[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-junction-adenocarcinoma":35},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,102,139,167,189,213,236,252,281,308,331,351,378,428,449,468,491,513,540,587,612,641,674,724,745],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928",false,"NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"ALL","40 Years","75 Years",{"count":22,"type":23},2000,"ESTIMATED","OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma","RECRUITING","2026-07-01",{"date":92,"type":93},"2026-07-02","ACTUAL",{"date":95,"type":93},"2022-08-18",{"date":97,"type":23},"2027-02-28",{"name":99,"class":100},"Alliance for Clinical Trials in Oncology","OTHER",745,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100626103","phase-3-sonesitatug-vedotin-in-combination-with-capecitabine-with-or-without-rilvegostomig-in-participants-with-advanced-or-metastatic-gastric-gastroesophageal-junction-or-esophageal-adenocarcinoma-expressing-claudin182-100626103","NCT07431281","Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2","A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced\u002FMetastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)","Inclusion Criteria:\n\n* Capable of giving signed informed consent\n* Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.\n* Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma\n* Positive CLDN18.2 expression, as determined prospectively by central IHC testing\n* Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:\n\n  1. Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.\n  2. Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible\n* ECOG performance status of 0 or 1 with no deterioration to \\> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.\n* Minimum life expectancy of ≥ 12 weeks.\n* At least one lesion (measurable and\u002For non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.\n* Adequate organ and bone marrow function as specified in the protocol\n* Body weight ≥ 35 kg.\n* Sex and contraceptive requirements\n\nExclusion Criteria:\n\n* Known HER2-positive status\n* Significant or unstable gastric bleeding and\u002For untreated gastric ulcers.\n* Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.\n* CNS pathology\n* Clinically significant pleural effusions or ascites and\u002For pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter\u002Fdrain.\n* Require parenteral nutrition support due to gastric or gastrointestinal obstruction.\n* Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.\n* Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.\n* Cardiac abnormalities as outlined in the protocol\n* Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.\n* Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and\u002For chronic or active hepatitis B with HBV DNA ≥ 100 IU\u002FmL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled\n* Known partial or total DPD enzyme deficiency","18 Years",{"count":111,"type":23},2130,"INTERVENTIONAL",[114],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.",[117,35,118],"Gastric Cancer","Esophageal Cancer",[120,121,122,123,124,125,126,127,128],"Advanced Gastroesophageal Junction (GEJ) Adenocarcinoma,","Advanced Gastric Adenocarcinoma,","Advanced Esophageal Adenocarcinoma,","Metastatic Gastric Adenocarcinoma,","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma,","Metastatic Esophageal Adenocarcinoma,","Claudin 18.2,","PD-L1,","Human epidermal growth factor receptor 2 (HER2) Negative","2026-06-30",{"date":90,"type":93},{"date":132,"type":93},"2026-02-03",{"date":134,"type":23},"2031-10-27",{"name":136,"class":137},"AstraZeneca","INDUSTRY",286,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":112,"phases":148,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100541015","phase-1-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-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":23},768,[149,150],"PHASE1","PHASE2","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.",[153,154,35,155,156],"Metastatic Breast Cancer","Metastatic Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Colorectal Cancer","2026-06-23",{"date":159,"type":93},"2026-06-24",{"date":161,"type":93},"2024-06-03",{"date":163,"type":23},"2029-01-08",{"name":165,"class":137},"Boehringer Ingelheim",108,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":112,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100596280","phase-3-a-study-to-investigate-tislelizumab-administered-as-subcutaneous-injection-versus-intravenous-infusion-plus-chemotherapy-in-patients-with-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100596280","NCT07043400","A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed, locally advanced unresectable or metastatic gastric\u002F gastroesophageal junction (GEJ) adenocarcinoma.\n* No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n* At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.\n* Must be able to provide tumor tissues for biomarker assessment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.\n* Adequate organ function.\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.\n\nExclusion Criteria:\n\n* Squamous cell or undifferentiated or other histological type gastric cancer (GC)\n* Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.\n* Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).\n* Active autoimmune diseases or history of autoimmune diseases that may relapse.\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to randomization\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":175,"type":23},351,[114],"This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.",[154,35],"2026-06-18",{"date":181,"type":93},"2026-06-22",{"date":183,"type":93},"2025-08-27",{"date":185,"type":23},"2028-04-22",{"name":187,"class":137},"BeOne Medicines",94,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":112,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":212},"100519056","phase-2-a-study-of-trk-950-when-used-in-combination-with-ramucirumab-and-paclitaxel-in-patients-with-gastric-cancer-100519056","NCT06038578","A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.\n* The patient is eligible to receive Ramucirumab + Paclitaxel.\n* Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and\u002For cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history:\n\n  1. First treatment for metastatic disease or locally advanced disease without experiencing adjuvant \u002F neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment\n  2. Adjuvant \u002F neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment\n  3. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment\n  4. Adjuvant \u002F neo-adjuvant treatment which progressed during treatment or within 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during treatment or within 4 months after the last dose of treatment\n* Presence of primary or metastatic disease, measurable per RECIST v1.1 on CT scan.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Age ≥ 18 years in the US and Japan, and ≥ 19 years of age in Korea.\n* Signed, written IRB-approved informed consent.\n* Adequate organ function from specimens collected within 14 days prior to Day 1.\n* For men and women of child-producing potential, the use of effective contraceptive methods during the study and for 6 months after the last dose of TRK-950.\n* All patients must sign a pre-screening consent to assess tumor tissue to determine eligibility. Tumor tissue must be evaluable for CAPRIN-1 staining at a CLIA certified laboratory and meet or exceed the cutoff value (30% at ≥ 2+ staining) as defined in the expression level requirements.\n\nExclusion Criteria:\n\n* Prior history of treatment with ramucirumab or paclitaxel.\n* HER2 positive gastric or GEJ adenocarcinoma.\n* Major surgery within 28 days prior to randomization.\n* Baseline corrected QT (QTc) interval of \\> 470 msec for females and \\> 450 msec for males calculated using Fridericia's formula.\n* New York Heart Association (NYHA) Class II - IV symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia.\n* The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 3 months prior to randomization.\n* The patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Clinically symptomatic venous thromboembolism or current treatment with anti-coagulants. (Patients receiving prophylactic and low-dose anticoagulation therapy are eligible provided that the coagulation parameter defined in the Inclusion Criterion 9 is met.)