Actively Recruiting
Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2026-03-12
106
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
D
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead Sponsor
S
Southwest Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to participate voluntarily
- Confirmed colon adenocarcinoma at cT3c stage or above
- Age between 18 and 80 years, any gender
- Tumor lower edge more than 10 cm from the anus
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver, kidney, and coagulation function by lab tests
- No prior anti-tumor treatment for current colon cancer
- No pregnancy or lactation in female patients
- Male patients agree to use effective contraception during the study
You will not qualify if you...
- Previous anti-tumor treatment for current colon cancer
- Prior use of PCSK9 inhibitors or PD-1/PD-L1 inhibitors
- Active or history of autoimmune diseases
- Receiving immunosuppressants or systemic glucocorticoids (except low-dose local use)
- Active infection requiring systemic anti-infective treatment
- Severe cardiovascular diseases such as severe hypertension, myocardial infarction, heart failure
- Complicated primary tumor including perforation or unresolved intestinal obstruction
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by investigator such as poor compliance or severe organ dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting
Chongqing, Chongqing Municipality, China
Actively Recruiting
Research Team
F
fan Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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