drugset / Trial / NCT07309289

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

NCT07309289

Phase 3 Recruiting 144 enrolled Shanghai Zhongshan Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-01
Primary completion
2029-03-01
Completion
2029-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 75 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 85 mg/m2 Intravenous
Comparator Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Comparator Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Comparator FOLFOX plus targeted therapy Unknown 400 mg/m2 Intravenous
Background NALIRIFOX plus targeted therapy Unknown 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous
Background l-LV Unknown 200 mg/m2 Intravenous
Comparator l-LV Unknown 200 mg/m2 Intravenous

Indications