\n* Uncontrolled arterial hypertension ≥ 150 mmHg (systolic) or ≥ 90 mmHg (diastolic) despite standard medical management.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy within 2 weeks, or treatment with chemotherapy, immunotherapy, targeted therapy, or investigational therapy within 4 weeks prior to randomization (within 2 weeks for Oral FU (S1 and capecitabine)).\n* The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to randomization.\n* Clinically significant ascites, paracentesis in the last 3 months, or undergoes regular paracentesis procedures.\n* History of gastrointestinal perforation and\u002For fistulae within 6 months prior to randomization.\n* The patient has a serious or non-healing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.\n* The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (e.g., hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n* Known active infection with HIV, hepatitis B or hepatitis C. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.\n* The patient is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients who have recently discontinued dosing of study drug are eligible to participate as long as the final dose of study drug was ≥ 28 days from randomization for participation in this study. Patients participating in surveys or observational studies are eligible to participate in this study.",{"count":197,"type":23},146,[150],"This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.",[201,117,35],"Gastric Adenocarcinoma",[203,35,204,205],"Gastric Cancer, Adenocarcinoma","TRK-950","CAPRIN-1",{"date":157,"type":93},{"date":208,"type":93},"2023-10-04",{"date":129,"type":23},{"name":211,"class":137},"Toray Industries, Inc",27,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":220,"targetDuration":222,"studyType":24,"phases":4,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100644416","emotional-distress-and-pathologic-response-in-locally-advanced-gastricgej-adenocarcinoma-100644416","NCT07662070","Emotional Distress and Pathologic Response in Locally Advanced Gastric\u002FGEJ Adenocarcinoma","A Prospective Observational Study of the Association Between Pretreatment Emotional Distress and Pathologic Response to Perioperative Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Willing to participate in this study.\n2. Age \\>18 years; both sexes are eligible.\n3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n4. Resectable locally advanced disease as assessed by imaging and\u002For multidisciplinary team evaluation, generally corresponding to AJCC 8th edition stage II-III disease, including cT3-4a with any N category or any T with node-positive disease, without distant metastasis.\n5. Planned to receive neoadjuvant therapy followed by curative-intent surgery.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. No prior systemic antitumor treatment for the current tumor at baseline.\n8. Able to understand and complete questionnaire assessments.\n9. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or loss of curative treatment opportunity as determined by clinical evaluation.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic antitumor treatment for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any condition that precludes completion of questionnaire assessments.\n4. Current treatment with antidepressants, anxiolytics, or other psychotropic medications with any of the following within 4 weeks before baseline assessment: initiation, discontinuation, change in medication type, dose adjustment of 50% or more, or addition of a second or more psychotropic medication.\n5. Any other condition judged by the investigator to make the participant unsuitable for enrollment.",{"count":221,"type":23},120,"3 Years","This is a single-center, prospective observational cohort study designed to evaluate the association between pretreatment emotional distress and pathologic response to perioperative immunotherapy in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 120 patients planned for neoadjuvant immunotherapy followed by curative surgery will be enrolled. Emotional distress will be assessed using the PHQ-9 and GAD-7 before treatment initiation and at prespecified time points during treatment. Participants will be classified into an emotional distress group or a non-emotional distress group according to predefined criteria. The primary endpoint is major pathological response (MPR). Secondary endpoints include pathological complete response (pCR), R0 resection rate, event-free survival (EFS), recurrence-free survival (RFS), and overall survival (OS). Exploratory analyses will assess dynamic changes in emotional distress and their associations with peripheral stress markers, peripheral immune markers, and tumor immune microenvironment features.",[201,35,225,226],"Emotional Distress","Pathologic Response","NOT_YET_RECRUITING","2026-06-17",{"date":157,"type":93},{"date":231,"type":23},"2026-06-26",{"date":233,"type":23},"2028-12-31",{"name":235,"class":100},"West China Second University Hospital",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":243,"targetDuration":222,"studyType":24,"phases":4,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":251,"locationsCount":4},"100644388","objective-sleep-characteristics-and-neoadjuvant-immunotherapy-response-in-gastricgej-cancer-100644388","NCT07662005","Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric\u002FGEJ Cancer","Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Prospective Observational Study","Inclusion Criteria:\n\n1. Age greater than 18 years, regardless of sex.\n2. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n3. Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.\n4. Scheduled to receive neoadjuvant therapy followed by radical surgery.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.\n6. No prior systemic anticancer therapy for the current tumor at study baseline.\n7. Willing to participate in the study and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.\n2. Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.\n3. Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.\n4. Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:\n\n   1. Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;\n   2. Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;\n   3. Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;\n   4. Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.\n5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.",{"count":221,"type":23},"This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.",[201,35,246,247],"Sleep","Pathological Response",{"date":157,"type":93},{"date":231,"type":23},{"date":233,"type":23},{"name":235,"class":100},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":112,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":280},"100593077","phase-2-testing-the-addition-of-paclitaxel-administered-into-the-abdominal-cavity-combined-with-chemotherapy-for-patients-with-gastric-cancer-spread-to-the-abdominal-cavity-100593077","NCT07001748","Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity","Protocol EA2234: A Randomized Phase II\u002FIII Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II","STOPGAP II","STEP 0 REGISTRATION:\n\n* Patient must be at least 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H\u002FdMMR) mismatch repair deficient disease are not eligible\n* Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment\n* Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy\n* Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy\n* Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration\n* Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy\n* Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy\n* Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement\n* Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin\n* Leukocytes ≥ 2,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (≤ 30 days prior to Step 0 registration)\n* Platelets ≥ 75,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \\\u003C 2.0 mg\u002FdL (≤ 30 days prior to Step 0 registration)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration)\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)\n* Hemoglobin ≥ 8 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Serum albumin ≥ 2.5 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n\nSTEP 1 RANDOMIZATION:\n\n* Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained\n* The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available\n* Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port",{"count":261,"type":23},148,[150,114],"This study is being done to answer the following questions:\n\nCan we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer.