Actively Recruiting
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Led by Akeso · Updated on 2026-04-22
386
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form
- Age between 18 and 75 years at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 2 years
- Histologically confirmed primary colon adenocarcinoma located 12 cm or more from the anal verge
- Resectable stage IIB-III colon cancer based on imaging (enhanced CT or MRI)
- Confirmed microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) status
- Eligible for radical R0 surgical resection without need for combined organ removal
- Female participants of childbearing potential must have a negative pregnancy test before first dose and agree to use contraception during the study and for 120 days after last dose
- Male participants who are not sterilized must agree to use effective contraception during the study and for 120 days after last dose
You will not qualify if you...
- Prior anti-tumor treatment for current colon cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Other malignant tumors within the past 3 years or currently active, except certain cured local tumors
- Participation in investigational drug or device treatment within 4 weeks before randomization
- History of immunodeficiency, positive HIV test, or long-term use of immunosuppressive drugs
- Active tuberculosis or syphilis infection
- History of organ or stem cell transplantation
- Prior pneumonitis or interstitial lung disease requiring corticosteroids
- Severe infection within 4 weeks before randomization or recent systemic anti-infection treatment
- Active hepatitis B infection not controlled by antiviral therapy
- Pregnant or breastfeeding women
- Any other disease, treatment, or abnormal lab results that may interfere with study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
X
Xufang Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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