Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Undefined, China
Actively Recruiting
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
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