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

Recruitingn/aAges 18 Years - anyAllCancer Institute and Hospital, Chinese Academy of…
NCT07352280 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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