Overview

PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma.

Status:
Not yet recruiting

Trial end date:
2024-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Henan Cancer Hospital

Treatments:

Capecitabine