NCT05160727

Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Recurrence and Metastatic Colorectal Cancer

A Multicenter Phase II Clinical Study of Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Inoperable Recurrence and Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Explore the efficacy of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer patients; To evaluate the safety and tolerability of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer; To evaluate the radiosensitization effects of Tslelizumab and irinotecan;

Conditions

• Mismatch Repair-proficient
• Colorectal Cancer Metastatic
• Microsatellite Stable

Interventions

Type	Name	Description
DRUG	Tislelizumab	200mg ivgtt d1 q3w
DRUG	Irinotecan	Concurrent Chemoradiotherapy: Irinotecan: 80mg/m2/w (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2/w (UGT1A1\*28 and \*6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1\*28 and \*6: 7/7+GG or 6/6+AA or 6/7+GA) Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w.
RADIATION	radiotherapy	radiotherapy

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2021-12-16
• Last updated: 2021-12-20

Locations

1 site across 1 country: China