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

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About this study

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.

Condition
Colo-rectal Cancer (dMMR/MSI-H CRC)
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Colo-rectal Cancer (dMMR/MSI-H CRC)
  • 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.

Exclusion 4

  • 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.
  • Other conditions deemed unsuitable for inclusion by the investigator.

Where

1 site, 1 recruiting

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Undefined, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.