[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-gastroesophageal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-gastroesophageal-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100635579","phase-2-a-study-to-evaluate-efficacy-and-safety-of-tislelizumab-plus-chemotherapy-for-locally-advanced-unresectable-or-metastatic-gastric-or-gastroesophageal-adenocarcinoma-and-esophageal-squamous-cell-carcinoma-in-racial-and-ethnic-minority-patients-in-the-united-states-100635579",false,"NCT07554521","A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States","An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients","Inclusion Criteria:\n\n* Self-identifies as a member of racial and\u002For ethnic minority populations as defined by the Food and Drug Administration (FDA), such as Black or African American, Hispanic or Latino, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander\n* Histologically confirmed, locally advanced unresectable or metastatic gastric or gastroesophageal adenocarcinoma (GAC\u002FGEA) or esophageal squamous cell carcinoma (ESCC)\n* No previous systemic therapy for locally advanced unresectable or metastatic GAC\u002FGEA or ESCC\n* At least 1 measurable lesion per RECIST v1.1 as determined by investigator assessment\n* Patients must have positive tumor programmed death-ligand 1 (PD-L1) expression. Documented PD-L1 results are acceptable\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1\n* Adequate organ function as indicated by the following laboratory values ≤ 14 days prior to study treatment\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 and ≥ 180 days after the last dose of chemotherapy, and have a negative urine or serum pregnancy test ≤ 7 days prior to study treatment\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 and ≥ 180 days after the last dose of chemotherapy\n\nExclusion Criteria:\n\n* Patient has squamous cell or undifferentiated or other histological type gastric cancer\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 study treatment.\n* Patients with evidence of esophageal\u002Fbronchial or esophageal\u002Faorta fistula, or complete esophageal obstruction not amenable to treatment.\n* Diagnosed with GAC\u002FGEA with positive human epidermal growth factor receptor 2 (HER2). Results of the tumor HER2 testing must be known prior to study treatment\n* Active autoimmune diseases or history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and may proceed to further screening:\n\n  1. Controlled Type I diabetes\n  2. Hypothyroidism (provided it is managed with hormone replacement therapy only)\n  3. Controlled celiac disease\n  4. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)\n  5. Any other disease that is not expected to recur in the absence of external triggering factors\n* Any active malignancy ≤ 2 years before study treatment, with the exception of the specific cancer under investigation in this trial or any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to study treatment (the cytological confirmation of any effusion is permitted)\n* Have clinically significant bleeding (Common Terminology Criteria for Adverse Events (CTCAE) ≥ Grade 2) from the GI tract within 1 month prior to study treatment\n* Have a history of gastrointestinal (GI) perforation (CTCAE ≥ Grade 2) and\u002For fistulae (including prior gastric fistula operation) within 6 months prior to study treatment\n* Have a clinically significant bowel obstruction (CTCAE ≥ Grade 2)\n* Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before study treatment.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to characterize the clinical effects of tislelizumab, including pharmacokinetics (PK), activity, and safety assessments in US racial and ethnic minority patients with human epidermal growth factor receptor 2 (HER2)-negative, programmed death-ligand 1(PD-L1)-positive, unresectable or metastatic gastric or gastroesophageal cancer (GAC\u002FGEA) or esophageal squamous cell carcinoma (ESCC). The study duration will be up to approximately 6 years.",[26,27,28],"Advanced Unresectable Gastric Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Advanced Gastroesophageal Adenocarcinoma","RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":33},"2026-04-30",{"date":37,"type":20},"2031-12-31",{"name":39,"class":40},"BeOne Medicines","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100470238","phase-1-rc48-adc-combined-with-s-1-for-first-line-treatment-of-advanced-gastroesophageal-adenocarcinoma-with-moderate-expression-of-her2-100470238","NCT05403242","RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2","A Multicenter, Open Label，Single Arm，Phase Ib\u002FII Study to Evaluate the Effect and Safety of RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2","Inclusion Criteria:\n\n* At the same time, patients voluntarily participated in the study and signed informed consent;\n* Either male or female, aged 18 or older;\n* Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;\n* No previous systemic therapy; Or had received neoadjuvant\u002Fadjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;\n* HER2 IHC 2+ and FISH-;\n* ECOG scores 0-1;\n* Estimated survival ≥3 months;\n* Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;\n* Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.\n\nExclusion Criteria:\n\n* Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and\u002For the effective removal of cervical cancer in situ and\u002For except breast cancer;\n* Known hypersensitivity to RC48-ADC;\n* HBV DNA\\>500 IU\u002F mL (or 2000 copies \u002Fml), HCV RNA\\>103 copies \u002Fml, HBsAg+ and anti-HCV antibody positive;\n* History of HIV infection;\n* History of receiving any anti-cancer drug\u002Fbiologic treatment within 4 weeks prior to trial treatment;\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.",{"count":49,"type":20},42,[51,23],"PHASE1","This study was a single-arm, open, multi-center Phase Ib\u002FII clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.",[28],"2024-01-04",{"date":56,"type":33},"2024-01-08",{"date":58,"type":33},"2022-09-20",{"date":60,"type":20},"2026-09",{"name":62,"class":63},"Chinese PLA General Hospital","OTHER",3]