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RECRUITING
NCT07468630
PHASE2

Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma

Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Open-Label, Blinded-Endpoint Phase II Study of Tolecizumab (a PCSK9 Inhibitor) Enhancing Chemoimmunotherapy as Neoadjuvant Treatment for Patients With pMMR/MSS Locally Advanced Colon Adenocarcinoma (TRIUNITE-08)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2026-04-10

Completion Date

2028-12-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Tolecizumab (PCSK9 Inhibitor)

Tolecizumab (PCSK9 Inhibitor) 600mg, subcutaneous injection, Q6W (Weeks 1,7), 2 doses total Sintilimab (PD-1 Inhibitor) 200mg, intravenous infusion, Q3W (Weeks1,4,7,10), 4 cycles total CapeOX Regimen (Oxaliplatin + Capecitabine) Oxaliplatin 130mg/m² IV Q3W (4 cycles); Capecitabine 1000mg/m² oral twice daily, Days1-14 per cycle

DRUG

Sintilimab

1. Oxaliplatin: 130mg/m² intravenous infusion, Q3W at Week 1,4,7,10, total 4 cycles; 2. Capecitabine: 1000mg/m² oral administration, twice daily, Days 1-14 of each chemotherapy cycle. All drugs free of charge. 2. Sintilimab 200mg intravenous infusion, administered every 3 weeks (Q3W) at Week 1, 4, 7, 10, total 4 cycles; provided free of charge by the sponsor, used for neoadjuvant immunotherapy.

Locations (1)

Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting

Chongqing, Chongqing Municipality, China