drugset / Trial / NCT07412613
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-04-15
- Primary completion
- 2030-06-15
- Completion
- 2031-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cadonilimab | Monoclonal antibody | — | — |
| Comparator | Capecitabine | Small molecule | — | Oral |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Comparator | fluorouracil | Small molecule | — | Intravenous |