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

NCT07352280 | Recruiting

• 1 other identifier: NCC5791
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colo-rectal Cancer (dMMR/MSI-H CRC)

Keywords

tislelizumab; dMMR/MSI-H stage II-III colorectal cancer; neoadjuvant therapy

Outcome Measures

Primary Outcomes (2)

• Pathological complete response

  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

  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 Outcomes (5)

• Clinical complete response

  Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment

• Event free survival

  Up to 2 years

• Overall survival

  Up to 5 years

• Treatment related adverse events

  Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

• Immunotherapy related adverse events

  Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Study Arms (1)

dMMR/MSI-H CRC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• The patient has a history of other serious conditions rendering them unsuitable for surgery.
• 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.
• Known hypersensitivity to any component or excipient of tislelizumab or other PD-1/PD-L1 agents.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Undefined, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tumours

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Lin Yang

CONTACT

8601087788145; linyangcicams@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

CN (1)