OncoMatch/Clinical Trials/NCT07468630
Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
Is NCT07468630 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Tolecizumab (PCSK9 Inhibitor) and Sintilimab for colon adenocarcinoma.
Treatment: Tolecizumab (PCSK9 Inhibitor) · Sintilimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage CT3C OR ABOVE (TNM)
cT3c stage or above
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-tumor treatment
No previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.)
Cannot have received: PCSK9 inhibitor
Previous use of PCSK9 inhibitors
Cannot have received: anti-PD-1 therapy
Previous use of PD-1/PD-L1 inhibitors
Cannot have received: anti-PD-L1 therapy
Previous use of PD-1/PD-L1 inhibitors
Lab requirements
Blood counts
sufficient bone marrow function assessed by laboratory tests (in accordance with the local laboratory reference range)
Kidney function
sufficient kidney function assessed by laboratory tests (in accordance with the local laboratory reference range)
Liver function
sufficient liver function assessed by laboratory tests (in accordance with the local laboratory reference range)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07468630 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CT3C OR ABOVE is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages