Nurse navigation may increase completion rates of diagnostic procedures following a positive screening test. These minimally invasive approaches may enable higher rates of BE screening than currently being accomplished.",[26,29],"NOT_YET_RECRUITING",{"date":132,"type":34},"2026-06-24",{"date":134,"type":20},"2026-12-01",{"date":136,"type":20},"2030-07-31",{"name":138,"class":88},"Mayo Clinic",3,{"id":141,"slug":4,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":164},"100541015","NCT06324357","Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread","Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)","Inclusion criteria:\n\n* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)\n* Cohorts A to K and Cohort O: Documented Human epidermal growth factor receptor 2 overexpressing and\u002For amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).\n* Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression\u002Famplification according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) gastric cancer guidelines and according to the result of local testing.\n* For dose optimization and justification (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue\n* History of prior treatment lines in palliative setting:\n\n  * For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K and O documented investigator assessed progression after HER2-directed treatment for unresectable locally advanced or metastatic disease (For Cohorts D, H, I (I-ext), J (J-ext) - patients must have been pretreated with trastuzumab deruxtecan (T-DXd) and have progressed or have been intolerant to previous T-DXd).\n  * For cohorts L, L-ext, M and N documented progression or recurrence of disease during or following their latest line of therapy. Patients must have had at least one prior line of therapy for locally advanced unresectable disease or metastatic disease (adjuvant and neoadjuvant therapy excluded) and documented disease progression or recurrence of disease during or following their latest line of therapy. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.\n* Presence of at least one measurable lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Previous treatment with:\n\n  * Any small molecule HER2 inhibitor in the palliative setting in Cohorts D, E, F, H, L, L-ext, M, and N. In Cohort D allowed in up to 15 patients in each dose level (DL).\n  * T-DXd in Cohorts E and F. In Cohort E allowed in up to 15 patients in each DL.\n  * trastuzumab emtansine (T-DM1) in the palliative setting in Cohort D and H. In Cohort H allowed in up to 15 patients in each DL.\n  * Capecitabine in Cohort D and H. In Cohort D allowed in up to 15 patients in each DL\n* Presence of uncontrolled and\u002For symptomatic brain metastases, or leptomeningeal disease\n* Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \\>470 msec.\n* Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.\n* Ejection fraction \\\u003C50% or the lower limit of normal of the institutional standard within 28 days prior to randomization\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.",{"count":147,"type":20},768,[149,23],"PHASE1","This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.\n\nIn this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.\n\nDuring the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT\u002FMRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.",[152,153,154,29,155],"Metastatic Breast Cancer","Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Colorectal Cancer",{"date":132,"type":34},{"date":158,"type":34},"2024-06-03",{"date":160,"type":20},"2029-01-08",{"name":162,"class":163},"Boehringer Ingelheim","INDUSTRY",108,{"id":166,"slug":4,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":89},"100641907","NCT07660627","Determining Minimal Residual Disease Using ctDNA Deep Sequencing","Determination of Minimal Residual Disease by Deep ctDNA Sequencing.","CIT-SEQ","Inclusion Criteria:\n\n* Consent to participate in the study\n* Patients with esophageal, gastric, or pancreatic cancer, stage 0-2\n* Patients with locally advanced, potentially operable disease treated with systemic perioperative chemotherapy or chemoradiotherapy\n* Patients with metastatic disease treated with first- to third-line palliative systemic therapy\n\nExclusion Criteria:\n\n* not specified",{"count":173,"type":20},34,[101],"Preoperative neoadjuvant chemotherapy is the standard treatment for locally advanced gastrointestinal tumours. However, not all patients respond to preoperative treatment. Early identification of progression during neoadjuvant chemotherapy or diagnosis of early disease relapse during adjuvant treatment is essential to modify the treatment strategy. The aim of this project is to validate ctDNA as a biomarker of molecular relapse\u002Fprogression of disease.",[29,177,178],"Gastric Cancer","Pancreatic Cancer",[180,181,182,183],"Minimal residual disease","NGS sequencing","gastrointestinal tumors","Preoperative neoadjuvant chemotherapy","2026-06-19",{"date":132,"type":34},{"date":187,"type":34},"2022-08-22",{"date":189,"type":20},"2026-12-31",{"name":191,"class":88},"Masaryk Memorial Cancer Institute",{"id":193,"slug":4,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":89},"100374067","NCT04150640","Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma","Phase 2 Trial of 5-Fluorouracil, Oxaliplatin and Liposomal Irinotecan and Immunotherapy (Plus Trastuzumab for HER2-positive Disease) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma","Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information.\n\nNOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS status prior to treatment initiation.\n* Measurable disease according to RECIST v1.1.\n* No prior lines of systemic therapy for advanced disease.\n* Participants who had received neoadjuvant or adjuvant therapy or definitive chemoradiation will be allowed to participate if recurrence occurred 6 months or longer from the completion of all prior treatments.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to registration\n\n  * Absolute Neutrophil Count (ANC) ≥1,500 \u002Fμl without the use of hematopoietic growth factors\n  * Hemoglobin (Hgb) ≥8 g\u002FdL (blood transfusions are permitted for participants with hemoglobin levels below 8 g\u002FdL)\n  * Platelets ≥100,000 \u002Fμl\n  * Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl calculation using the Cockcroft-Gault formula. ≥50 mL\u002Fmin for participants with creatinine levels \\> 1.5 X institutional ULN\n  * Bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); abnormal bilirubin (≤1·5 × upper limit of normal (ULN)) is allowed for patients with Gilbert's disease\n  * Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Women of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n* Women of childbearing potential and males must be willing to abstain from heterosexual activity or to use a form of effective method of contraception from the time of informed consent until 30 days after treatment discontinuation.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products.\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrollment).\n* Other active malignancy requiring treatment within the last 2 years. Exceptions include subjects with non-melanoma skin cancer, non-invasive\u002Fin situ cancer or low-risk prostate cancer requiring hormonal therapy only.\n* Current therapy with other investigational agents or participation in another clinical study (supportive care and nontherapeutic trial participation allowed if not receiving an investigational drug). Participants may participate in prescreening for other therapeutic trials (prescreening of biologic sample for specific mutations, receptors, etc.)