Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer — CEIL  

Metastatic Colorectal Cancer Clinical Trial

Official title: Cetuximab and Envafolimab Plus mFOLFOXIRI Versus Cetuximab Plus mFOLFOX6/FOLFIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer: A Randomized Controlled Phase II Trial (CEIL)

Status Recruiting

Clinical Trial Summary

The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6/FOLFIRI as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.

Clinical Trial Description

This is a prospective, open-label, multicentric, randomized controlled phase II trial in which patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side mCRC will be randomized to two therapy groups:

Experimental arm A: receive induction treatment with cetuximab and envafolimab plus mFOLFOXIRI up to 8 cycles followed by maintenance with cetuximab and envafolimab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal.

Standard arm B: receive induction treatment with cetuximab plus mFOLFOX6/FOLFIRI up to 8 cycles followed by maintenance with cetuximab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal.

The second- and subsequent lines of treatment will be at investigators' choice. ;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT05959356
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Yanhong Deng, Ph.D
• Phone: 86-13925106525
• Email: 13925106525@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 9, 2023
• Completion date: December 31, 2027