CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 386 target
Drug / intervention
Cadonilimab (AK104) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07412613
NCT07412613Phase 3RecruitingOn TrackUpdated 2mo ago
CompareCT.gov

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

Akeso·interventional·Posted Feb 17, 2026·Updated Apr 22, 2026

In Brief

A Phase 3 clinical trial evaluating Cadonilimab (AK104), Oxaliplatin, and 3 other interventions for Resectable Colon Cancer and MSI-H/dMMR Colorectal Cancer. Currently recruiting, targeting 386 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResectable Colon Cancer, MSI-H/dMMR Colorectal Cancer
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
202620272028202920302031
First PostedFeb 17, 2026
Enrollment StartApr 15, 2026
Primary CompletionJun 15, 2030
Study CompletionMar 15, 2031
TodayJul 1, 2026
Enrollment to primary: 4.2 yearsPosted 4 months agoPrimary completion in 4.0 years

Interventions

Cadonilimab (AK104)drug

Anti-PD-1/CTLA-4 tetrameric bispecific antibody

Oxaliplatindrug

Intravenous

Capecitabinedrug

Oral

5- Fluorouracildrug

Intravenous

Calcium Folinatedrug

Intravenous