\n* Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement).\n* Radiotherapy less than 7 days prior to the start of the study treatment\n* Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should not have any contraindications to immune checkpoint inhibitors and should not have received immunotherapy agents for the treatment of EGA prior to study enrollment.\n\n  * Participants must not have active autoimmune disease that has required systemic treatment in the past 2 years. Participants are permitted to receive immunotherapy l if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).\n  * Participants must not have a condition requiring systemic treatment with either corticosteroids (\\>10 mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of study immunotherapy administration. Inhaled or topical steroids and adrenal replacement doses (≤10 mg\u002Fday prednisone equivalent) are permitted. Participants with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents.\n* Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Active infection requiring systemic therapy.\n* Pregnant or breastfeeding.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.\n* Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.\n* NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.\n* Known history of Human Immunodeficiency Virus (HIV).",{"count":199,"type":20},52,[23],"This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.",[29,203],"Gastric Adenocarcinoma","2026-06-18",{"date":36,"type":34},{"date":207,"type":34},"2020-07-13",{"date":209,"type":20},"2028-05",{"name":211,"class":88},"University of Wisconsin, Madison",{"id":213,"slug":4,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":229,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":89},"100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":219,"type":20},72,[23],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[223,224,225,226,203,227,29,228],"Melanoma","NSCLC","Hepatocellular Carcinoma","Urothelial Cancer","HNSCC","Microsatellite Instability-High Solid Malignant Tumor",[230,231],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)",{"date":36,"type":34},{"date":234,"type":34},"2020-09-14",{"date":236,"type":20},"2032-04-30",{"name":238,"class":88},"Dan Zandberg",{"id":240,"slug":4,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":259,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":89},"100614693","NCT07282912","Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","OLIGOMETS","Inclusion Criteria:\n\n* Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.\n\n  a) All participants must have confirmed histologic diagnosis of the primary tumor, which may be confirmed retrospectively by a radiologist if necessary.\n* Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo\u002Fradioembolization (cholangiocarcinomas).\n* Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:\n\n  1. Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative radiation\u002Fablative therapy\n  2. Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments), wedge resection requiring a minimum of 40% of liver parenchyma following resection based on future liver remnant or a combination of partial hepatectomy and microwave ablation or trans-arterial radioembolization (TARE).\n  3. Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites) (see Appendix 3).\n  4. Resectable peritoneal disease with a PCI of ≤6 and the ability to obtain a CC0 cytoreduction.\n  5. Distant metastasis must be limited to two of the above-mentioned sites (a-d).\n  6. If both pulmonary and liver metastasis are present (a, b), then a total of five lesions will be considered oligometastatic.\n* Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.\n* Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.\n* Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.\n* Patients must have at least 4 months of prior effective systemic therapy.\n* Has hemoglobin ≥ 8 g\u002FdL.\n* Has ANC ≥ 1500\u002FuL.\n* Has platelet count ≥ 75000\u002FuL.\n* Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n* Has aspartate aminotransferase (AST) \\& alanine aminotransferase (ALT) ≤ 5 times ULN.\n* Has creatinine clearance ≥ 50 mL\u002Fmin.\n* Patient who is at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score 0-1 (see Appendix 6) at the time of randomization.\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence) during the treatment period and for at least 95 days following completion. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the participant may participate in the main study without participating in the FBR.\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nNote: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* Has developed progressive disease on current line of systemic therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past three years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known CNS metastasis and\u002For carcinomatous meningitis.\n* Has known osseous metastasis.\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.\n* Has histologic subtypes not included in the inclusion criteria (including esophageal squamous cell carcinoma, gastroenteropancreatic neuroendocrine tumors, hepatocellular carcinoma, etc.).\n* Has a primary tumor that is not amenable to the treatment modalities listed in section 3.\n* Has albumin level less than 3.0 g\u002FdL despite appropriate nutritional support. Diagnostic Assessments\n* Has detectable ctDNA at the time of enrollment.\n* Has an active infection requiring systemic therapy.\n* Has known active TB\u002FCOVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.\n* Inability to receive chemotherapy and\u002For surgery and\u002For radiotherapy and\u002For ablative procedures due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.","80 Years",{"count":248,"type":20},54,[23],"This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.",[252,29,253,203,254,255,256,257,258],"Foregut Adenocarcinoma","Gastroesophageal Adenocarcinoma","Pancreas Adenocarcinoma","Duodenal Adenocarcinoma","Ampullary Adenocarcinoma","Gallbladder Adenocarcinoma","Intra - and Extrahepatic Cholangiocarcinoma",[260,261,262,263,264,265,266,267,268],"Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Oligometastasis","Esophageal adenocarcinoma","Gastroesophageal adenocarcinoma,","Gastric adenocarcinoma","Duodenal adenocarcinoma","Pancreatic\u002Fampullary adenocarcinoma","Gallbladder adenocarcinoma","Intra- and extrahepatic cholangiocarcinoma.","2026-06-17",{"date":271,"type":34},"2026-06-22",{"date":273,"type":34},"2026-06-02",{"date":275,"type":20},"2028-06",{"name":277,"class":88},"Yale University",{"id":279,"slug":4,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":283,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":285,"conditions":286,"keywords":291,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":299,"locationsCount":42},"100616775","NCT07309991","Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy","Inclusion Criteria:\n\n* Patients diagnosed with esophageal carcinoma or benign esophageal tumors\n* Patients requiring surgical resection of the lesion with subsequent esophageal reconstruction\n* Patients must have had at least one postoperative arterial blood gas analysis\n* Patients must have routinely undergone at least one of the following for postoperative evaluation of the anastomosis: endoscopy, CT scan, or esophagram\n\nExclusion Criteria:\n\n* Patients who did not require esophageal reconstruction\n* Patients undergoing esophageal replacement with colon\n* Patients with incomplete data",{"count":284,"type":20},2500,"This study aims to determine whether postoperative