Actively Recruiting

Age: 18Years +
All Genders
NCT07352280

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-02-19

30

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with ECOG performance status 0-2
  • Pathologically confirmed stage II-III colorectal adenocarcinoma according to AJCC 8th edition
  • Histologically confirmed mismatch repair deficient or genetic testing confirmed high microsatellite instability tumor
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • History of serious conditions that make surgery unsuitable
  • Active autoimmune diseases, active infectious diseases, or inflammatory bowel diseases
  • Requirement for long-term glucocorticoid or immunosuppressive therapy during treatment
  • History of immunodeficiency
  • History of organ or hematopoietic stem cell transplantation
  • Severe interstitial pneumonia or pulmonary fibrosis
  • Known allergy to tislelizumab or other PD-1/PD-L1 agents
  • Other conditions considered unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Undefined, China

Actively Recruiting

Loading map...

Research Team

L

Lin Yang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here