Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma

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.

NCT Number	NCT07468630
Lead Sponsor	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Collaborators: Southwest Hospital, China, Chongqing Shapingba District People's Hospital
Conditions	Colon Adenocarcinoma
Enrollment	106 participants
Start Date	2026-04-10
Primary Completion	2026-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-12