\n\nIf you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below.\n\nIf you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen).\n\nIf you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment.\n\nIt is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in.\n\nOnce you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon.\n\nThere is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called \"intra-abdominal adhesions\". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help.\n\nAfter you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest\u002FAbdomen\u002FPelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.",[201,35,265],"Peritoneal Carcinomatosis",[267,268,258,269,270],"EA2234","Intraperitoneal Paclitaxel","STOPGAP I","Gastric Carcinomatosis","2026-06-16",{"date":228,"type":93},{"date":274,"type":93},"2025-08-19",{"date":276,"type":23},"2030-05-30",{"name":278,"class":279},"ECOG-ACRIN Cancer Research Group","NETWORK",55,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":112,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100641848","phase-2-taic-folfox-for-locally-advanced-ggeja-100641848","NCT07655024","TAIC FOLFOX for Locally Advanced G\u002FGEJA","FOLFOX-Based Transarterial Infusion Chemotherapy for Locally Advanced Gastric Cancer and Gastroesophageal Junction Adenocarcinoma: Protocol of an Open-Label, Multicentre, Single-arm, Phase Ⅱ Trial","TFLAG","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Pathologically diagnosed with G\u002FGEJA\n* Confirmed by the surgeon as initially unresectable advanced G\u002FGEJC\n* Contraindicated to surgery due to frailty or comorbidities\n* Expected survival period ≥ 3 months\n\nExclusion Criteria:\n\n* Primary malignant tumors\n* Gastrointestinal obstruction caused by lesions in the distal stomach, duodenum, pancreas or other organs\n* Acute infection, severe liver or kidney dysfunction or coagulation disorder\n* Allergic to the drugs or with mental disorders",{"count":290,"type":23},31,[150],"Gastric cancer is the fifth most common malignancy worldwide in terms of both incidence and mortality. The majority of cases are diagnosed at advanced stage-often presenting with severe complications such as malignant stricture, obstruction, bleeding, and cancer-related malnutrition-which impinge on quality of life and survival outcomes. For patients with unresectable or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (G\u002FGEJA), first-line systemic therapy remains predominantly platinum- and fluoropyrimidine-based combination chemotherapy, and targeted agents or immunotherapy can be added based on the expression of biomarkers. Under this standard approach, the median overall survival (mOS) for localized unresectable G\u002FGEJA is approximately 14-20 months. For metastatic G\u002FGEJA, the prognosis remains poor with an mOS of less than 1 year, despite the proven efficacy of chemotherapeutic agents. Moreover, up to 25% of cancer survivors report a significant decline in quality of life due to gastrointestinal symptoms during, soon after, or many years after treatment.\n\nInterventional oncology approaches-including trans-arterial infusion chemotherapy (TAIC), embolization (TAE), and chemoembolization (TACE)-represent promising locoregional therapeutic strategies. TAIC allows for the direct delivery of cytotoxic agents into the tumor-feeding arteries, thereby maximizing intra-tumoral drug concentration. As one of the most well-recognized applications, hepatic arterial infusion chemotherapy (HAIC) has been demonstrated in liver cancer by elevating local drug exposure, markedly enhancing antitumor efficacy while minimizing systemic adverse effects. Moreover, chemotherapeutic agents may exert secondary systemic activity against clinically or subclinically disseminated metastases upon systemic circulation, contributing to a sustained \"secondary chemotherapy\" effect. Owing to its favorable safety profile and preserved antitumor activity, TAIC is particularly suited for frail or elderly patients who are ineligible for surgery or conventional systemic chemotherapy.\n\nGiven the persistent limitations of current therapeutic paradigms, the feasibility and safety of trans-arterial therapy in the treatment of anti-tumor, hemostasis and obstruction relief for locally advanced G\u002FGEJC remains urgent. The present study aimed to assess the efficacy and safety of TAIC for locally advanced G\u002FGEJA.",[294,35],"Gastric Cancer (Diagnosis)",[296,297,298],"Unresectable Gastric cancer","Esophagogastric junction adenocarcinoma","Transarterial infusion chemotherapy","2026-06-15",{"date":228,"type":93},{"date":302,"type":93},"2025-11-01",{"date":304,"type":23},"2028-12-01",{"name":306,"class":100},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences",1,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":20,"enrollmentInfo":315,"targetDuration":4,"studyType":112,"phases":317,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":327,"leadSponsor":329,"locationsCount":4},"100641601","phase-2-hipec-priming-followed-by-serplulimab-plus-soxxelox-in-locally-advanced-gastric-cancer-100641601","NCT07621484","HIPEC Priming Followed by Serplulimab Plus SOX\u002FXELOX in Locally Advanced Gastric Cancer","A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX\u002FXELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive); gender unrestricted.\n* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma via endoscopic biopsy.\n* Clinical stage cT3-4a (imaging evidence of tumor invasion into or penetration through the serosa), any N (lymph node positive), M0 (no distant organ metastasis), based on the 8th Edition of the AJCC Staging Manual.\n* HER2-negative disease, defined as HER2 IHC 0 or 1+, or IHC 2+ with negative ISH.\n* Diagnostic laparoscopy confirms the absence of macroscopic peritoneal metastasis (P0) and negative peritoneal lavage cytology (CY0).\n* Adequate cardiac function, rendering the patient eligible for curative-intent resection. If clinically indicated, patients with underlying ischemic heart disease, valvular heart disease, or other severe cardiac conditions must undergo a preoperative cardiac evaluation by a cardiologist.\n* ECOG Performance Status (PS) score of 0 or 1 within 7 days prior to enrollment.\n* Anticipated survival time of ≥ 6 months.\n* Hepatitis B surface antigen (HBsAg) negative (-) and Hepatitis B core antibody (HBcAb) negative (-). If HBsAg is positive (+) or HBcAb is positive (+), the Hepatitis B virus DNA (HBV-DNA) level must be \\\u003C 1000 copies\u002FmL, \\\u003C 200 IU\u002FmL, or below the upper limit of normal (ULN) at the study center to be eligible for enrollment.\n* HCV antibody negative (-).\n* Major organ function is normal, defined as meeting the following criteria (having not received transfusions of blood products, albumin, recombinant human thrombopoietin, or colony-stimulating factors \\[CSF\\] within 14 days prior to randomization):\n\nHematologic System Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL Platelets (PLT) ≥ 100×10⁹\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Liver Function Total Bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Aspartate Aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Alkaline Phosphatase (ALP) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver and\u002For bone metastases Albumin ≥ 25 g\u002FL Renal Function Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) Coagulation Function Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN Prothrombin Time (PT) ≤ 1.5×ULN International Normalized Ratio (INR) ≤ 1.5×ULN -Female patients must meet the following criteria:\n\nBe in a postmenopausal state (defined as having had no menstruation for at least 1 year, with no other confirmed cause for amenorrhea other than menopause), or have undergone surgical sterilization (removal of ovaries and\u002For uterus); alternatively, patients with reproductive potential must simultaneously meet the following requirements:\n\n* A serum pregnancy test result must be negative within 7 days prior to randomization;\n* Agree to use a contraceptive method with an annual failure rate of \\\u003C 1% or practice abstinence (avoidance of heterosexual intercourse) (from the time of signing the informed consent form until at least 120 days after the last dose of the investigational drug, and at least 6 \\[months\\] after the last dose of the chemotherapy drug ...months (contraceptive methods with an annual failure rate of \\\u003C 1% include bilateral tubal ligation, vasectomy, correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices \\[IUDs\\], and copper-containing IUDs);\n* Must not be breastfeeding. -Male patients must meet the following criteria: Agree to practice abstinence (avoid heterosexual intercourse) or use contraception, as specified below: If the partner is a female of childbearing potential or is pregnant, the male patient must practice abstinence or correctly use condoms for contraception-to prevent drug exposure to the embryo-during the chemotherapy treatment period and for at least 6 months after the last dose of chemotherapy medication, and for at least 120 days after the last dose of the investigational drug. The reliability of sexual abstinence should be evaluated with reference to the duration of the clinical study, patient preference, and lifestyle. Periodic abstinence (e.g., calendar-based, ovulation-based, basal body temperature, or post-ovulation methods) and withdrawal (coitus interruptus) are not considered acceptable methods of contraception.\n\nExclusion Criteria:\n\n* History of other active malignancies within the past 5 years, or the presence of other active malignancies at the time of enrollment. Patients with cured localized tumors-such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, or carcinoma in situ of the breast-are eligible for enrollment.\n* Presence of documented distant metastases (e.g., liver, lung, or bone metastases) or laparoscopically confirmed peritoneal seeding (P1).\n* Patients scheduled to undergo, or with a history of having undergone, organ or bone marrow transplantation.\n* Occurrence of myocardial infarction or poorly controlled arrhythmias (including a QTc interval ≥ 450 ms for males or ≥ 470 ms for females; QTc interval calculated using the Fridericia formula) within 6 months prior to enrollment.\n* Presence of NYHA Class III or IV heart failure, or a cardiac ultrasound result showing a Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%.\n* Human Immunodeficiency Virus (HIV) infection.\n* Presence of active pulmonary tuberculosis.\n* History of, or current presence of, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe impairment of pulmonary function that could interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Presence of a known active or suspected autoimmune disease. Exceptions are made for patients whose disease is in a stable state at the time of enrollment (defined as requiring no systemic immunosuppressive therapy).\n* Receipt of a live vaccine within 28 days prior to enrollment; inactivated viral vaccines for seasonal influenza are permitted.\n* Patients requiring systemic corticosteroid therapy (at a prednisone-equivalent dose \\> 10 mg\u002Fday) or other immunosuppressive medications within 14 days prior to enrollment or during the study period. However, the following exceptions are permitted: in the absence of active autoimmune disease, patients may use topical or inhaled corticosteroids, or receive adrenal replacement therapy at a prednisone-equivalent dose ≤ 10 mg\u002Fday.\n* Presence of any active infection requiring systemic anti-infective treatment within 14 days prior to enrollment; prophylactic antibiotic treatment (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease) is an exception.\n* Prior receipt of any anti-tumor therapy for the current gastric cancer, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.\n* Currently receiving treatment in another clinical study, or the planned start date of the treatment in this study is less than 14 days after the completion of treatment in a previous clinical study.\n* Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug.\n* Known history of substance abuse (including drug abuse); patients who have ceased alcohol consumption are eligible for enrollment.\n* Presence of any condition that may increase the risks associated with study participation or the investigational drug, or presence of other severe, acute, or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the clinical study.",{"count":316,"type":23},48,[150],"Patients with locally advanced gastric cancer (LAGC), particularly those with serosal invasion, remain at high risk of peritoneal recurrence despite standard perioperative treatment. Hyperthermic intraperitoneal chemotherapy (HIPEC) may eradicate free intraperitoneal tumor cells and microscopic peritoneal disease while potentially enhancing systemic anti-tumor immune activation.\n\nThis is a prospective, single-center, single-arm exploratory study evaluating a HIPEC priming strategy followed by serplulimab-based neoadjuvant therapy in patients with locally advanced gastric cancer (cT3-4aN+M0). Eligible patients will undergo diagnostic laparoscopy confirming no visible peritoneal metastasis (P0) and negative peritoneal cytology (CY0), followed by docetaxel-based HIPEC.\n\nAfter recovery from HIPEC, patients will initially receive one cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX\u002FXELOX chemotherapy prior to radical gastrectomy.\n\nThe primary endpoints are pathological complete response (pCR) rate and major pathological response (MPR) rate. Secondary endpoints include R0 resection rate, objective response rate (ORR), peritoneal recurrence-free survival (PRFS), overall survival (OS), and safety.",[320,201,35],"Locally Advanced Gastric Cancer",[320,322,323,324],"HIPEC","Hyperthermic Intraperitoneal Chemotherapy","Peritoneal Recurrence",{"date":228,"type":93},{"date":90,"type":23},{"date":328,"type":23},"2028-05-09",{"name":330,"class":100},"Shanghai Changzheng Hospital",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":112,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},"100574868","phase-3-a-phase--study-of-rilvegostomig-in-combination-with-fluoropyrimidine-and-trastuzumab-deruxtecan-as-the-first-line-treatment-for-her2-positive-gastric-cancer-100574868","NCT06764875","A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer","A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)","Inclusion Criteria:\n\n1. HER2 positive for gastric cancer on a tumor biopsy.\n2. PD-L1 combined positive score (CPS) ≥ 1.\n3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.\n4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.\n5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. Have measurable target disease assessed by the Investigator based on RECIST v1.1.\n7. Have adequate organ and bone marrow function.\n8. LVEF ≥ 50% within 28 days before randomization.\n9. Adequate treatment washout period before randomization.\n\nExclusion Criteria:\n\n1. Lack of physiological integrity of the upper gastrointestinal tract.\n2. Known dihydropyrimidine dehydrogenase enzyme deficiency.\n3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.\n4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.\n5. Persistent toxicities caused by previous anti-cancer therapy.\n6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n7. Uncontrolled infection including tuberculosis and active hepatitis A infection.\n8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.\n9. Recent receipt of live, attenuated vaccine.\n10. Chronic\u002Factive HBV or HCV infection unless controlled.\n11. Clinically significant cardiac or psychological conditions.\n12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n13. History of (non-infectious) ILD\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n14. Lung-specific intercurrent clinically significant illnesses.\n15. Any active non-infectious skin disease requiring systemic treatment.\n16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).\n17. History of any of the following: drug-induced severe cutaneous adverse reaction.\n18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.\n19. Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.