Cholangiocarcinoma Clinical Trial
Official title:
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University.
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.
n/a
| NCT number | NCT05207735 |
| Study type | Interventional |
| Source | Henan Cancer Hospital |
| Contact | Jinxue Zhou, MD |
| Phone | 13837175001 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Start date | January 2022 |
| Completion date | December 2024 |
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