OncoMatch/Clinical Trials/NCT07840677
Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer
Official title: A Multicenter, Randomized, Two-arm, Open-label, Blinded Endpoint, Phase II Study of PCSK9 Inhibitor Tafolecimab Combined With Sintilimab and CapeOX Chemotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer (TRIUNITE-08)
Is NCT07840677 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Tafolecimab and Sintilimab for colon cancer.
Treatment: Tafolecimab · 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 .
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: Mismatch-repair proficient (pMMR / MSS)
Disease stage
Required: Stage CT3C OR ABOVE
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
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
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)
Sufficient bone marrow, liver, kidney and coagulation functions 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 NCT07840677 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.
Does this trial require MLH1?
Yes, MLH1 wild-type is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 wild-type is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 wild-type is a required biomarker for enrollment.
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