NCT05143099

Phase II Study of Tislelizumab Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory mCRC

Phase II Clinical Study on the Efficacy and Safety of Immune Checkpoint Inhibitor Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory and Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment in the past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 33 patients were planned to be treated with tislelizumab combined with cetuximab + irinotecan every 2 weeks. The enrollment time is expected to be 12 months and the follow-up is 24 months.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	TEC	tislelizumab（an anti-PD-1 monoclonal antibody）+cetuximab（monoclonal antibody against EGFR）+irinotecan

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-12-12
• Completion: 2024-02-28
• First posted: 2021-12-03
• Last updated: 2023-03-28

Locations

1 site across 1 country: China