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

February 18, 2026 updated by: LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Undefined
      • Beijing, Undefined, China
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal adenocarcinoma registered and treated at the Cancer Hospital Chinese Academy of Medical Sciences.

Description

Inclusion Criteria:

  1. Age ≥ 18 years, ECOG performance status score 0-2.
  2. Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition).
  3. Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor.
  4. Signed written informed consent.

Exclusion Criteria:

  1. The patient has a history of other serious conditions rendering them unsuitable for surgery.
  2. Subjects with the following conditions: active autoimmune diseases, active infectious diseases, inflammatory bowel diseases; requiring long-term glucocorticoid or immunosuppressive therapy during treatment; history of immunodeficiency; history of organ transplantation or haematopoietic stem cell transplantation; severe interstitial pneumonia or pulmonary fibrosis.
  3. Known hypersensitivity to any component or excipient of tislelizumab or other PD-1/PD-L1 agents.
  4. Other conditions deemed unsuitable for inclusion by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
dMMR/MSI-H CRC
Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response
Time Frame: Up to 3 weeks after surgery
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab.
Up to 3 weeks after surgery
Treatment emergent adverse events
Time Frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.
Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 5 years
Up to 5 years
Clinical complete response
Time Frame: Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival
Time Frame: Up to 2 years
Up to 2 years
Treatment related adverse events
Time Frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Immunotherapy related adverse events
Time Frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC5791

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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