Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resec… (NCT07412613) | Clinical Trial Compass
RecruitingPhase 3
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
China386 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.
✓. Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) .
✓. Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17S250, or combinations of other guidelines and clinically recognized site) , or mismatch repair detection demostrates dMMR (evaluating the expression of 4 MMR proteins: MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and positive expression is localized to the nucleus).
✓. Before enrollment, the participant needs to be evaluated by the responsible surgeon to confirm whether he/she is eligible for radical R0 resection, and does not require combined organ resection based on medical history.
Exclusion criteria
✕. 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.).
What they're measuring
1
Pathologic Complete Response (pCR) rate as assessed by investigator
✕. 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.
✕. Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.
✕. Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation.
✕. Previous history of pneumonitis/interstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis.
✕. Experiencing severe infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; having received systemic anti-infection treatment for active infection within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or hepatitis C).