Multicenter, Single-arm, Open-label Phase II Clinical Study of Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2027-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-center, single-arm, open-label phase II clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (CAPOX) in stage II or III colorectal cancer with MSI-H/dMMR Patient efficacy and safety.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Treatments: Capecitabine; Oxaliplatin

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;