drugset / Trial / NCT05236972
PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer
Phase 3
Recruiting
323 enrolled
Sun Yat-sen University
Second Affiliated Hospital, School of Medicine, Zhejiang University · collabWest China Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In this open-label phase III study, patients with local advanced colon cancer (TanyN+ ,M0, dMMR/MSI-H, at least 10cm from the anus verge)will be scheduled to Group A: receive anti-PD-1 antibody alone (8 cycles, 200mg iv drip Q3W) and Group B (4 or 8 cycles of XELOX: oxaliplatin 130mg/m2 day 1, capecitabine 2000mg/m2 days 1-14, repeated every 21 days). The primary endpoint was 3 Disease-free survival; analyses were done based on all patients with post-randomization data.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2026-06-01
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |