NCT07309289

NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer

NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.

Detailed description

This is a multicentre, open-label, randomised study to explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.

Conditions

• Metastatic Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	NALIRIFOX plus targeted therapy	Drug: Irinotecan Liposome Irinotecan liposome injection will be administered by an intravenous infusion at the dose of 50 mg/m\^2, d1, 14 days per cycle. Drug: Oxaliplatin 75 mg/m\^2, intravenously infusion, d1, 14 days per cycle. Drug: 5-FU 2400mg/m\^2, intravenous infusion, d1-2, 14 days per cycle. Drug: LV/l-LV 400mg/m\^2 or 200mg/m\^2 , intravenous infusion, d1, 14 days per cycle. Drug: Bevacizumab 5mg/kg, intravenous infusion, d1, 14 days per cycle. Drug: Cetuximab 500mg/m\^2, intravenous infusion, d1, 14 days per cycle.
DRUG	FOLFOX plus targeted therapy	Drug: Oxaliplatin 85 mg/m\^2, intravenously infusion, d1, 14 days per cycle. Drug: 5-FU 2400mg/m\^2, intravenous infusion, d1-2, 14 days per cycle. Drug: LV/l-LV 400mg/m\^2 or 200mg/m\^2 , intravenous infusion, d1, 14 days per cycle. Drug: Bevacizumab 5mg/kg, intravenous infusion, d1, 14 days per cycle. Drug: Cetuximab 500mg/m\^2, intravenous infusion, d1, 14 days per cycle.

Timeline

• Start date: 2025-07-01
• Primary completion: 2029-03-01
• Completion: 2029-09-01
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China