NCT05207735

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

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	* 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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-01-26
• Last updated: 2022-01-26