[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-gastric-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-gastric-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,56,67,88,122,158,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053222","phase-2-adding-nivolumab-to-usual-treatment-for-people-with-advanced-stomach-or-esophageal-cancer-paramune-trial-100053222",false,"NCT06203600","Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial","Randomized Phase II\u002FIII Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >\u002F= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)","Inclusion Criteria:\n\n* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma\n* Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen\n* Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma\n* Participants must have documented unresectable and\u002For metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration\n* Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1\u002FPD-L1 inhibitor cycle\n* Participants must not have received more than one prior line of systemic therapy defined as chemotherapy plus either nivolumab, pembrolizumab, or any other PD-1 or PD-L1 inhibitor, in the stage IV or unresectable setting. Peri-operative or adjuvant nivoluamb or other PD-1\u002FPD-L1 inhibitors would count as one prior line of systemic therapy if patients progressed while on nivolumab (or other PD-1\u002FPD-L1 inhibitors) or within 6 months of stopping it\n\n  * Note: Radiation or any other regional therapy options done to address local residual disease or metastatic disease would not count as a line of therapy. Maintenance therapy with a different form of fluoropyrimidine (i.e. switching from capecitabine to fluorouracil \\[5FU\\]) would not count as another line of therapy\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \\\u003C 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration\n* Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible\n* Participants must not have received a live attenuated vaccination within 28 days prior to registration\n* Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration\n* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded\n* Participants must not have plans to undergo elective or planned major surgery during the clinical trial\n* Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy\n* Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements\n* Participants must be ≥ 18 years old\n* Participants must have Zubrod Performance Status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 2 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.2 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Hemoglobin ≥ 9.0 g\u002FdL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN)\n* Participants must have a calculated creatinine clearance ≥ 40 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \\\u003C 1000 mg of protein in 24 hours to allow participation in the study\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better\n* Participants must have recovered to baseline or \\\u003C grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy\n* Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration\n* Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed\n* Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","ALL","18 Years",{"count":19,"type":20},224,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This phase II\u002FIII trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Advanced Esophageal Adenocarcinoma","Advanced Gastric Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Esophageal Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Esophageal Adenocarcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Unresectable Esophageal Adenocarcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":47},"2024-06-24",{"date":51,"type":20},"2027-10-31",{"name":53,"class":54},"National Cancer Institute (NCI)","NIH",372,{"id":57,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":25,"conditions":60,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":55},"100531730",{"count":19,"type":20},[23,24],[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"2026-07-01",{"date":63,"type":47},"2026-07-02",{"date":49,"type":47},{"date":51,"type":20},{"name":53,"class":54},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100491312","phase-3-mfolfirinox-versus-mfolfox-with-or-without-nivolumab-for-the-treatment-of-advanced-unresectable-or-metastatic-her2-negative-esophageal-gastroesophageal-junction-and-gastric-adenocarcinoma-100491312","NCT05677490","mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma","Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology \\[JCO\\] 2017) with known PD-L1 CPS (Any CPS is allowed, but should be known prior to registration)\n* Stage: unresectable or metastatic\n* Tumor site: esophagus, gastroesophageal junction, or stomach\n* Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* No prior treatment for unresectable or metastatic disease\n* Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\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) OR calculated (calc.) creatinine clearance \\>= 30 mL\u002Fmin\n* Total bilirubin =\\\u003C 1.5 x ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x ULN (in patients with liver metastasis: =\\\u003C 5 x ULN if clearly attributable to liver metastases)\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* Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:\n\n  * On effective anti-retroviral therapy\n  * Undetectable HIV viral load by standard clinical assay =\\\u003C 6 months of 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 2B or better\n* Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors\n\n  * Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)\n  * Patients must not have a condition requiring systemic treatment with either corticosteroids (\\>10mg\u002Fday prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=\\\u003C 10mg\u002Fday prednisone equivalent) are permitted\n  * Patients must not have a history of noninfectious pneumonitis requiring steroids\n  * Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible\n* This study includes the use of the mandatory patient completed measure, PRO-CTCAE. For this study the PRO-CTCAE is available in English, Spanish, Korean, Chinese (Simplified), and Russian, hence patients must be able to speak, understand and read in these languages. Ad-hoc translation of patient-reported measures is not permitted\n\nExclusion Criteria:\n\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  \\* Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\\\u003C 7 days prior to registration is required\n* No known Gilbert's syndrome or known homozygosity for UGAT1A1\\*28 polymorphism\n* No baseline grade \\>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality\n* No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\n* No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks\n* No allogeneic tissue\u002Forgan transplant",{"count":75,"type":20},382,[24],"This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.",[27,28,29,31,32,33,34,35,36,37,38,39,40,41,42],{"date":63,"type":47},{"date":81,"type":47},"2023-01-31",{"date":83,"type":20},"2028-11-08",{"name":85,"class":86},"Alliance for Clinical Trials in Oncology","OTHER",794,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100581133","phase-2-testing-ivonescimab-in-combination-with-chemotherapy-in-advanced-or-metastatic-gastricgastroesophageal-adenocarcinoma-100581133","NCT06846346","Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric\u002FGastroesophageal Adenocarcinoma","Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients","GRACIE","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.\n2. Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC)\n3. Metastatic or locally advanced non resectable (stage IV) disease.\n4. Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Age ≥18 years.\n7. For patients without actionable biomarker (HER2 and Claudin 18.2-negative) except for PD-L1, no prior treatment for advanced disease (cohort 1). For patients with at least one of the following actionable biomarker (PD-L1 CPS≥1, and\u002For HER2-positive, and\u002For Claudin 18.2-positive), who had received only one prior line of treatment for advanced disease (cohort 2).\n8. Adequate hematological function: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and hemoglobin ≥9 g\u002FdL. Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening hematology analysis.\n9. Adequate renal function: estimated creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula, or estimated glomerular filtration rate (eGFR) value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g.\n10. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (≤3 x ULN for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis).\n11. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy).This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose.\n12. Women of childbearing potential (WOCBP) having sex with an unsterilized male partner and unsterilized males having sex with a female partner of childbearing potential, must agree to use an effective method of contraception for the duration of trial participation and as required after completing study treatment (120 days after the last dose of ivonescimab). Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n13. WOCBP must have a negative serum pregnancy test performed within 3 days before inclusion and a negative urine pregnancy test on the day of first dose, prior to treatment administration.\n14. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures\n15. Affiliation to the Social Security System (or equivalent)\n\nExclusion Criteria:\n\n1. Previous or concurrent cancer that is distinct in primary site or histology from gastroesophageal cancer within 2 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\\].\n2. Patients with high microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor.\n3. Enteral intake \\\u003C 1500 kcal \u002Fd and or a weight loss \\> 15% of total body weight within the 6 months\n4. Toxicities from previous treatment not resolved to grade ≤ 1 (according to the version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before treatment start with the exception of alopecia.\n5. Major surgical procedures or serious trauma within 4 weeks prior to treatment start, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to treatment start.\n6. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to inclusion, including but not limited to:\n\n   1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots), Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n   2. Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed),\n   3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to treatment start is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n7. Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n8. History of major diseases before inclusion, specifically:\n\n   1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to inclusion, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia),\n   2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before inclusion,\n   3. History of any grade arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in NCI-CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to inclusion,\n   4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before inclusion,\n   5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to inclusion.\n9. Imaging during the screening period shows that the patient has:\n\n   1. Radiologically documented evidence of major blood vessel invasion or encasement by cancer,\n   2. Radiographic evidence of intra-tumor cavitation.\n   3. Evidence of higher bleeding risk on prostheses\n10. Any immunosuppressive therapy during more than 7 days (i.e. corticosteroids \\>10mg or equivalent dose) within 14 days before the planned start of study therapy. Physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency is not considered as a form of systemic treatment.\n11. Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,\n    2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,\n    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    I. Rash must cover \\\u003C 10% of body surface area, II. Disease is well controlled at baseline and requires only low-potency topical corticosteroids, III. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.\n12. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n13. Known history of, or any evidence of, interstitial lung disease.\n14. Patient with non-controlled human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) infection (patient with undetectable viral load (HIV RNA PCR) and CD4 above 350 either spontaneously or on stable anti-viral regimen).\n15. Chronic hepatitis B or C infection (if hepatitis status cannot be obtained from medical records, re-testing is required)\n16. In case of planned treatment with fluorouracil, proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).\n17. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.\n18. Pregnant or breast-feeding females.\n19. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.\n20. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n21. Individuals deprived of liberty or placed under protective custody or guardianship",{"count":97,"type":20},88,[23],"The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.",[37,27,38,28],[102,103,104,105,106,107,108,109,110,111],"Ivonescimab","Esophageal","Gastric","Adenocarcinoma","Cancer","Metastatic","Advanced","FOLFOX","Irinotecan","Paclitaxel","2026-04-22",{"date":114,"type":47},"2026-04-28",{"date":116,"type":47},"2025-11-20",{"date":118,"type":20},"2028-09",{"name":120,"class":86},"UNICANCER",4,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":157},"100635336","phase-1-dual-target-cldn182her2-car-nk-cells-for-advanced-gastricgej-cancer-100635336","NCT07551362","Dual-target CLDN18.2\u002FHER2 CAR-NK Cells for Advanced Gastric\u002FGEJ Cancer","A Phase 1\u002F2, Open-label, Multicenter Study of Allogeneic Dual-target CLDN18.2\u002FHER2 (ERBB2) CAR-NK Cells After Fludarabine\u002FCyclophosphamide Lymphodepletion in","DUET-GEJ","Inclusion Criteria:\n\n* Signed informed consent before any study-specific procedure.\n* Age 18 to 75 years.\n* Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.\n* Central confirmation of CLDN18.2-positive disease by immunohistochemistry, defined for this draft as membranous CLDN18.2 expression in at least 10% of tumor cells. HER2 testing is required for all subjects; HER2-positive disease is defined as IHC 3+ or IHC 2+\u002FISH+ using gastric\u002FGEJ testing criteria.\n* Disease progression after at least 2 prior systemic regimens for advanced disease, including a fluoropyrimidine and platinum agent unless contraindicated or not tolerated. If HER2-positive, prior HER2-directed therapy is expected unless unavailable, contraindicated, or not tolerated.\n* At least 1 measurable lesion according to RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Life expectancy of at least 12 weeks.\n* Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.\n* Recovery of prior treatment-related toxicities to Grade 1 or baseline, except alopecia or stable endocrine replacement therapy.\n* Willingness to provide archival tumor tissue or fresh biopsy material if archival tissue is inadequate for central biomarker confirmation.\n* Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during the protocol-defined period\n\nExclusion Criteria:\n\n* Prior CLDN18.2-targeted or HER2-targeted genetically modified cell therapy (CAR-T, CAR-NK, TCR-T, or similar).\n* Active or untreated central nervous system metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled HBV, HCV, or HIV viremia.\n* Active autoimmune disease requiring systemic immunosuppression.\n* Clinically significant uncontrolled cardiovascular disease, including recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or severe heart failure.\n* Active gastrointestinal perforation, uncontrolled upper GI bleeding, clinically significant bowel obstruction, or unstable gastric ulcer.\n* History of solid-organ transplantation or prior allogeneic hematopoietic stem-cell transplantation with active graft-versus-host disease.\n* Requirement for systemic corticosteroids above physiologic replacement (for example, \\>10 mg\u002Fday prednisone equivalent) within 7 days before lymphodepletion.