RecruitingPhase 2NCT07468630

Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma

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)


Sponsor

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

Enrollment

106 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two immunotherapy drugs — tolecizumab (a PCSK9 inhibitor) and a PD-1/PD-L1 checkpoint inhibitor — to standard chemotherapy before surgery improves outcomes for patients with locally advanced colon cancer that has not yet been treated. **You may be eligible if...** - You have been confirmed by biopsy to have colon adenocarcinoma at a locally advanced stage (cT3c or higher) - You are between 18 and 80 years old - Your tumor is more than 10 cm from the anal opening (i.e., it is in the colon, not the rectum) - You have good overall physical function (ECOG 0 or 1) - You have not received any prior treatment for this cancer - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have had any prior treatment for this colon cancer - You have previously used PCSK9 inhibitors or PD-1/PD-L1 immunotherapy drugs - You have an active autoimmune disease or are taking immunosuppressants - You have a serious active infection requiring antibiotics - You have severe heart disease or other major health conditions - You have a complicated tumor (such as a perforation or bowel blockage) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTolecizumab (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

DRUGSintilimab

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

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NCT07468630


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