\n20. Current or prior use of immunosuppressive medication within 14 days before study intervention.",{"count":339,"type":23},840,[114],"This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.",[343,35],"HER2-positive Gastric Cancer",{"date":271,"type":93},{"date":346,"type":93},"2025-03-01",{"date":348,"type":23},"2030-12-09",{"name":136,"class":137},293,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":20,"enrollmentInfo":358,"targetDuration":4,"studyType":112,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":374,"leadSponsor":376,"locationsCount":307},"100641256","phase-2-mannatide-combined-with-capox-and-tislelizumab-for-advanced-gastric-cancer-100641256","NCT07655661","Mannatide Combined With CAPOX and Tislelizumab for Advanced Gastric Cancer.","A Multicenter, Single-Arm, Phase II Study of Mannatide Combined With CAPOX and Tislelizumab as First-Line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma.","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma.\n2. Unresectable recurrent or metastatic disease confirmed by imaging and surgical evaluation.\n3. Age 18 to 75 years.\n4. Expected survival greater than 3 months.\n5. No prior systemic therapy for recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Previous neoadjuvant or adjuvant therapy is allowed if completed at least 6 months before enrollment without evidence of recurrence or progression.\n6. ECOG performance status 0-1.\n7. At least one measurable lesion according to RECIST version 1.1.\n8. Availability of tumor tissue for PD-L1 testing.\n9. Adequate hematologic, hepatic, renal, and coagulation function.\n10. Recovery of prior treatment-related toxicities to Grade 0-1 or baseline level.\n11. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n12. Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n1. HER2-positive gastric or gastroesophageal junction adenocarcinoma.\n2. Squamous cell carcinoma, undifferentiated carcinoma, or mixed histology.\n3. Active or uncontrolled central nervous system metastases.\n4. Uncontrolled pleural effusion, ascites, or clinically significant pericardial effusion.\n5. Weight loss greater than 20% within 2 months before enrollment.\n6. Major surgery within 28 days before enrollment.\n7. Prior anti-PD-1, anti-PD-L1, anti-CTLA-4, or other immune checkpoint inhibitor therapy.\n8. Active autoimmune disease requiring systemic treatment.\n9. Active hepatitis B, hepatitis C, or HIV infection.\n10. Interstitial lung disease or uncontrolled systemic disease.\n11. Significant cardiovascular disease within 6 months before enrollment.\n12. Known hypersensitivity to study drugs or their components.\n13. Participation in another interventional clinical trial within 4 weeks before enrollment.\n14. History of substance abuse or severe psychiatric disorder.\n15. History of rheumatic heart disease or known hypersensitivity to mannatide.\n16. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.",{"count":359,"type":23},52,[150],"This is a multicenter, open-label, single-arm phase II study evaluating the efficacy and safety of mannatide in combination with CAPOX chemotherapy and tislelizumab as first-line treatment for patients with recurrent or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n\nEligible patients will receive oxaliplatin, capecitabine, tislelizumab, and oral mannatide. Tumor response will be assessed according to RECIST version 1.1. Patients without disease progression after induction treatment may continue maintenance therapy with capecitabine, tislelizumab, and mannatide.\n\nThe primary objective is to evaluate objective response rate (ORR). Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), and safety. Exploratory analyses will investigate immune microenvironment changes and potential predictive biomarkers using blood, tumor tissue, and stool samples.",[201,35],[364,365,366,117,367,368,369,370],"Mannatide","Tislelizumab","CAPOX","Gastroesophageal Junction Cancer","Metastatic Gastric Cancer","First-Line Treatment","Phase II Study","2026-06-13",{"date":179,"type":93},{"date":90,"type":23},{"date":375,"type":23},"2029-07-01",{"name":377,"class":100},"Ming Liu",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":112,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":307},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":386,"type":23},50,[150],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[390,391,392,393,394,395,396,397,398,399,35,400,401,402,41,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Urothelial Carcinoma","Unresectable Urothelial Carcinoma","2026-06-05",{"date":421,"type":93},"2026-06-09",{"date":423,"type":93},"2024-04-30",{"date":425,"type":23},"2026-12-31",{"name":427,"class":100},"Mayo Clinic",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":20,"enrollmentInfo":435,"targetDuration":4,"studyType":112,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":307},"100632781","phase-3-a-study-comparing-bl-m05d1-with-the-investigators-choice-of-treatment-regimen-in-patients-with-claudin-cldn182-positive-advanced-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma-gcgejc-who-have-received-prior-first-line-treatment-100632781","NCT07518147","A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-Line Treatment","A Randomized Controlled Phase III Clinical Study Comparing BL-M05D1 for Injection With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN) 18.2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJC) Who Have Received Prior First-line Treatment","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;\n6. Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression;\n7. Ability to provide archived or fresh tumor tissue;\n8. Must have at least one measurable lesion as defined by RECIST v1.1;\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n12. Organ function levels must meet the requirements;\n13. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN);\n14. Urine protein ≤2+ or \\\u003C1000 mg\u002F24h;\n15. For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test negative, and must be non-lactating; all enrolled patients (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Prior anti-tumor treatment;\n2. Positive HER2 expression in tumor tissue;\n3. History of severe cardiovascular or cerebrovascular disease;\n4. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n6. Active autoimmune diseases and inflammatory diseases;\n7. Diagnosis of another malignancy within 3 years prior to the first dose;\n8. Hypertension poorly controlled by two antihypertensive medications;\n9. History of interstitial lung disease (ILD) requiring hormone therapy, etc.;\n10. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;\n11. Infection requiring clinical intervention within 2 weeks prior to randomization;\n12. Patients with poorly controlled blood glucose levels;\n13. Patients with active central nervous system metastases;\n14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;\n15. Imaging findings indicating tumor invasion or encasement of major blood vessels such as those in the chest, neck, or pharynx;\n16. History of allergic reactions to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M05D1;\n17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n19. Active infection requiring systemic treatment;\n20. Pregnant or breastfeeding women;\n21. Esophageal or gastric varices requiring intervention within the past three months, etc.;\n22. History of intestinal obstruction, inflammatory bowel disease, or extensive bowel resection, etc.;\n23. Presence of other serious physical or laboratory abnormalities, or poor compliance, which may increase the risk of participating in the study, interfere with study results, or make the patient unsuitable for participation in the study as judged by the investigator.",{"count":436,"type":23},438,[114],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC\u002FGEJC) who have received prior first-line treatment.",[117,35],"2026-06-03",{"date":442,"type":93},"2026-06-04",{"date":444,"type":93},"2026-05-15",{"date":446,"type":23},"2029-12",{"name":448,"class":137},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":112,"phases":458,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":461,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":307},"100597524","phase-2-neoadjuvant-intra-tumoral-rp2-and-flot-in-gastroesophageal-adenocarcinoma-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":457,"type":23},34,[150],"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.",[201,155,35],{"date":419,"type":93},{"date":463,"type":23},"2026-09-01",{"date":465,"type":23},"2029-11-01",{"name":467,"class":100},"Abramson Cancer Center at Penn Medicine",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":20,"enrollmentInfo":475,"targetDuration":4,"studyType":112,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":307},"100630122","phase-2-ibi343-in-combination-with-sintilimab-and-sox-regimen-for-perioperative-treatment-of-resectable-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100630122","NCT07483567","IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Randomized, Open-label, Multicenter Phase II Clinical Study to Explore the Perioperative Treatment of Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With IBI343 in Combination With Sintilimab and SOX Regimen.","Inclusion criteria\n\n1. Signed written informed consent and able to comply with the visit and related procedures as specified in the protocol.