[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642039":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":11,"studyPopulation":11,"armGroups":27,"interventions":34,"overallOfficials":11,"centralContacts":45,"locations":51,"responsibleParty":65,"collaborators":11,"id":69,"slug":11,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":11,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"2-year recurrence-free survival (RFS) rate",null,"From completion of radiotherapy until 2 years after radiotherapy",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"2-year overall survival (OS) rate",{"measure":17,"description":11,"timeFrame":12},"Locoregional control rate",{"measure":19,"description":11,"timeFrame":20},"Incidence of grade ≥3 treatment-related adverse events","From initiation of radiotherapy until 3 months after radiotherapy",{"allocation":22,"interventionModel":23,"interventionModelDescription":11,"primaryPurpose":24,"observationalModel":11,"timePerspective":11,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":11,"whoMasked":11},"NONE",[28],{"label":29,"type":30,"description":11,"interventionNames":31},"Postoperative Concurrent Chemoradiotherapy Group","EXPERIMENTAL",[32,33],"Radiation: Postoperative radiotherapy","Drug: Capecitabine or S-1",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"RADIATION","Postoperative radiotherapy","All patients will receive postoperative concurrent chemoradiotherapy with IMRT or 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.",[29],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"DRUG","Capecitabine or S-1","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.",[29],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Bo Chen, MD","CONTACT","00861324000876","chenboo@outlook.com",[52],{"facility":5,"status":53,"city":54,"state":11,"zip":11,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Beijing","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},[64],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","BO CHEN","Associate Professor","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":78,"type":79},92,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma","2026-06-21",{"date":88,"type":89},"2026-06-24","ACTUAL",{"date":91,"type":89},"2026-06-16",{"date":93,"type":79},"2029-05-30",{"name":5,"class":6},1]