\n* Pregnancy or breastfeeding.\n* Another active malignancy requiring systemic therapy, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or other protocol-allowed low-risk malignancies.\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, would make study participation unsafe or would interfere with interpretation of study results.","75 Years",{"count":132,"type":20},36,[134,23],"PHASE1","This example planning study proposes a phase 1\u002F2 evaluation of an allogeneic, cord-blood-derived dual-target CAR-NK product directed against CLDN18.2 and HER2 (ERBB2) in adults with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma after prior standard systemic therapy. CLDN18.2 is selected as the anchor antigen because it has the more disease-specific gastric\u002FGEJ cell-therapy development footprint, while HER2 is retained as the complementary second antigen to address co-expressing or heterogeneous disease. Phase 1 uses a 3+3 dose-escalation design after fludarabine\u002Fcyclophosphamide lymphodepletion followed by three intravenous CAR-NK infusions on Days 0, 3, and 7. Phase 2 expansion evaluates the recommended phase 2 dose and preliminary antitumor activity",[28,29],[138,139,140,141,142,143,144,145,146],"Solid tumor immunotherapy","Gastric cancer","GEJ cancer","Adoptive cellular immunotherapy","CAR-NK","Allogeneic NK cell therapy","CLDN18.2","HER2","ERBB2","2026-04-18",{"date":149,"type":47},"2026-04-24",{"date":151,"type":47},"2026-03-02",{"date":153,"type":20},"2028-03-17",{"name":155,"class":156},"Beijing Biotech","INDUSTRY",1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":157},"100442420","early-phase-1-pembrolizumab-and-lenvatinib-for-the-treatment-of-advanced-unresectable-or-metastatic-gastroesophageal-adenocarcinoma-100442420","NCT05041153","Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma","A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* The subject (or legally acceptable representative if applicable) provides written informed consent for the trial\n* Male and female subjects who are at least 18 years of age on day of signing informed consent with histologically and cytologically documented diagnosis as gastric or gastroesophageal adenocarcinoma\n* Has a documented, previously treated, advanced (unresectable and\u002For metastatic) gastroesophageal adenocarcinoma that is incurable and for which prior first-line or later-line standard of care (SOC) treatments have failed. Prior neoadjuvant or adjuvant therapy included in initial treatment may not be considered first- or later-line SOC treatment unless such treatments were completed less than 12 months prior to the current tumor recurrence\n* Has submitted an evaluable tissue sample for biomarker analysis from a newly obtained irradiated. The tumor tissue submitted for analysis must be from a single tumor tissue specimen and of sufficient quantity and quality to allow biomarker study (see laboratory manual). A \"newly obtained\" tumor specimen, defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1, for biomarker characterization will be required for enrollment of all subjects. Tissue from tumor progressing at a site of prior radiation (at least 6 weeks interval after last radiation) may be allowed for biomarker characterization upon agreement from Merck. Subjects for whom newly-obtained samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Merck\n* Has measurable disease based on RECIST 1.1 as assessed by the Investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale within 5 days of starting study treatment\n* Has a life expectancy of greater than 3 months per the judgment of the investigators\n* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =\\\u003C 150\u002F90 mm Hg at screening and no change in antihypertensive medications within 1 week of cycle 1 day 1\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FuL (specimens must be collected within 5 days prior to the start of study treatment)\n* Platelets \\>= 100,000\u002FuL (specimens must be collected within 5 days prior to the start of study treatment)\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL without transfusion or EPO dependency (within 7 days of assessment) (specimens must be collected within 5 days prior to the start of study treatment)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional ULN (specimens must be collected within 5 days prior to the start of study treatment)\n\n  * Creatinine clearance should be calculated per institutional standard\n* Total bilirubin \\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 x ULN (specimens must be collected within 5 days prior to the start of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN OR =\\\u003C 5 x ULN for subjects with liver metastases (specimens must be collected within 5 days prior to the start of study treatment)\n* Albumin \\>= 2.5 mg\u002FdL (specimens must be collected within 5 days prior to the start of study treatment)\n* International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 5 days prior to the start of study treatment)\n* Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib\n\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n  * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n    * Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a women of child birth potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n  * Please note that 30 days after lenvatinib is stopped, if the subject is on pembrolizumab only, no male contraception measures are needed\n* A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a WOCBP OR\n  * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) and has a low user dependency, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 12.8 during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention\n  * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n  * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n  * Note: Subjects who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* Has had major surgery within 3 weeks prior to first dose of study interventions.\n\n  * Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility\n* Has preexisting \\>= grade 3 gastrointestinal or non-gastrointestinal fistula\n* Has urine protein \\>= 1 g\u002F24 hours.\n\n  * Note: subjects with proteinuria \\>= 2+ (\\>= 100 mg\u002FdL) on urine dipstick testing\u002Furinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria\n* Has significant gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n\n  * Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy\n* Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug\n* Significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability\n* Prolongation of corrected QT (QTc) interval to \\> 480 ms\n* Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO)\n* Has known intolerance or severe hypersensitivity (grade \\>= 3) to pembrolizumab, lenvatinib, or any of their excipients\n* Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, a VEGFR2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 times the half-life time, whichever is shorter prior to allocation.\n\n  * Note: Subjects must have recovered from all adverse events (AEs) due to previously therapies to =\\\u003C grade 1 or baseline. Subjects with =\\\u003C grade 2 neuropathy may be eligible\n* Has received prior radiotherapy within 2 weeks prior to study day 1.\n\n  * Note: Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Has a known additional malignancy that is progressing or requires active treatment.\n\n  * Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiological stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible\n* Has a history of (non-infectious) pneumonitis that required treatment with steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance-abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Had an allogenic tissue\u002Fsolid organ or hematologic transplant\n* Has a known history of hepatitis B virus (HBV; hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed",{"count":166,"type":20},15,[168],"EARLY_PHASE1","This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced\u002Fmetastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.",[28,29,32,33,35,36,171,172,173,174,38,39,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,41,42],"Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage III Gastric Cancer AJCC v8","Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIA Gastric Cancer AJCC v8","Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIB Gastric Cancer AJCC v8","Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIC Gastric Cancer AJCC v8","Pathologic Stage IV Gastric Cancer AJCC v8","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","2026-01-09",{"date":196,"type":47},"2026-01-12",{"date":198,"type":47},"2022-02-14",{"date":200,"type":20},"2026-12-30",{"name":202,"class":86},"M.D. Anderson Cancer Center",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":231,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100518299","phase-2-total-neoadjuvant-flot-chemotherapy-in-locally-advanced-gastric-and-gastroesophageal-junction-cancer-100518299","NCT06028737","Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer","Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2\u002F3","OCTASUR","Inclusion Criteria:\n\n* Tumor spread according to TNM: ≥cT3 and\u002For ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);\n* Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;\n* Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2\u002F3) adenocarcinoma.\n* Differentiation grade: G0 - G4;\n* Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;\n* Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen;\n* Patient agrees to participate in this biomedical study.\n\nExclusion Criteria:\n\n* Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.\n* Comorbidities or patient conditions that preclude the administration of chemotherapy.","80 Years",{"count":213,"type":20},150,[23,24],"The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:\n\n1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery.\n2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.",[217,218,219,220,221,28,222,223,224,29,225,226,227,228,229,230],"Gastric Cancer","Stomach Cancer","GastroEsophageal Cancer","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Gastric Neoplasm","Stomach Neoplasm","Gastrointestinal Cancer","Advanced Gastric Carcinoma","Chemotherapy","Gastrectomy","Gastrectomy for Gastric Cancer","Gastric Resection","Gastric (Cardia, Body) Cancer",[232,233,234,227,235,236,237,238,139],"Total neoadjuvant chemotherapy","FLOT","Fluoruracil","Perioperative chemotherapy","Docetaxel","Leucovorin","Gastric resection","2025-04-30",{"date":241,"type":47},"2025-05-06",{"date":243,"type":47},"2025-03-25",{"date":245,"type":20},"2032-12-31",{"name":247,"class":86},"Ukrainian Society of Clinical Oncology",2]