NCT05278351

Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRC

Tislelizumab Plus Cetuximab and Irinotecan Comparing the Third-line Standard-of-care Selected by Researchers in the Treatment of Ras Wild-type Recurrent Refractory Metastatic Colorectal Cancer: A Multicenter, Randomized, Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled, phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab and irinotecan（group A） compared to third-line regimens selected by researchers（group B） in the treatment of Ras wild-type recurrent and refractory metastatic colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment inthe past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 87 patients will be randomly assigned to group A and group B according to 2:1. The enrollment time is expected to be 12 months and the follow-up is expected to be 24 months.

Conditions

• Colorectal Neoplasms Malignant

Interventions

Type	Name	Description
DRUG	Tislelizumab Combined With Cetuximab and Irinotecan	Tislelizumab (an anti-PD-1 monoclonal antibody) Cetuximab (monoclonal antibody against EGFR) Irinotecan
DRUG	Third-line regimens	Trifluridinetipiracil or Regorafenib or Fruquintinib

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-04-01
• Completion: 2025-12-01
• First posted: 2022-03-14
• Last updated: 2023-03-31

Locations

1 site across 1 country: China