Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Apr 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with stage II or III colorectal cancer that has specific genetic characteristics known as MSI-H or dMMR. The treatment involves a combination of a medication called tislelizumab and a chemotherapy regimen known as CAPOX, which includes two drugs: oxaliplatin and capecitabine. The goal is to see how well this treatment works and to ensure it is safe for patients. The trial is not yet open for recruitment, but it will focus on gathering information from multiple medical centers.

To be eligible for this trial, participants should be adults aged between 18 and 75 who have been diagnosed with colon or rectal cancer confirmed by a medical test. They must also have specific test results showing their cancer has MSI-H characteristics. Additionally, participants should be in good overall health with an expected survival of at least 12 weeks and be willing to commit to follow-up visits. However, certain individuals, such as those who have recently received other cancer treatments or have active autoimmune diseases, will not be eligible. Participants can expect regular monitoring and care throughout the study, contributing to important research that could improve treatment options for colorectal cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ECOG: 0\~1;
• • 2. Patients with colon or rectal adenocarcinoma confirmed by histology or cytology;
• • 3. The tissue specimens are confirmed as MSI-H by PCR or NGS. If the patients are dMMR by immunohistochemistry, they need to be confirmed as MSI-H by PCR (2021 Expert Consensus on Immunotherapy for Patients with Colorectal Cancer);
• • 4. Patients with clinical stage II or III (cT3-T4 N0 M0 or Tany N+M0, clinically positive lymph nodes are defined as any lymph node ≥ 1.0 cm);
• • 5. Expected survival period ≥ 12 weeks;
• • 6. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.
• Exclusion Criteria:
• • 1. Have received anti-tumor therapy;
• • 2. Have received PD-(L)1 or CTLA-4 treatment;
• • 3. The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included);
• • 4. Patients are using immunosuppressants or systemic hormone therapy to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other equivalent hormones), and continue to use within 2 weeks before enrollment;
• • 5. Patients with any severe and/or uncontrolled diseases
• • 6. Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity \> 1.0g;
• • 7. Pregnant or lactating women;
• • 8. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• • 9. Those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;