Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
MSI-H Colorectal Cancer, Tislelizumab, Oxaliplatin
About this trial
This is an interventional treatment trial for MSI-H Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: ECOG: 0~1; Patients with colon or rectal adenocarcinoma confirmed by histology or cytology; 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); 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); Expected survival period ≥ 12 weeks; The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits. Exclusion Criteria: Have received anti-tumor therapy; Have received PD-(L)1 or CTLA-4 treatment; 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); 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; Patients with any severe and/or uncontrolled diseases Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity > 1.0g; Pregnant or lactating women; Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); Those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;
Sites / Locations
Arms of the Study
Arm 1
Experimental
Tislelizumab combined with CAPOX
Successfully screened subjects will receive 4 cycles of neoadjuvant therapy with tislelizumab combined with chemotherapy (CAPOX) before surgery; undergo radical surgery 4-6 weeks after the end of the last medication; tislelizumab will be given after surgery Monoclonal antibody ± chemotherapy adjuvant therapy (the investigator judges whether to add chemotherapy based on the patient's comprehensive condition), until disease progression or unacceptable toxicity, the longest treatment is 12 months.