Adding tolecizumab to chemoimmunotherapy before surgery for locally advanced pMMR/MSS colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label, blinded-endpoint Phase II trial that randomizes 106 patients 1:1 to receive either tolecizumab plus sintilimab with CapeOX or sintilimab with CapeOX alone as four cycles of neoadjuvant therapy. The primary endpoint is the pathological complete response (pCR) rate after neoadjuvant treatment, with secondary endpoints including MPR, ORR, R0 resection rate, PFS, OS, and adverse events by NCI-CTCAE v5.0. Safety follow-up continues for 90 days after last dosing and survival follow-up every 3 months for 3 years, and biological samples will be collected for exploratory biomarker analyses. A DSMB will monitor the study and all study drugs and related exams are provided free to participants.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Daping Hospital Third Military Medical University, chongqing, chongqing 400000 Recruiting
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: fan Li, PhD
• Email: levinecq@163.com
• Phone: 86-18696539200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.