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

StatusRecruiting
PhasePhase 3
SponsorAkeso
Started2026-04-15
View on ClinicalTrials.gov ↗

Amendment history

2026-04-20
Study Status, Study Description, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-03-15→confirmed 2026-04-15
Study sitesdetails revised at 1 of 1 site
2026-02-25
Study Status, Outcome Measures, Contacts/Locations v1
Secondary endpoints5 entries, revised
SafetyAdverse assessmentevent
2026-02-09
Original filing
Akeso
96 trials monitored
See 1 trial at risk
Colorectal Cancer
2,904 trials monitored
See 127 trials at risk
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.
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