A Phase 2 interventional study of Tislelizumab in MSI-H Colorectal Cancer, Tislelizumab and Oxaliplatin, sponsored by The First Affiliated Hospital of Zhengzhou University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 25 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Tislelizumab
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.
Also known as: Capecitabine, Oxaliplatin
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Zhengzhou University