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Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05207735
Study type Interventional
Source Henan Cancer Hospital
Contact Jinxue Zhou, MD
Phone 13837175001
Status Not yet recruiting
Phase Phase 2
Start date January 2022
Completion date December 2024

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