Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-11; most recent amendment 2026-02-18.
Status change: Not Yet Recruiting → Recruiting 2026-02-18
Trial Details
NCT Number NCT07352280
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Colo-rectal Cancer (dMMR/MSI-H CRC)
Enrollment 30 participants
Start Date 2026-02-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-19