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

Colorectal Neoplasms Malignant Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05278351
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact
Status Recruiting
Phase Phase 2
Start date July 13, 2022
Completion date December 1, 2025
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