Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma

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.

Trial Details

NCT ID
NCT07468630
Phase
PHASE2
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Tolecizumab (PCSK9 Inhibitor)
  • Sintilimab
Locations (sample)
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771

Key Eligibility Criteria

  • Signed the written informed consent form and voluntarily participate in the study.
  • Pathohistologically confirmed colon adenocarcinoma with cT3c stage or above. Aged 18 to 80 years, regardless of gender. The lower edge of the tumor…
  • No previous anti-tumor treatment for the current colon cancer (including radiotherapy, chemotherapy, surgery, etc.).
  • No pregnancy or lactation for female patients; male patients agree to take effective contraceptive measures during the study.

For full eligibility, visit ClinicalTrials.gov.

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