[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extrahepatic-cholangiocarcinoma-and-gallbladder-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extrahepatic-cholangiocarcinoma-and-gallbladder-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100642039","phase-2-efficacy-and-safety-of-postoperative-concurrent-chemoradiotherapy-for-extrahepatic-cholangiocarcinoma-and-gallbladder-carcinoma-a-multicenter-prospective-phase-ii-study-100642039",false,"NCT07636824","Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study","Inclusion Criteria:\n\n* Aged 18-80 years\n* Underwent curative resection for newly diagnosed disease, with postoperative pathology confirming extrahepatic cholangiocarcinoma or gallbladder adenocarcinoma\n* Postoperative pathology with ≥1 high-risk factor for recurrence\n\n  1. Narrow resection margin (\\\u003C1 cm), including R1 resection\n  2. Positive circumferential resection margin\n  3. T stage ≥ T3-4\n  4. Positive regional lymph nodes\n* Postoperative liver function: Child-Pugh grade A5-B7\n* No recurrence or metastasis before postoperative radiotherapy\n* ECOG performance status 0-2\n* Expected survival \\>3 months\n* Routine blood tests: Neutrophils ≥1.0×10⁹\u002FL, hemoglobin ≥80 g\u002FL, platelets ≥100×10⁹\u002FL\n* Liver function: Total bilirubin \\\u003C1.5×upper limit of normal (ULN), plus one of the following:\n\n  1. ALT and AST ≤2.5×ULN\n  2. ALT ≤1.5×ULN and AST ≤6×ULN (excluding AST elevation due to myocardial infarction)\n* Renal function: Creatinine and blood urea nitrogen ≤2.5×ULN\n* Voluntary participation and signed informed consent\n\nExclusion Criteria:\n\n* History of other malignant tumors (except papillary thyroid carcinoma, basal cell carcinoma of the skin, and cervical carcinoma in situ)\n* Severe comorbidities (e.g., myocardial infarction, arrhythmia, psychiatric disorders)\n* Prior abdominal radiotherapy\n* Post-organ transplantation\n* Symptomatic moderate-severe ascites within 4 months postoperatively\n* ≥4 months since surgery","ALL","18 Years","80 Years",{"count":19,"type":20},92,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multicenter, open-label, single-arm, prospective Phase II clinical trial. The study enrolls patients with extrahepatic cholangiocarcinoma or gallbladder carcinoma who have undergone curative resection and harbor high-risk recurrence factors, including: 1) narrow resection margin (including R1 resection); 2) positive circumferential resection margin; 3) T stage ≥ T3-4; 4）positive regional lymph nodes. All patients will receive postoperative concurrent chemoradiotherapy (CCRT) with intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). The high-risk volumes of the primary tumor bed and metastatic lymph node beds will be irradiated to 48-60 Gy in 20-25 fractions. Retroperitoneal and intra-abdominal lymph nodes will receive 50-57.5 Gy in 20-25 fractions, and lymphatic drainage regions will be treated to 40-45 Gy in 20-25 fractions. During radiotherapy, concurrent oral capecitabine will be administered at a dose of 1,600 mg\u002Fm² on Days 1-14, every 21 days for 2 cycles. Following the completion of radiotherapy, maintenance oral capecitabine will be continued at 2,000 mg\u002Fm² on Days 1-14, every 21 days for 6 cycles. For patients intolerant to capecitabine, S-1 will be substituted: concurrent S-1 40-50 mg twice daily on Days 1-28, every 42 days for 1 cycle, followed by maintenance S-1 40-60 mg twice daily on Days 1-28, every 42 days for 3 cycles.\n\nThe primary study endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary study endpoints include the 2-year overall survival (OS) rate, locoregional control rate, and incidence of grade ≥3 adverse events.\n\nA total of 92 patients are planned for enrollment in this trial.",[26],"Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma","RECRUITING","2026-06-21",{"date":30,"type":31},"2026-06-24","ACTUAL",{"date":33,"type":31},"2026-06-16",{"date":35,"type":20},"2029-05-30",{"name":37,"class":38},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER"]