NCT05236972

PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer

Study of Sintilimab vs Standard Therapy in Participants With Mismatch Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Stage III Colorectal Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg iv drip Q3W
DRUG	Oxaliplatin	130 mg/m² iv drip over 2 hours on day 1, repeated every 21 days.
DRUG	capecitabine	1000 mg/m² po twice daily on days 1- 14 repeated every 21 days

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-06-01
• Completion: 2028-12-31
• First posted: 2022-02-11
• Last updated: 2022-12-30

Locations

1 site across 1 country: China