hypoxia (arterial partial pressure of oxygen (PaO₂)\\\u003C80 mmHg) is an independent risk factor for anastomotic leakage after esophagectomy. The investigators conducted a retrospective analysis of cases from their center over the past five years, stratifying patients into Low Pa0₂ Group and Normal Pa0₂ Group based on postoperative oxygen levels and comparing the incidence of anastomotic leakage between the groups. The goal is to establish whether hypoxia is a causative risk factor and whether correcting it can reduce the risk of anastomotic leakage.",[287,29,288,289,290],"Esophageal Carcinoma","Esophagectomy","PaO2","Esophageal Anastomotic Leakeage",[292],"Effect of Postoperative PaO₂ on Anastomotic Leakage Following Esophagectomy","2026-06-13",{"date":295,"type":34},"2026-06-16",{"date":297,"type":34},"2021-01-01",{"date":134,"type":20},{"name":300,"class":88},"Sun Yat-sen University",{"id":302,"slug":4,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"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":308,"type":20},840,[23,310],"PHASE3","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.",[313,314,315,29],"Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma","Metastatic Gastric Cancer","Gastroesophageal Junction Cancer",[317,318,319],"gastric cancer","gastroesophageal junction cancer","esophageal adenocarcinoma","2026-06-10",{"date":322,"type":34},"2026-06-12",{"date":324,"type":34},"2026-05-14",{"date":326,"type":20},"2032-07-21",{"name":328,"class":163},"Pfizer",71,{"id":331,"slug":4,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100614791","NCT07284186","First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, relapsed\u002Frefractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies\n* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function\n* Measurable disease per RECIST 1.1\n* ECOG PS of 0 or 1\n\nKey Exclusion Criteria:\n\n* Germline SMARCA4 mutations\n* Known SMARCA2 mutation or loss of expression\n* Symptomatic CNS disease\n* Prior treatment with another SMARCA2-directed therapy\n* History of other malignancies\n* Clinically significant heart disease\n* Uncontrolled hypertension\n* Prolongation of QT interval",{"count":337,"type":20},155,[149],"A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed\u002Frefractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.\n\nThe study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.\n\nParticipants will receive their assigned dose of PLX-61639 administered orally, once daily until progression\u002Frelapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.",[341,203,342,343,344,345,29,346,347,348],"Esophageal Squamous Cell Carcinoma","Gastric Squamous Cell Carcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma","Metastatic Solid Tumor","Non-Small Cell Lung Carcinoma","SMARCA4 Mutation","Gastroesophageal Junction Squamous Cell Carcinoma","Advanced Solid Tumor",{"date":322,"type":34},{"date":351,"type":34},"2025-12-01",{"date":353,"type":20},"2030-09",{"name":355,"class":163},"Plexium, Inc.",10,{"id":358,"slug":4,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":21,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":89},"100597524","NCT07059611","Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma","Phase II Study of Neoadjuvant RP2 in Combination With Preoperative Flot for Patients With Stage II or Higher, Non-metastatic Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed and clinically staged T2 or higher or node positive, non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n* Patents must be deemed a surgical candidate by a thoracic surgeon, surgical oncologist, or surgeon who is qualified to perform the appropriate surgical procedure based on patient's primary tumor site.\n* Patients must have normal organ and bone marrow function, as defined below, less than or equal to 14 days prior to the initiation of study therapy:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmicroliter\n  * Platelets ≥100,000\u002Fmicroliter\n  * Total bilirubin ≤ the institutional upper limit of normal (ULN).\n  * AST and ALT ≤ 2.5 times the institutional ULN\n  * Serum creatinine ≤ 1.5 times the institutional ULN\n  * Hemoglobin ≥ 9 g\u002FdL\n\nExclusion Criteria\n\n* Has received prior chemotherapy, radiation therapy, or immunotherapy (anti-programmed cell death protein-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) for the current malignancy.\n* Per the investigator, has contraindications to receiving chemotherapy with FLOT.\n* Per the sub-investigator (gastroenterologist) responsible for intra-tumoral injections or the investigator, patient has contraindications to repeated upper endoscopy for intra-tumoral injections. These could include medical conditions that would, per the judgment of the sub-investigator or investigator, inappropriately increase the risk of upper endoscopy.\n* Conditions in which anticoagulant therapies cannot be safely stopped in the periprocedural period or patients on warfarin with a target international normalized ratio (INR) ≥ 2.5 that cannot be temporarily reversed to INR ≤ 1.7.\n* Active significant herpetic infections or prior complications of Herpes simplex virus-1 (HSV-1) infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or intravenous \\[IV\\]) antivirals with known antiherpetic activity (e.g., acyclovir). Note: Patients with sporadic cold sores may be enrolled as long as no active cold sores are present at the time of first dose of study treatment.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed, however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Available COVID-19 vaccines do not contain live virus and are allowed.\n* Has a condition requiring systemic treatment with corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days of first study treatment administration.\n\n  * Inhaled or topical steroids and adrenal replacement doses ≤ 10mg\u002Fday of prednisone equivalents are permitted.\n* Prior organ transplantation including allogeneic stem-cell transplantation.\n* Has a previous or concurrent malignancy. Exceptions include:\n\n  * Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\n  * Prior malignancy has been completely excised or removed and patient has been continuously disease free for \\> 5-years\n* Has a positive test result for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection with hepatitis B or hepatitis C. Testing will be performed as part of screening on the study.\n\n  * Patients with a known history of hepatitis B or hepatitis C that have been effectively treated (with negative HBsAg and HCV RNA) will be eligible for enrollment on this criterion.\n* Has a known history of human immunodeficiency virus (HIV) with detectable viral load. HIV testing will not be performed as part of screening for the study.\n\n  * Patients with known HIV infection with an undetectable viral load and who are on a stable highly active antiviral regimen per the investigator's assessment will eligible to enroll.\n* Has a psychiatric illness, substance use, or other social conditions that, in the judgment of the investigator, would limit compliance with study requirements.",{"count":173,"type":20},[23],"The research study is being conducted to study whether performing injections of a new treatment, called RP2, directly into stomach and esophagus tumors along with standard chemotherapy (called FLOT) is safe and whether it does a better job of killing cancer before surgery compared to chemotherapy alone.",[203,29,154],"2026-06-03",{"date":369,"type":34},"2026-06-05",{"date":371,"type":20},"2026-09-01",{"date":373,"type":20},"2029-11-01",{"name":375,"class":88},"Abramson Cancer Center at Penn Medicine",{"id":377,"slug":4,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100521611","NCT06071845","Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples","Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia","SOS4C","Inclusion Criteria:\n\n* Subjects with known or suspected Barrett's esophagus (BE) (cases)\n\n  * Patients between the ages of 18-90.