Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
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.
Eligibility criteria
Qualifiers
Voluntarily sign a written ICF.
≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.
Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.
Life expectancy greater than 2 years.
Disqualifiers
Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).
Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.
History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.
Trial design
Treatments tested in this trial
- Cadonilimab (AK104)
- Oxaliplatin
- Capecitabine
- 5- Fluorouracil
- Calcium Folinate
Treatment groups
386 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov