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RECRUITING
NCT05236972
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

323

Start Date

2022-01-01

Completion Date

2028-12-31

Last Updated

2022-12-30

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun Yat-sen University

Guangzhou, China