\n  * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.\n  * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.\n  * Undergoing clinically indicated endoscopy.\n* Subjects without known history of BE (controls)\n\n  * Undergoing clinically indicated diagnostic endoscopy\n\nExclusion Criteria:\n\n* For subjects with or without known evidence of BE (on history or review of medical records)\n\n  * Pregnant or lactating females.\n  * Patients who are unable to consent.\n  * Patients with current history of uninvestigated dysphagia.\n  * History of eosinophilic esophagitis, achalasia.\n  * Patients on oral anticoagulation including Coumadin, Warfarin.\n  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.\n  * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.\n  * Patients with history of known esophageal or gastric varices or cirrhosis.\n  * Patients with history of surgical esophageal resection for esophageal carcinoma.\n  * Patients with congenital or acquired bleeding diatheses.\n  * Patients with a history of esophageal squamous dysplasia.\n  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.\n  * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.","90 Years",{"count":385,"type":20},450,[101],"This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE\u002Fesophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE\u002FEAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE\u002FEAC.",[26,104,389,29],"Barrett's Esophagus Without Dysplasia","2026-05-29",{"date":273,"type":34},{"date":393,"type":34},"2023-10-16",{"date":395,"type":20},"2027-06-01",{"name":138,"class":88},5,{"id":399,"slug":4,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":21,"phases":407,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":89},"100640004","NCT07603375","Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma","A Single-arm Study of Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma","TNT Esophagus","Inclusion Criteria:\n\n* Subject must be able to provide study specific informed consent prior to study entry\n* Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II);\n* Stage II-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition;\n* Complete history and physical examination within 21 days of signing consent;\n* Staging whole-body FDG-PET\u002FCT (fluorodeoxyglucose-positron emission tomography\u002Fcomputed tomography) scan with or without contrast (preferred) or chest\u002Fabdominal (CT with contrast) confirming there is no evidence of metastatic disease must be obtained within 45 days of study enrollment\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0-2\n* Subjects must be appropriate candidates for planned chemoradiation (concurrent carboplatin\u002Fpaclitaxel) and chemotherapy (FLOT, m-FOLFOX-6) as determined by the treating radiation oncologist, medical oncologist, and surgical oncologist.\n* Adequate hematologic, renal, and hepatic function within 14 days of initiation of therapy\n\nExclusion Criteria:\n\n* Cervical esophageal cancers arising 15-18 cm from the incisors.\n* Esophageal squamous cell carcinoma.\n* Patients with T4b disease according to the AJCC 8th Edition.\n* Definitive clinical or radiologic evidence of metastatic disease.\n* Has had prior systemic therapy or radiation therapy for the current diagnosis.\n* Prior thoracic radiotherapy for any reason that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n* Severe, active co-morbidity defined as follows:\n\n  * Active uncontrolled infection requiring IV antibiotics;\n  * Pregnant and\u002For nursing subjects;\n  * HIV positive with CD4 count \\\u003C 200 cells\u002Fmicroliter. Note that subjects who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells\u002Fmicroliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n* Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",{"count":406,"type":20},60,[23],"The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.",[29],[411,412,413,414],"chemoradiation","consolidation chemotherapy","esophageal cancer","non-metastatic esophageal adenocarcinoma","2026-05-27",{"date":390,"type":34},{"date":418,"type":20},"2026-08-01",{"date":420,"type":20},"2034-02",{"name":422,"class":88},"Duke University",{"id":424,"slug":4,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":21,"phases":431,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":139},"100634815","NCT07544589","A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers","A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers","Key Inclusion Criteria:\n\n1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma\n2. Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n4. Aged ≥18 years at time of signing informed consent\n5. Adequate organ function\n\nKey Exclusion Criteria:\n\n1. Previous solid organ or hematopoietic cell transplant\n2. Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy\n3. Known history of hepatitis B or HIV infection\n4. Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment\n5. Known active central nervous system (CNS) metastases\n6. Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis\n7. Active treatment with antiviral agents\n8. History of severe hypersensitivity to fludarabine or cyclophosphamide\n9. Prior therapies\u002Ftreatments with oncolytic viruses or T cell derived cellular therapy",{"count":430,"type":20},66,[149],"This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor \\[CAR\\] T), in adult participants with advanced gastrointestinal (GI) cancers.\n\nThe study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.",[155,203,29,253],[435,436,437,438,439,440],"CAR T","Adenovirus","ABECMA","BCMA","gastrointestinal cancer","CAR-T",{"date":390,"type":34},{"date":443,"type":20},"2026-04",{"date":445,"type":20},"2046-04",{"name":447,"class":163},"Dispatch Biotherapeutics",{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":21,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":89},"100634986","NCT07546812","Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and\u002For Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a validated immunohistochemistry assay, in situ hybridization or other amplification testing.\n* Has had disease progression during or after first line of systemic therapy for advanced or metastatic gastric, GEJ, or EACs, which must have included at least one of the following:\n\n  1. Platinum- and fluoropyrimidine-based chemotherapy.\n  2. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1\u002FPD-L1-based therapy).\n  3. Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Have adequate organ function.\n* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.\n\nKey Exclusion Criteria:\n\n* Active or history of autoimmune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's\u002Fulcerative colitis), celiac disease, or noninfectious enteritis\u002Fcolitis. (Physiologic hormone replacement not considered systemic treatment).\n* History or current noninfectious pneumonitis\u002Finterstitial lung disease, including radiation-induced pneumonitis requiring steroids or active\u002Frecurrent pneumonitis of any etiology.\n* Documented microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease by local polymerase chain reaction (PCR) (microsatellite status) and\u002For informed consent form (ICH) (mismatch repair (MMR)) assay\n* (For Part 2 only) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTCAE) Version 5.0).