\n2. Male or female, 18 years ≤ age ≤ 75 years;\n3. ECOG score 0-1;\n4. Histologically confirmed, previously untreated patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction; only Siewert II\u002FIII type participants are allowed for gastroesophageal junction cancer;\n5. Clinical staging based on enhanced CT\u002FMRI examination, clinical stage T3\\~4a with positive lymph nodes, and no distant metastasis;\n6. The research center and surgeon can perform radical D2 lymph node dissection surgery, R0 resection;\n7. Physical condition and organ function allow for major abdominal surgery;\n8. Confirmed CLDN18.2 expression by central laboratory pathological tissue testing.\n9. Adequate organ and bone marrow function.\n10. Echocardiography confirms left ventricular ejection fraction (LVEF) ≥ 50%;\n11. Female participants must agree not to breastfeed from screening through the entire treatment period and up to 6 months after the last dose.\n12. Female participants of childbearing potential or male participants whose partners are of childbearing potential must use effective contraception from screening through the entire treatment period and up to 9 months after the last dose.\n\nExclusion criteria\n\n1. HER2 positive.\n2. Currently participating in another interventional clinical study, except for those in the follow-up phase of an interventional study.\n3. Previous use of traditional Chinese medicine, Chinese patent medicines, or immunomodulators must be ≥2 weeks before starting the study medication.\n4. Received treatment with a strong CYP3A4 inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.\n5. Received any live vaccine within 4 weeks prior to the first dose of the study drug or plans to receive any during the study period.\n6. Underwent major surgery (craniotomy, thoracotomy, laparotomy, laparoscopic resection of significant tissues or organs, or other as defined by the investigator, excluding needle biopsies) within 4 weeks prior to the first dose of the study drug, or has unhealed wounds, ulcers, or fractures.\n7. Patients who received steroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive drugs within 14 days before enrollment. However, patients are allowed to enroll if they use topical or inhaled steroids, or adrenal replacement therapy with ≤10 mg\u002Fday prednisone equivalent, without active autoimmune disease.\n8. History of interstitial lung disease, non-infectious pneumonia, severely impaired pulmonary function, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspected of having such conditions during the screening period.\n9. Presence of uncontrolled diseases, such as:\n\n   • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).\n10. Any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, etc.\n11. History of deep vein thrombosis (patients stable on anticoagulation for at least 2 weeks can be enrolled), pulmonary embolism, or any other serious venous thromboembolic event within 3 months prior to the first dose of the study drug (implantable venous port or catheter-related thrombosis, or superficial venous thrombosis, are not considered \"serious\" venous thromboembolic events).\n12. Any life-threatening bleeding event or Grade 3 or 4 gastrointestinal\u002Fvariceal bleeding event requiring transfusion, endoscopic, or surgical intervention within 3 months prior to the first dose of the study drug.\n13. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh B or more severe liver cirrhosis.\n14. Complete or partial intestinal obstruction present during the screening period or history of complete or partial intestinal obstruction within 3 months prior to the first dose of the study drug, or risk of bowel perforation (including but not limited to acute diverticulitis, history of intra-abdominal abscess) or history of inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n15. Other acute or chronic diseases or laboratory abnormalities that may result in: increased risk related to participation in the study or administration of the study drug, interference with the interpretation of study results, and participants deemed ineligible for the study by the investigator.\n16. Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer (such as leukemoid reaction, etc.), which may lead to higher medical risks and\u002For uncertainty in survival evaluation.\n17. Neurological, psychiatric, or social conditions that: affect compliance with study requirements, significantly increase the risk of adverse events, or impair the ability of the participant to provide written informed consent.\n18. History of other primary malignant tumors.\n19. Known history of immunodeficiency.\n20. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. History of allergic reactions to the drugs used in this study.\n22. Other conditions deemed unsuitable for participation in this study by the investigator.",{"count":476,"type":23},90,[150],"This study is a prospective, randomized, open, multicenter phase II clinical trial. It plans to enroll 70 participants with locally advanced gastric and gastroesophageal junction adenocarcinoma (G\u002FGEJ AC) who are assessed as suitable for D2 radical surgery and capable of R0 resection.To evaluate the clinical efficacy and tolerability of IBI343 in combination with sintilimab and SOX regimen for perioperative treatment of resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma.Enroll patients who are CLDN18.2 positive.",[480,481,35],"CLDN18.2 Positive","Primary Gastric Adenocarcinoma","2026-05-29",{"date":484,"type":93},"2026-06-02",{"date":486,"type":93},"2026-04-17",{"date":488,"type":23},"2031-06-30",{"name":490,"class":137},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":112,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":511,"locationsCount":307},"100640725","phase-2-skb315-in-combination-therapy-in-patients-with-advanced-or-metastatic-gc-gej-adenocarcinoma-100640725","NCT07609667","SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC\u002F GEJ Adenocarcinoma","A Phase II Study Evaluating the Efficacy and Safety of SKB315 Combination Therapy in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","SKB315","Inclusion Criteria:\n\n1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma\n2. No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n3. Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;\n4. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;\n6. Estimated survival ≥ 3 months as judged by the investigator;\n7. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;\n8. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;\n\nExclusion Criteria:\n\n1. Active leptomeningeal disease or uncontrolled brain metastasis\n2. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2\n3. Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;\n4. Patients with active hepatitis B or hepatitis C;\n5. Patients have significant gastric bleeding\n6. The presence of clinically uncontrollable third interspace fluid\n7. Have clinically significant systemic diseases that may adversely affect the safety of the study;\n8. Patients who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the patients are not appropriate to patients in the study.","80 Years",{"count":501,"type":23},80,[150],"This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",[35],"2026-05-20",{"date":507,"type":93},"2026-05-27",{"date":129,"type":23},{"date":510,"type":23},"2029-06-30",{"name":512,"class":137},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":20,"enrollmentInfo":520,"targetDuration":4,"studyType":112,"phases":522,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":538,"locationsCount":307},"100639029","phase-2-adaptive-adjuvant-therapy-after-neoadjuvant-therapy-and-gastrectomy-for-gastric-or-gastroesophageal-junction-adenocarcinoma-100639029","NCT07603349","Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma","Efficacy and Safety of Postoperative Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Radical Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label Clinical Trial","Key Inclusion Criteria:\n\n1. Voluntarily signed written informed consent.