NCT03493048

Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM

Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX in Patients With Initially Unresectable Colorectal Liver Metastasis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. The patients will be treated in two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOX + Cetuximab

Detailed description

We intend to carry out a randomized controlled clinical study of cetuximab plus FOLFOXIRI regimen versus cetuximab plus FOLFOX regimen in the first-line treatment of patients with initially unresectable CRLM, to answer the question of whether cetuximab plus FOLFOXIRI regimen can improve the overall ORR, surgical resection rate and OS compared with cetuximab plus FOLFOX regimen in patients with previously untreated, initially unresectable CRLM patients.

Conditions

• Colorectal Cancer
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan 130 mg/m²
DRUG	Cetuximab	Cetuximab, iv, 500mg/m2
DRUG	5-fluorouracil	5-FU 2400 mg/m² cont. inf.
DRUG	Oxaliplatin	oxaliplatin 85 mg/m²
DRUG	Leucovorin	leucovorin 200 mg/m²

Timeline

• Start date: 2018-04-15
• Primary completion: 2022-12-30
• Completion: 2026-06-01
• First posted: 2018-04-10
• Last updated: 2025-08-03

Locations

1 site across 1 country: China