drugset / Trial / NCT07468630
Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
Phase 2
Recruiting
106 enrolled
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing Shapingba District People's Hospital · collabSouthwest Hospital, China · 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 (cT3c+). 106 patients are 1:1 randomized to the combination or chemoimmunotherapy alone, with pCR as the primary endpoint.
Timeline
- Start
- 2026-04-10
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolecizumab | Unknown | 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 |