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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Neoadjuvant treatment options: Tislelizumab 200mg, intravenous infusion, D1, Q3W, a total of 4 cycles; Oxaliplatin 130mg/m2, intravenous infusion, D1, Q3W, 4 cycles in total; Capecitabine 1000mg/m2, orally twice in the morning and evening, D1-14, Q3W, 4 cycles in total; Adjuvant treatment options: Tislelizumab 200mg, intravenous infusion, Q3W; ± Chemotherapy method (researcher judges whether to add chemotherapy according to the comprehensive condition of the patient); Until disease progression or unacceptable toxicity, the maximum treatment time is 12 months.
Percentage of Participants With Pathological Complete Response (pCR)
After receiving tislelizumab combined with CAPOX neoadjuvant, the rate of pathological complete remission (after neoadjuvant therapy, for those who insist on organ preservation, combined with imaging and endoscopic examination to achieve cCR, and the biopsy result of the microscope is pathological Complete remission can be judged as pCR)
Time frame: Up to 24 months
R0 resection rates
The proportion of patients achieved a complete resection with negative margin.
Time frame: Up to 24 months
Overall survival (OS)
Defined as the time from randomization to death from any cause.
Time frame: Up to 36 months
Event-free survival (EFS)
Event-free survival is the time from the beginning of enrollment to the occurrence of any event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, and occurrence of fatal or intolerable side effects
Time frame: Up to 36 months
Incidence of adverse events during the treatment and follow-up (safety)
Adverse events will be assessed during treatment and follow-up.
Time frame: until 100 days after last patient last study drug treatment
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