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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07352280

Enrollment

Registered

2026-01-20

Start date

2026-02-01

Completion date

2032-12-31

Last updated

2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Treatment emergent adverse events	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.
Pathological complete response	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.

Secondary

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

Countries

China

Contacts

CONTACTLin Yang

linyangcicams@126.com8601087788145

Outcome results