NCT07412613

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

A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 conlon cancer.

Conditions

• Resectable Colon Cancer
• MSI-H/dMMR Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cadonilimab (AK104)	Anti-PD-1/CTLA-4 tetrameric bispecific antibody
DRUG	Oxaliplatin	Intravenous
DRUG	Capecitabine	Oral
DRUG	5- Fluorouracil	Intravenous
DRUG	Calcium Folinate	Intravenous

Timeline

• Start date: 2026-03-15
• Primary completion: 2030-06-15
• Completion: 2031-03-15
• First posted: 2026-02-17
• Last updated: 2026-02-27

Locations

1 site across 1 country: China