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NOT YET RECRUITING
NCT07412613
PHASE3

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

Sponsor: Akeso

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

386

Start Date

2026-03-15

Completion Date

2031-03-15

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, China