NCT05841134

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MSI-H Colorectal Cancer
• Tislelizumab
• Oxaliplatin
• Capecitabine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-12-31
• Completion: 2027-01-31
• First posted: 2023-05-03
• Last updated: 2023-05-09