Clinical Trial

Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

Recruiting Phase 3
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Summary
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-23
Trial Details
NCT Number NCT07412613
Lead Sponsor Akeso
Conditions Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer
Enrollment 386 participants
Start Date 2026-04-15
Primary Completion 2030-06-15 (estimated)
Study Completion 2031-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-22