\n* (For Part 2 only) Known coagulopathy that increases the risk of bleeding, bleeding diatheses. Any other Grade 3 or higher hemorrhage\u002Fbleeding event within 28 days prior to enrollment.\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience\n\n* Prior treatment with DEN or other C-C chemokine receptor 8 (CCR8)-targeted agents.\n* Prior Lonsurf (trifluridine-tipiracil) or paclitaxel (PAC)-based regimens in the first-line setting for advanced\u002Fmetastatic gastroesophageal adenocarcinoma.\n* Any systemic therapy (including investigational) targeting vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) signaling pathways.\n* Anticancer biologic within 4 weeks, orchemotherapy, targeted small molecule, or radiation therapy within 2 weeks prior to enrollment with unresolved adverse events (AE)s (Grade \\>2). (Observational study participants are eligible).\n* Prior allogenic tissue\u002Fsolid organ or stem cell transplantation. (Exception: corneal transplant not requiring systemic immunosuppression is allowed).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":455,"type":20},120,[23],"The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and\u002For metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.\n\nThe primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).",[459,460,29,203],"HER2-negative","Gastroesophageal Junction",{"date":462,"type":34},"2026-05-18",{"date":464,"type":20},"2026-05",{"date":466,"type":20},"2030-01",{"name":468,"class":163},"Gilead Sciences",{"id":470,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":21,"phases":475,"briefSummary":24,"conditions":476,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":42},"100572370","Repurposing Itraconazole for Secondary Prevention of Metaplasia and Primary Prevention of Cancer in Patients With High-Risk Barrett's Esophagus in Combination With Ablation","Inclusion Criteria:\n\n* Participants with history of prior esophagogastroduodenoscopy (EGD) with an established diagnosis of BE ≥ 2 cm with either low-grade dysplasia (LGD) or high-grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC), naïve to treatment, and being considered for ablation.\n\n  * Note: An eligible diagnosis from an EGD outside of the enrollment sites is allowed for inclusion as long as the biopsies have been reviewed by two pathologists. The two pathologists could include a pathologist from the referring site and an institutional pathologist at the local enrolling site, two pathologists from the referring site, or two pathologists from the local enrolling site. The diagnosis between two pathologists has to be concordant regarding the presence of dysplasia or cancer. Discrepant diagnoses will be resolved by a third pathologist, if needed\n* Participants older than 18 years will be enrolled. Because the incidence of BE and related cancer is very low in participants \\\u003C 18 years of age, children are excluded from this study\n* Clinically eligible for EGD and endoscopic treatment of BE\n* Absolute neutrophil count ≥ 1,000\u002Fmicroliter\n* Platelets ≥ 100,000\u002Fmicroliter\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (≤ 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e. Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 1.5 × institutional upper limit of normal\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* There are no controlled data on the effects of itraconazole on the developing human fetus at the recommended therapeutic dose. For this reason and because azoles are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) two months prior to study entry, for the duration of study participation and two months after completing the study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Current New York Heart Association (NYHA) class III or IV congestive heart failure\n* Prolonged corrected QT (QTc) (\\> 450 ms for men and \\> 470 ms for women)\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to itraconazole\n* Uncontrolled intercurrent illness., or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because itraconazole is a class C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with itraconazole, breastfeeding should be discontinued if the mother is treated with itraconazole\n* Critical drug interactions (grades D or higher) with other medications metabolized by cytochrome P450(CYP)3A4 (if the medication cannot be discontinued or switched or dose modified); these decisions will be made on a case-by-case basis by the site investigators in consultation with the treating provider. Drug interactions can be assessed using one of the available on-line resources, for instance, UpToDate or Clinical Formulary and\u002For in collaboration with a clinical pharmacist.\n\n  * Note: If there are potential drug interactions that do not exclude the participant from the study, a brief research note summarizing the decision-making process about potential drug interactions and their management will be required before the participants are enrolled in the trial\n* History of eosinophilic esophagitis\n* History of strictures not allowing passage of the radiofrequency ablation (RFA) assembly\n* Participants must not have evidence of active\u002Frecurrent invasive cancer of a non-esophageal organ\n* Participants with EAC greater than stage T1a",{"count":474,"type":20},64,[23],[26,27,28,29],"2026-05-12",{"date":479,"type":34},"2026-05-13",{"date":481,"type":20},"2026-10-06",{"date":483,"type":20},"2030-02-01",{"name":40,"class":41},{"id":486,"slug":4,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":123,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":21,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":501},"100434584","NCT04939051","Obeticholic Acid for Prevention in Barrett's Esophagus","Inclusion Criteria:\n\n* Known diagnosis of histologically-confirmed BE with either no dysplasia, indefinite for dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and \\>= 2 cm of involvement on endoscopy\n* Adequate Barrett's mucosa, which is defined as at least one sample with \\>= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study\n* Participants are on proton pump inhibitors (PPI) therapy for \\>= 28 days duration\n* Age \\>= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants \\\u003C 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 70%)\n* Hemoglobin \\>= 10g\u002FdL or hematocrit \\>= 30 %\n* Leukocyte count \\>= 3,500\u002Fmicroliter\n* Platelet count \\>= 100,000\u002Fmicroliter\n* Creatinine clearance (calculated if measured is not available) \\>= 30mL\u002Fmin\u002F1.73m\\^2\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 1.5 X institutional upper limit of normal (ULN)\n* Total bilirubin =\\\u003C 1.0 X ULN\n* Alkaline phosphatase =\\\u003C1.5 X ULN\n* Gamma-glutamyl transferase (GGT) =\\\u003C 1.5 X ULN\n* The effects of OCA on the developing human fetus are unknown. For this reason, all men and women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, throughout the duration of study participation, and for at least 6 months after receiving the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Non-English speaking participants are allowed to enroll even if they skip answering quality-of-life (QOL) questionnaires. Special efforts will be made through community advisory boards at participating sites to reach Spanish speaking participants\n* Willing to undergo testing for human immunodeficiency virus (HIV) testing if not tested within the past 6 months\n* Willing to undergo hepatitis B and C screening if not tested within the past 6 months\n* Willing and able to adhere to the prohibitions and restrictions specified in the approved protocol\n* Willingness to moderate alcohol intake (consuming no more than 1 or 2 alcoholic drinks per day for women and men, respectively)\n* Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)\n\nExclusion Criteria:\n\n* History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment\n* Prior use of OCA\n* Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy\n* Cutaneous diseases manifesting with severe pruritus\n* Individuals with active, known or suspected chronic liver disease including cirrhosis, nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis, primary sclerosing cholangitis, biliary atresia\n* Individuals with acute cholecystitis (defined by a syndrome of right upper quadrant pain, fever, and leukocytosis associated with gallbladder inflammation)\n* Individuals with a history of pancreatitis or pancreatic abnormalities\n* Individuals with hepatic steatosis and velocity \\> 1.7 m\u002Fsec as determined by liver ultrasound elastography. Results of a right upper quadrant ultrasound with elastography performed within 6 months of starting study treatment may be used to assess this criteria\n* Individuals with hyperlipidemia that is not well controlled with the use of pharmacotherapy and\u002For dietary modifications\n* History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof\n* Individuals with known hypersensitivity, allergies, or intolerance to the study drug or compounds of similar chemical or biologic composition\n* Any serious and\u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Individuals with active and untreated hepatitis C virus (HCV) and\u002For or hepatitis B virus (HBV) infection\n* Individuals with HIV infection are eligible for participation if:\n\n  * CD4+ count \\>= 300\u002FuL\n  * Viral load is undetectable\n  * Receiving highly active antiretroviral therapy (HAART) without known or suspected drug interactions with OCA\n  * Consultation with the participant's infectious disease specialist may be obtained\n* Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 5 half-lives days prior to starting OCA or placebo on this study. Consultation with the participant's primary care provider may be obtained but is not required.\n\n  * The use of the following drugs or drug classes is prohibited during OCA\u002Fplacebo treatment\n\n    * Investigational agents;\n    * Bile acid sequestrants (bile acid binding resins): cholestyramine, colestipol, or colesevelam;\n    * Bile salt efflux pump (BSEP) inhibitors;\n    * Clozapine;\n    * Theophylline derivatives;\n    * Tizanidine;\n    * Warfarin;\n    * Hepatotoxic drugs such as amiodarone, sodium valproate, certain herbal\u002Fdietary supplements, and long-term doxycycline or tetracycline\n* Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contraceptive method. Pregnant women are excluded from this study because OCA is an agent with unknown effects on the developing human fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OCA, breastfeeding should be discontinued if the mother is treated with OCA\n* Participants may not be receiving any other investigational agents",{"count":491,"type":20},30,[23],"This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.",[26,29],{"date":479,"type":34},{"date":497,"type":34},"2024-01-03",{"date":499,"type":20},"2027-09-01",{"name":40,"class":41},8,{"id":503,"slug":4,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":21,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":42},"100626181","NCT07432295","Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)","A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Treatment-naïve for advanced\u002Fmetastatic disease (prior adjuvant\u002Fneoadjuvant therapy allowed if ≥6 months since last dose).\n* CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).\n* PD-L1 positive (CPS ≥1).\n* At least 1 measurable lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Adequate organ function, including:\n\n  * Hematologic: WBC ≥2,000\u002FμL; ANC ≥1,500\u002FμL; platelets ≥100,000\u002FμL; hemoglobin ≥9 g\u002FdL\n  * Hepatic: AST\u002FALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)\n  * Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL\u002Fmin\u002F1.73 m²\n* Life expectancy ≥90 days.\n* Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.\n* Willing and able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* HER2-positive tumors.\n* Second malignancy within 3 years, except certain skin or cervical cancers.\n* Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.\n* Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.\n* Active pneumonitis or history requiring steroids\u002Fimmunosuppressive therapy within 3 years.\n* Participation in another therapeutic clinical trial.\n* Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.\n* Radiotherapy within protocol-specified timeframes without adequate recovery.\n* Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).\n* Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA\u002Fstroke, or major cardiac procedures within 6 months).\n* Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).\n* Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.\n* Active infection requiring parenteral therapy.\n* Known hypersensitivity to study drug components (e.g., DPD deficiency).\n* Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.",{"count":509,"type":20},180,[23],"The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and\u002For esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:\n\n* Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?\n* What toxicities do participants experience when taking givastomig?\n\nParticipants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.\n\nUp to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.\n\nParticipants will:\n\n* Visit the study treatment center for infusions and\u002For check-ups and tests every 1-3 weeks\n* Report any changes in their symptoms to their study doctors\n* Have scans to check for any changes in their cancer every 8-12 weeks",[513,514,515,177,516,29],"Solid Tumor","Advanced Cancer","Metastatic Cancer","Gastroesophageal Junction Carcinoma","2026-05-11",{"date":324,"type":34},{"date":520,"type":34},"2026-02-11",{"date":522,"type":20},"2030-08",{"name":524,"class":163},"I-Mab Biopharma US Limited",{"id":526,"slug":4,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":21,"phases":533,"briefSummary":534,"conditions":535,"keywords":545,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":567},"100392410","NCT04389632","A Study of Sigvotatug Vedotin in Advanced Solid Tumors","A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors","Inclusion Criteria:\n\n* Disease indication\n\n  * Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell cancer (HNSCC)\n    * Advanced HER2-negative breast cancer\n    * Esophageal squamous cell carcinoma (ESCC)\n    * Esophageal\u002FGastro-esophageal junction adenocarcinoma (EAC\u002FGEJ)\n    * Cutaneous squamous cell cancer (cSCC)\n    * Exocrine pancreatic adenocarcinoma\n    * Bladder cancer\n    * Cervical cancer\n    * Gastric cancer\n    * High grade serous ovarian cancer (HGSOC)\n  * Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.\n  * Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1\u002FPD-(L)1 inhibitor, if applicable and available.\n  * Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \\[neo\\]adjuvant therapy is allowed).\n  * Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.\n* Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:\n\n  * Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.\n  * Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Measurable disease per the RECIST v1.1 at baseline\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.