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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years, ECOG performance status score 0-2. 2. Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition). 3. diagnosed by tissue sample (biopsy-confirmed) mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor. 4. Signed written willing to sign a consent form. Who Should NOT Join This Trial: 1. The patient has a history of other serious conditions rendering them unsuitable for surgery. 2. Subjects with the following conditions: active autoimmune conditions (where your immune system attacks your own body)s, active infectious diseases, inflammatory bowel diseases; requiring long-term glucocorticoid or immunosuppressive therapy during treatment; history of weakened immune system; 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Undefined, China