Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated December 30, 2022 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-02-02.
Trial Details
NCT Number NCT05236972
Lead Sponsor Sun Yat-sen University
Collaborators: Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital
Conditions Colorectal Carcinoma
Enrollment 323 participants
Start Date 2022-01-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2022-12-30