\n* Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:\n\n  * are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,\n  * have no new or enlarging brain metastases, and\n  * are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.\n  * In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.\n* Carcinomatous meningitis\n* Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6\n* Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts\n* Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.\n\n  * Routine antimicrobial prophylaxis is permitted\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses\n* Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).\n* History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening\n* Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \\\u003C50% predicted\n* Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":532,"type":20},1006,[149],"This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.\n\nThe study will have four parts.\n\n* Part A of the study will find out how much sigvotatug vedotin should be given to participants.\n* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.\n* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.\n* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.\n* In Parts C and D, participants will receive sigvotatug vedotin with either:\n\n  * Pembrolizumab or,\n  * Pembrolizumab and carboplatin, or\n  * Pembrolizumab and cisplatin.",[536,537,538,341,29,154,539,540,541,542,543,544],"Carcinoma, Non-Small Cell Lung","Squamous Cell Carcinoma of Head and Neck","HER2 Negative Breast Neoplasms","Ovarian Neoplasms","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms","Stomach Neoplasms",[224,227,546,547,548,549,550,551,552,553,554,555,556,557,177,558],"cSCC","ESCC","EAC","GEJ","HGSOC","Advanced HER2-Negative Breast Cancer","High Grade Serous Ovarian Cancer","Non-Small Cell Lung Cancer","Head and Neck Squamous Cell Cancer","Esophageal Cancer","Bladder Cancer","Cervical Cancer","Seattle Genetics","2026-05-08",{"date":517,"type":34},{"date":562,"type":34},"2020-06-08",{"date":564,"type":20},"2029-03-22",{"name":566,"class":163},"Seagen, a wholly owned subsidiary of Pfizer",159,{"id":569,"slug":4,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":21,"phases":576,"briefSummary":577,"conditions":578,"keywords":582,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":593},"100594562","NCT07021066","Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Signed the informed consent form voluntarily and agreed to follow the program requirements\n2. Age: ≥18 years\n3. Has a life expectancy of ≥3 months\n4. Has documented locally advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant\u002Fneoadjuvant), have no other standard of care options, and have no available curative options, including:\n\n   1. Gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma (AC): Subjects with CLDN18.2, human epidermal growth factor receptor 2 (HER2), PD-L1 and\u002For microsatellite instability high (MSI-H)\u002F mismatch repair deficiency (dMMR) positive tumors must have received targeted treatment in their prior lines of therapy.\n   2. Pancreatic ductal AC (PDAC): Subjects may enter screening prior to completing the first line of standard therapy.\n   3. Esophageal AC (EAC): Subjects with HER2, PD-L1 and\u002For MSI-H\u002FdMMR positive tumors must have received targeted treatment in their prior lines of therapy.\n   4. Biliary tract cancers (BTCs): Subjects with HER2 overexpression, NTRK fusions, KRAS mutations, IDH1 mutations, FGFR2 fusions, BRAF mutations and\u002For MSI-H\u002FdMMR positive tumors must have received targeted treatment in their prior lines of therapy.\n   5. Other solid tumors not specified above may be included IF they have documented CLDN18.2 expression by IHC (1+). As applicable per standard of care, subjects with HER2 and\u002For PD-L1 positive tumors must have received targeted treatment in their prior lines of therapy, and subjects with MSI-H or dMMR positive tumors must have received immune checkpoint inhibitor.\n5. Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded \\[FFPE\\] tissue block or slides) from primary or metastatic sites (see details in Section 7.1.1) for tissue-based evaluation of CLDN18.2 expression. A fresh biopsy is required if no archival\u002FFFPE block or slides are available. Re-biopsy is recommended if the subject previously received a CLDN18.2-directed treatment.\n6. Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1\n7. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n8. Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by the National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n9. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n10. Has adequate organ function before enrollment, defined as:\n\n    1. Marrow function: Absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (Hb) ≥9.0 g\u002FdL (blood transfusion, platelet transfusion, erythropoietin, hematopoiesis agents, and granulocyte-colony stimulating factor \\[G-CSF\\] use are not allowed 1 week prior to screening)\n    2. Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (≤3×ULN for subjects with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN NOTE: For patients with Gilbert's syndrome, conjugated bilirubin ≤1.5×ULN and TBIL \\\u003C3.0×ULN in the absence of liver metastases.\n    3. Renal function: Creatinine (Cr) clearance ≥60 mL\u002Fmin (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n11. Coagulation parameters: 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\n12. Urine protein ≤2+ or ≤1000 mg\u002F24 hours\n13. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception (defined in Appendix E) during the course of the study and after the last dose of study treatment (7 months for women and 4 months for men). An additional contraceptive method, such as a barrier method (eg, condom), is recommended.\n14. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes. In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (FSH) level \\>40 mIU\u002FmL to confirm menopause.\n\nNote: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\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, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment\n3. Subjects with prolonged QT interval corrected (\\[QTcF\\] \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc. Subjects with well-controlled type 1 diabetes, hypothyroidism, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis) are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening\n5. Subjects with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening\n6. Subjects with poorly controlled hypertension by two 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 who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n9. Subjects with stroke or transient ischemic attack (TIA) within 6 months before enrollment\n10. 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\n11. Subjects 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.\n12. Subjects with pre-existing Grade ≥2 peripheral neuropathy\n13. Subjects who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M05D1\n14. 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\n15. Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2\n16. Subjects with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Subjects are allowed to participate if all the following criteria are met:\n\n    1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n    2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n    3. 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.