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โ† Trials
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Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma

RecruitingPhase 2Ages 18 Years - 80 YearsAllDaping Hospital and the Research Institute of Surโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 is more than 10 cm from the anus. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Sufficient bone marrow, liver, kidney and coagulation functions assessed by laboratory tests (in accordance with the local laboratory reference range). 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. Exclusion Criteria: * Previous anti-tumor treatment for the current colon cancer. Previous use of PCSK9 inhibitors or PD-1/PD-L1 inhibitors. Active autoimmune diseases or a history of autoimmune diseases. Receiving immunosuppressant or systemic glucocorticoid therapy (except for local low-dose glucocorticoid use). Active infection requiring systemic anti-infective treatment. Severe cardiovascular diseases (e.g., severe hypertension, myocardial infarction, heart failure, etc.). Complicated primary tumor (e.g., tumor perforation, intestinal obstruction without relief after intervention). Pregnant or lactating women. Other conditions that the investigator deems unfit for participation in the study (e.g., poor compliance, severe organ dysfunction, etc.).
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What it tests

  • Tolecizumab (PCSK9 Inhibitor)
  • Sintilimab
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Where

1 site
Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting
Chongqing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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