drugset / Trial / NCT07840677
Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer
Phase 2
Recruiting
70 enrolled
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
940 Hospital of the People's Liberation Army Joint Logistic Support Force · collabChongqing Yongchuan District People's Hospital, Deyang People's Hospital · collabGuang'an People's Hospital, Kaizhou District People's Hospital · collabJiangbei Campus of The First Affiliated Hospital of Army Medical University (Army 958 Hospital) · collabShapingba District People's Hospital · collabThe Second Affiliated Hospital of Chongqing Medical University · collabThird Affiliated Hospital of Chongqing Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This multicenter, randomized, open-label, blinded-endpoint Phase II trial assesses the efficacy and safety of tolecizumab (PCSK9 inhibitor) plus sintilimab/CapeOX chemoimmunotherapy as neoadjuvant treatment for pMMR/MSS locally advanced colon adenocarcinoma .
Timeline
- Start
- 2026-09-20
- Primary completion
- 2029-09-20
- Completion
- 2029-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tafolecimab | Monoclonal antibody | 600 mg | Subcutaneous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |