Spots Global Cancer Trial Database for PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.
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Trial Identification
Brief Title: PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.
Official Title: Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University.
Study ID: NCT05207735
Conditions
Interventions
Study Description
Brief Summary: This is a single-center, single-arm, prospective phase II clinical study to evaluate the effectiveness and safety of Sintilimab combined with capecitabine in patients after radical resection of cholangiocarcinoma. The primary endpoint of the study: • 2-year recurrence-free survival rate Secondary endpoint: • Overall survival (OS), 1y RFS%, 2y OS%, 3y OS%, time to recurrence (TTR), RFS;Safety and tolerability. Study drugs, dosages, and methods of administration: * Sintilizumab, 200 mg, intravenous infusion, a treatment cycle every 3 weeks, administration on the first day of each cycle, 6 cycles. * Capecitabine: 1250 mg/m2, orally, twice a day, 1-14 days, one treatment cycle every three weeks, 8 cycles.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Jinxue Zhou, MD
Affiliation: Henan cancer hospital,affiliated cancer hospital of zhengzhou university
Role: STUDY_CHAIR
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