c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI

Colorectal Cancer Clinical Trial

Official title: Second-line Irinotecan Combined With Cetuximab (c-CetuIRI) Versus Second-line Irinotecan Three-line Irinotecan Plus Cetuximab (s-IRI-CetuIRI) in the Treatment of Oxaliplatin and 5-FU Phase II Clinical Study of Wild-type Advanced Colorectal Cancer With RAS Gene

Status Recruiting

Clinical Trial Summary

The primary endpoint is to evaluate the progression-free survival (PFS).

Clinical Trial Description

This study was designed for patients with advanced bowel cancer after first-line LOHP and 5-FU treatment failure. The control group was treated with second-line CPT-11+C225. The study group used second-line CPT-11 single drug until the third line was CPT-11+C225. treatment. Referring to the previous literature data, the PFS of the second-line treatment of CPT-11+C225 is about 4 months. This study assumes that the total PFS time of C225 can be extended to 7 months after the failure of second-line CPT-11 treatment compared with the direct second-line combination. , set α = 0.05, β = 0.2, the expected enrollment time is 2 years, the follow-up time is 1 year, the 10% sample shedding rate, the total sample size is about 60 cases per group, a total of 120 cases. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT04833036
• Study type: Interventional
• Source: Fudan University
• Contact: Weijian Guo, Professor
• Phone: 86-21-64175590
• Email: mingzhuhuang0718@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Completion date: November 2022