\n17. Subjects with known active hepatitis B virus (HBV) infection (positive HBsAg test). Subjects with a chronic inactive HBV infection are eligible if all the following criteria are met:\n\n    1. Have an HBV DNA viral load \\\u003C 500 IU\u002FmL;\n    2. Have normal AST and ALT, OR if liver metastasis is present, have AST and ALT \\\u003C3×ULN which are not attributed to HBV infection;\n    3. Are on antiviral treatment, as clinically indicated.\n18. 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 quantitative polymerase chain reaction (PCR) is negative for HCV RNA\n19. Subjects with known active tuberculosis\n20. 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\n21. Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study\n22. Other conditions that the investigator believes are not suitable for participating in this clinical trial.",{"count":575,"type":20},160,[149],"The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.",[203,579,29,580,581],"Advanced Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer","Other Solid Tumors",[583],"CLDN 18.2","2026-04-29",{"date":586,"type":34},"2026-04-30",{"date":588,"type":34},"2025-07-30",{"date":590,"type":20},"2027-05-31",{"name":592,"class":163},"SystImmune Inc.",17,{"id":595,"slug":4,"hasResults":11,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":21,"phases":602,"briefSummary":603,"conditions":604,"keywords":605,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100542272","NCT06340711","Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma","Phase II Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in PD-L1-Negative or Immunotherapy-refractory Esophagogastric Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma amenable to intra-tumoral injection (i.e. at least 1 cm in size)\n* Tumor must be examined forPD-L1 assessment as defined by a Combined Positive Score (CPS), and approved commercial diagnostic assay\n* If the PD-L1 CPS score is \\> 1, patients must have received at least one line of systemic therapy for advanced disease that includes a PD-1 or PD-L1 inhibitor.\n\n  1. Patients must have clinical or radiographic disease progression on 1L therapy, or within three months of the last dose of immunotherapy\n  2. Patients must be eligible for immunotherapy (i.e. have not had a Grade 3 or 4 immunotherapy related gastrointestinal or pulmonary toxicity, or other immune-related adverse event that excludes them from receiving future immunotherapy per PI discretion)\n* If the PD-L1 CPS score is \\\u003C 1, patients must not have received prior anti-PD-1 or PD-L1 therapy and must have received at least one line of systemic therapy for advanced disease.\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 3 weeks of study Day 1.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than equivalent of 20 mg\u002Fday) or any other form of immunosuppressive therapy within 7 days prior to study Day 1.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has had prior anti-cancer monoclonal antibody chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, who has not recovered from adverse events due to a previously administered agent.\n* Has a known additional malignancy within 3 years before the first OBP-301 administration that is progressing or requires active treatment, with the exception of prostate cancer controlled with androgen deprivation therapy.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Is known to have acute or chronic active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy within 2 weeks of Day 1.\n* Is unable to comply with protocol procedures\n* Previous severe hypersensitivity (≥ Grade 3) to any monoclonal antibody\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Has certain uncontrolled illnesses\n* Is pregnant or breastfeeding or planning to become pregnant or start breast feeding during the study time period\n* Is expecting to get someone else pregnant during the study time period",{"count":601,"type":20},27,[23],"The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer.\n\nParticipants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections.",[29,203,154],[606,607,608],"Pembrolizumab","OBP-301","Immunotherapy","2026-04-21",{"date":611,"type":34},"2026-04-23",{"date":613,"type":34},"2024-04-25",{"date":615,"type":20},"2030-04",{"name":617,"class":88},"Weill Medical College of Cornell University",2,{"id":620,"slug":4,"hasResults":11,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":21,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":89},"100610118","NCT07223424","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","PSI-Immune","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document.\n* Able to read and write in English.\n* Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.\n* Prior and concurrent therapy criteria\n\n  o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).\n* Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.\n\n  * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric\u002FGEJ).\n  * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, gastric\u002FGEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).\n* Cohort-specific criteria.\n\n  * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.\n  * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.\n  * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced\u002Fmetastatic melanoma, ccRCC, MSI-H\u002FdMMR mCRC.\n  * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).\n  * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.\n\nExclusion Criteria:\n\n* Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":627,"type":20},880,[23],"The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.",[631,632,223,633,225,634,555,635,636,557,637,29],"Renal Cell Carcinoma","Non Small Cell Lung Cancer","Colo-rectal Cancer (dMMR\u002FMSI-H CRC)","Ulcerative Colitis","Squamous Cell Carcinoma","Gastric\u002FGEJ","Gastro-Esophageal Adenocarcinoma","2026-04-13",{"date":640,"type":34},"2026-04-16",{"date":642,"type":34},"2025-11-04",{"date":644,"type":20},"2030-11-30",{"name":646,"class":88},"Diwakar Davar",{"id":648,"slug":4,"hasResults":11,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":652,"eligibilityCriteria":653,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":21,"phases":655,"briefSummary":656,"conditions":657,"keywords":659,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":89},"100496563","NCT05745857","Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas","A Phase 2 Intervention Study: Detection of Early Esophageal Neoplastic Lesions by Quantified Fluorescence Molecular Endoscopy Using Oral and Topical Administration of Bevacizumab-800CW and Cetuximab-800CW","SLURP","Inclusion Criteria:\n\n* BE patients without dysplasia and with suspected\u002Fdiagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and\u002For therapeutic endoscopy\n* Written informed consent is obtained\n\nExclusion Criteria:\n\n* Patients under the age of eighteen.\n* Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis (TNM)-classification other than T1.\n* Previous radiation therapy for esophageal cancer\n* Known immunoglobulin allergy\n* Previous chemotherapy, immunotherapy or related surgery\n* Prior bevacizumab or cetuximab treatment\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent\n* Pregnancy or breast feeding.",{"count":7,"type":20},[23],"Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.",[389,658,29],"Barrett Oesophagitis With Dysplasia",[660,661,662,262],"Fluorescence molecular endoscopy","Spectroscopy","Barrett's esophagus","2026-04-07",{"date":638,"type":34},{"date":666,"type":34},"2023-09-15",{"date":668,"type":20},"2026-12",{"name":670,"class":88},"University Medical Center Groningen",""]