RecruitingNCT07352280

Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal Cancer

An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

30 participants

Start Date

Feb 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR/MSI-H) locally advanced colorectal cancer. All patients will receive three cycles of tislelizumab neoadjuvant therapy followed by curative surgery. Postoperatively, based on surgical pathology, patients will receive adjuvant therapy with a regimen selected by the investigator or adopt a watch-and-wait strategy. The investigators will conduct a 5-year prospective follow-up. The investigators plan to enroll approximately 30 subjects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tislelizumab, an immunotherapy drug, given before surgery for stage II or III colorectal cancer that has a specific genetic feature called dMMR or MSI-H. This type of colorectal cancer responds unusually well to immunotherapy, and researchers want to see if giving it before surgery can shrink or even eliminate the tumor. **You may be eligible if:** - You are 18 or older with good general health (ECOG performance status 0–2) - You have been diagnosed with stage II or III colorectal cancer confirmed by biopsy - Your tumor has been tested and found to be dMMR or MSI-H (a specific genetic marker) - You have signed an informed consent form **You may NOT be eligible if:** - You have other serious medical conditions that make surgery unsafe - You have active autoimmune disease, inflammatory bowel disease, chronic infections, or a history of organ transplant - You are on long-term immune-suppressing medications - You have had a severe allergic reaction to tislelizumab or similar drugs (PD-1/PD-L1 inhibitors) - You have severe lung scarring (pulmonary fibrosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Undefined, China

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NCT07352280


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