[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640897":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":32,"responsibleParty":34,"collaborators":32,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":32,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":60,"whyStopped":32,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":32},{"fullName":5,"class":6},"Sir Run Run Shaw Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GC Chemotherapy Plus Envafolimab Arm","EXPERIMENTAL","Participants first receive GC chemotherapy plus envafolimab every 3 weeks (Q3W) for a total of 3 cycles (each cycle is 21 days). Eligibility for surgery is then assessed; eligible patients undergo radical resection.",[13],"Drug: Neoadjuvant therapy followed by surgery",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Neoadjuvant therapy followed by surgery","First:\n\nEnvafolimab: 400 mg on Day 1, repeated every 3 weeks (Q3W). GC chemotherapy: Gemcitabine: 1000 mg\u002Fm2 in 100 mL of 0.9% sodium chloride injection, administered intravenously over 30 minutes on Days 1 and 8, repeated Q3W. Cisplatin: 25 mg\u002Fm2 in 500 mL of 5% glucose injection, administered intravenously over 2 hours on Day 1 and 8, repeated Q3W.\n\nOf note, no target drugs is involved.\n\nSecond:\n\nRadical resection eligibility will be assessed by the investigator; those with indeterminate resectability require additional MDT discussion confirmation. The criteria for radical resection:\n\n1. No invasion of the main trunk of the hepatic vein, portal vein, or inferior vena cava;\n2. No distant metastasis except for hilar lymph node metastases;\n3. Minimum distance between surgical margin and tumor border ≥ 0.5 cm;\n4. Residual liver volume ≥ 30% (≥ 40% for participants with cirrhosis).",[9],[21],"Envafolimab, Gemcitabine, Cisplatin; Neoadjuvant GC-Envafolimab for Resectable Biliary Tract Malignancies",[23],{"name":24,"affiliation":25,"role":26},"Yuelong Liang, Ph.D","Sir Run Run Shaw Hospital, Schoole of Medicine, Zhejiang University","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Yifan Tong, Ph.D","CONTACT","86 571 86006271",null,"tongyf@zju.edu.cn",{"type":26,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Yifan Tong, PhD","Director, Head of General Surgery of Dayunhe Campus, Principal Investigator, Clinical Professor","100640897","phase-2-gemcitabine-cisplatin-plus-envafolimab-in-resectable-biliary-tract-malignancies-100640897",false,"NCT07599995","Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies","The Efficacy and Safety of Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy in Resectable Biliary Tract Malignancies at High Risk of Recurrence","GENE","Inclusion Criteria:\n\n* Participants who have signed a written Informed Consent Form (ICF);\n* Male or female participants aged 18-80 years;\n* Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0\u002F1;\n* Biliary Tract Cancer (BTC) diagnosed by puncture pathology prior to enrollment;\n* Participants must meet the following requirements for major vital organ function: a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count ≥ 90×10⁹\u002FL; hemoglobin ≥ 9 g\u002FdL; b. Coagulation function: international normalized ratio (INR) ≤ 1.2; c. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); d. Serum albumin ≥ 3.5 g\u002FdL; total bilirubin ≤ 1.5 times the ULN. Patients with obstructive jaundice who meet the eligibility criteria after percutaneous transhepatic cholangial drainage or endoscopic retrograde cholangiopancreatography treatment are also eligible for enrollment; e. Child-Pugh class A or B; f. Serum creatinine ≤ 1.5 times the ULN;\n* Patients with high-risk factors for recurrence. The criteria are defined as meeting at least one of the following: a. Preoperative CA19-9 ≥ 200 U\u002FmL; b. Tumor diameter ≥ 5 cm or multiple tumor nodules on imaging; c. Regional lymph node metastasis with a short-axis diameter ≥ 1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; e. Low or undifferentiated histologic grade;\n* Participants who have at least 1 measurable lesion (RECIST v1.1);\n* Be able to provide fresh stool samples and liver samples if undergoing surgery.\n\nExclusion Criteria\n\n* Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocarcinoma malignant tumor components;\n* Prior systemic therapy for BTC, including immunotherapy, targeted therapy, or chemotherapy;\n* History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years;\n* Presence of an active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to ≥ 10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids will not be excluded;\n* Presence of ascites, hepatic encephalopathy, sclerosing cholangitis, or other concurrent organ dysfunctions that would preclude tolerance of general anesthesia or hepatectomy;\n* Women who are breastfeeding or pregnant;\n* Any other factors that, in the investigator's judgment, may compromise participant safety or trial compliance, including serious comorbidities requiring ongoing treatment, clinically significant laboratory abnormalities, or relevant social or family-related issues.","ALL","18 Years","80 Years",{"count":49,"type":50},34,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.",[56],"Biliary Tract Cancer",[58,59],"Resectable Biliary Tract Cancer","High Risk of Recurrence","NOT_YET_RECRUITING","2026-05-17",{"date":63,"type":64},"2026-05-20","ACTUAL",{"date":66,"type":50},"2026-05-30",{"date":68,"type":50},"2030-03-30",{"name":5,"class":6}]