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

Recruiting Phase 3 Interventional Study
Resectable Colon Cancer MSI-H/dMMR Colorectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
386 (estimated)
Sponsor
Akeso · Industry
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign a written ICF. 2. ≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex. 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. 4. Life expectancy greater than 2 years. 5. Histologically confirmed primary colon ade…
Contacts

Xufang Yu, MD

021-60472800

xufang.yu@akesobio.com

CONTACT