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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age ≥ 18 years, ECOG performance status score 0-2.

• Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition).

• Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor.

• Signed written informed consent.

Locations
Other Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Lin Yang
linyangcicams@126.com
8601087788145
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 30
Treatments
dMMR/MSI-H CRC
Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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