\n2. Aged 18 to 75 years, inclusive, regardless of sex.\n3. Underwent radical gastrectomy with D2 or more extended lymphadenectomy and achieved R0 resection. Surgical approaches may include open or laparoscopic surgery.\n4. Histopathologically confirmed gastric or gastroesophageal junction adenocarcinoma.\n5. Received preoperative neoadjuvant immunotherapy combined with chemotherapy, including oxaliplatin plus fluoropyrimidine-based chemotherapy. Immunotherapy may include anti-PD-1 monoclonal antibodies, anti-PD-L1 monoclonal antibodies, PD-1\u002FCTLA-4 bispecific antibodies, and other immune checkpoint inhibitors.\n6. Eligible for one of the following predefined cohorts:\n\n   * Cohort 1: TRG grade 3 and postoperative pathological stage ypT3-4N2-3M0.\n   * Cohort 2: TRG grade 0 and postoperative pathological stage ypT0N0M0.\n7. ECOG performance status of 0 or 1.\n8. No evidence of metastasis or recurrence on postoperative imaging before enrollment.\n9. Adequate organ function, defined as hematologic, hepatic, renal, and thyroid function meeting the protocol-specified criteria based on laboratory tests performed within 14 days before randomization.\n10. Willing and able to comply with the study treatment, scheduled visits, laboratory tests, and other study procedures.\n11. Female participants of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after the last dose of study treatment. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose of study treatment.\n\nKey Exclusion Criteria:\n\n1. Presence of liver, peritoneal, or other distant metastases.\n2. Inability to take oral medications.\n3. Unresolved postoperative complications at the time of randomization, such as postoperative infection, anastomotic leakage or wound dehiscence, gastrointestinal bleeding, pancreatic fistula, or intestinal obstruction.\n4. Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites at screening, defined as any of the following: pleural effusion or ascites with clinical symptoms and detectable by physical examination; or pleural effusion or ascites requiring drainage and\u002For intracavitary treatment during screening.\n5. Underwent any surgery requiring general anesthesia that was not related to gastric cancer within 28 days before randomization.\n6. History of or current diagnosis of another malignancy within 5 years.\n7. Active or prior autoimmune disease that may relapse or require immunosuppressive treatment within 2 weeks or during the study period; or a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disease; or a history of organ transplantation.\n8. Participation in another clinical study, or any condition that may interfere with the interpretation of the study results.\n9. Any other severe acute or chronic disease that, in the investigator's judgment, may increase the risk associated with study participation or study treatment.\n10. Active or uncontrolled infection requiring systemic antibiotic therapy within 2 weeks before randomization or at the time of randomization.\n11. Diagnosis of interstitial pneumonia, noninfectious pneumonitis, pulmonary fibrosis, or acute lung disease.\n12. Active tuberculosis within 1 year or previous anti-tuberculosis treatment.\n13. Female participants who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after the end of treatment.\n14. History of psychotropic drug abuse with inability to discontinue, or presence of a psychiatric disorder.\n15. Patients considered unsuitable for participation in this study by the investigator.",{"count":521,"type":23},405,[150,114],"The goal of this clinical trial is to evaluate postoperative adaptive adjuvant therapy in patients with gastric or gastroesophageal junction adenocarcinoma after neoadjuvant chemotherapy plus immunotherapy and radical gastrectomy.The main questions it aims to answer are:\n\n1. In patients with poor pathological response, does switching to a alternative postoperative treatment regimen improve survival?\n2. In patients with complete pathological response, can observation without routine postoperative treatment maintain favorable survival outcomes? Participants will be assigned to different cohorts according to their pathological response after surgery and will be followed regularly for recurrence, survival, and treatment-related side effects.",[201,35],[526,527,528,529,530,531],"Gastric cancer","Gastroesophageal junction cancer","Neoadjuvant therapy","Adaptive adjuvant therapy","Pathological response","Prognosis","2026-05-18",{"date":534,"type":93},"2026-05-22",{"date":536,"type":23},"2026-06",{"date":446,"type":23},{"name":539,"class":100},"Nanfang Hospital, Southern Medical University",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":112,"phases":549,"briefSummary":550,"conditions":551,"keywords":562,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":586},"100392410","phase-1-a-study-of-sigvotatug-vedotin-in-advanced-solid-tumors-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":548,"type":23},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.",[552,553,554,555,155,35,556,557,558,559,560,561],"Carcinoma, Non-Small Cell Lung","Squamous Cell Carcinoma of Head and Neck","HER2 Negative Breast Neoplasms","Esophageal Squamous Cell Carcinoma","Ovarian Neoplasms","Cutaneous Squamous Cell Cancer","Exocrine Pancreatic Adenocarcinoma","Urinary Bladder Neoplasms","Uterine Cervical Neoplasms","Stomach Neoplasms",[563,564,565,566,567,568,569,570,571,572,573,118,574,575,117,576],"NSCLC","HNSCC","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","Bladder Cancer","Cervical Cancer","Seattle Genetics","2026-05-08",{"date":579,"type":93},"2026-05-11",{"date":581,"type":93},"2020-06-08",{"date":583,"type":23},"2029-03-22",{"name":585,"class":137},"Seagen, a wholly owned subsidiary of Pfizer",159,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":112,"phases":595,"briefSummary":596,"conditions":597,"keywords":598,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":611},"100542272","phase-2-study-of-suratadenoturev-obp-301-in-combination-with-pembrolizumab-in-esophagogastric-adenocarcinoma-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":212,"type":23},[150],"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.",[155,201,35],[599,600,601],"Pembrolizumab","OBP-301","Immunotherapy","2026-04-21",{"date":604,"type":93},"2026-04-23",{"date":606,"type":93},"2024-04-25",{"date":608,"type":23},"2030-04",{"name":610,"class":100},"Weill Medical College of Cornell University",2,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":112,"phases":621,"briefSummary":622,"conditions":623,"keywords":628,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":640},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":620,"type":23},914,[149],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[624,625,561,626,35,627],"Colorectal Neoplasms","Carcinoma, Non-Small-Cell Lung","Pancreatic Ductal Adenocarcinoma","Small Cell Lung Carcinoma",[629,563,630,631,568,632,576],"CRC","PDAC","GC","SCLC",{"date":634,"type":93},"2026-04-20",{"date":636,"type":93},"2023-11-20",{"date":638,"type":23},"2030-09-12",{"name":585,"class":137},44,{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":112,"phases":650,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":307},"100409709","phase-1-nbtxr3-chemotherapy-and-radiation-therapy-for-the-treatment-of-esophageal-cancer-100409709","NCT04615013","NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer","A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus","Inclusion Criteria:\n\n* Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction\n* Adenocarcinoma of the esophagus stages II-III allowed\n* Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:\n\n  * Oxaliplatin and fluorouracil (5-FU) or capecitabine\n  * Docetaxel and\u002For 5-FU or paclitaxel\n  * Carboplatin and paclitaxel\n* Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician\n\n  * Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion\n* Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \\[RECIST\\] version \\[v\\] 1.1) at the same anatomical location should be achievable\n\n  * Local nodal disease around the esophagus allowed\n  * Nodal target lesions must be \\>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Hemoglobin \\>= 8.0 g\u002FdL\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN)\n* Calculated (Calc.) creatinine clearance \\> 30 mL\u002Fmin\n* Glomerular filtration ratio \\> 40 mL\u002Fmin per 1.73 m\\^2\n* Total bilirubin =\\\u003C 2.0 mg\u002FdL\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN)\n* Negative urine or serum pregnancy test =\\\u003C 7 days of NBTXR3 injection in all female participants of child-bearing potential\n* Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Prior radiation or any therapy for the treatment of esophageal cancer\n* Prior surgical resection of esophageal tumor\n* Esophageal cancer with radiographic evidence of metastases at screening\n* At screening, past medical history of:\n\n  * Esophageal fistula\n  * Tracheoesophageal fistula\n  * Siewert type III tumors\n* Evidence of bulky disease and\u002For abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician\n\n  * Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed\n* Known uncontrolled (grade \\>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment\n* Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast\n* Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment\n* Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Female patients who are pregnant or breastfeeding\n* Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \\\u003C 1% per year when used consistently and correctly\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":649,"type":23},24,[149],"The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.",[653,654,655,656,657,35,658,659,660,661,662,663,664],"Cervical Esophagus Adenocarcinoma","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8","Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Pathologic Stage II Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage III Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8","Thoracic Esophagus Adenocarcinoma","2026-04-13",{"date":667,"type":93},"2026-04-16",{"date":669,"type":93},"2020-11-23",{"date":671,"type":23},"2027-10-31",{"name":673,"class":100},"M.D. Anderson Cancer Center",{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":4,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":112,"phases":683,"briefSummary":684,"conditions":685,"keywords":693,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":714,"lastUpdatePostDateStruct":715,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":721,"locationsCount":723},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":682,"type":23},310,[149],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[686,574,417,687,688,689,690,118,35,555,155,691,692],"Advanced\u002FMetastatic Solid Tumors","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Pancreatic Adenocarcinoma","Pancreatic Cancer",[694,695,696,697,698,699,700,563,701,564,702,703,704,705,706,707,630,708,709,710,711,712,713],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","head and neck cancer","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6","2026-04-06",{"date":716,"type":93},"2026-04-07",{"date":718,"type":93},"2025-08-20",{"date":720,"type":23},"2029-07-08",{"name":722,"class":137},"Pfizer",28,{"id":725,"slug":726,"hasResults":12,"nctId":727,"briefTitle":728,"officialTitle":729,"acronym":4,"eligibilityCriteria":730,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":499,"enrollmentInfo":731,"targetDuration":4,"studyType":112,"phases":733,"briefSummary":734,"conditions":735,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":737,"lastUpdatePostDateStruct":738,"startDateStruct":740,"completionDateStruct":742,"leadSponsor":744,"locationsCount":307},"100497135","phase-2-robotic-cytoreduction-and-hyperthermic-intraperitoneal-chemotherapy-for-treatment-of-gastric-cancer-with-limited-peritoneal-metastasis-robo-chip-study-100497135","NCT05753306","Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study","A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial","Inclusion Criteria:\n\n* Restricted to 18 to 80 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II\u002FIII gastroesophageal (GE) junction adenocarcinomas\n* Absolute neutrophil count \\>= 1,500 \u002F uL\n* Platelets \\>= 50,000 \u002F Ul\n* Serum creatinine \\\u003C= 1.5 mg \u002F dL\n* Adequate nutritional status (Albumin \\>= 3.5)\n* Metastasis confined to the peritoneum:\n\n  * Positive peritoneal cytology\n  * Peritoneal metastasis on diagnostic laparoscopy\n  * Peritoneal metastasis on imaging\n* Response to systemic chemotherapy defined as at least one of the following:\n\n  * Reduction (\\>= 30%) in standardized uptake value (SUV) max \\[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\\]\n  * Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\\>= 20% decrease in the longest diameter of target lesion) RECIST criteria\n  * Reduction ( \\>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology\n  * Reduction ( \\>= 30%) in serum tumor markers CEA or CA 19-9\n* Peritoneal Carcinomatosis Index (PCI) =\\\u003C 7 and surgeon deems high likelihood for a complete cytoreduction\n* Body Mass Index (BMI) =\\\u003C 35 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)\n* Malignant ascites at time of study enrollment\n* Comorbidities that would preclude protocol therapy\n* Subjects deemed unable to comply with study and\u002For follow-up procedures\n* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity",{"count":732,"type":23},40,[150],"This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.",[201,35,736],"Metastatic Malignant Neoplasm in the Peritoneum","2026-04-02",{"date":739,"type":93},"2026-04-08",{"date":741,"type":93},"2023-04-20",{"date":743,"type":23},"2030-03-25",{"name":427,"class":100},{"id":746,"slug":747,"hasResults":12,"nctId":748,"briefTitle":749,"officialTitle":750,"acronym":751,"eligibilityCriteria":752,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":753,"targetDuration":4,"studyType":112,"phases":755,"briefSummary":756,"conditions":757,"keywords":759,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":764,"lastUpdatePostDateStruct":765,"startDateStruct":767,"completionDateStruct":769,"leadSponsor":771,"locationsCount":773},"100564371","phase-2-a-study-to-evaluate-the-adverse-events-efficacy-and-optimal-dose-of-intravenous-iv-abbv-400-in-combination-with-iv-fluorouracil-leucovorin-and-budigalimab-in-adult-participants-with-locally-advanced-unresectable-or-metastatic-gastric-gastroesophageal-junction-or-esophageal-adenocarcinoma-100564371","NCT06628310","A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma","A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)","AndroMETa-GEA","Inclusion Criteria:\n\n* Have inoperable, advanced or metastatic histologically- or cytologically confirmed gastric, gastroesophageal junction, or esophageal adenocarcinoma.\n* Have measurable disease determined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Human epidermal growth factor receptor 2 (HER2) negative disease, defined as immunohistochemistry (IHC) (0, or 1+) or fluorescence in situ hybridization (FISH) negative.\n* Known programmed death ligand 1 (PD-L1) status at screening, or availability of tumor tissue for central PD-L1 testing prior to enrollment.\n\nExclusion Criteria:\n\n* Have prior systemic therapy in the locally advanced, unresectable, or metastatic setting.\n* History of clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.",{"count":754,"type":23},180,[150],"Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan (ABBV-400) is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor Budigalimab. The combination (AFLB) will be given to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA).\n\nTelisotuzumab Adizutecan (ABBV-400) and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive Budigalimab and FOLFOX (Fluorouracil, Leucovorin, and Oxaliplatin) . A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide.\n\nIn the dose escalation stage, participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan (ABBV-400) within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage, participants will receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[758,35,155],"Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma",[758,35,155,760,761,762,763],"ABBV-400","ABBV-181","Budigalimab","Telisotuzumab Adizutecan","2026-03-26",{"date":766,"type":93},"2026-03-30",{"date":768,"type":93},"2024-12-13",{"date":770,"type":23},"2030-10",{"name":772,"class":137},"AbbVie",49]