Comparing NALIRIFOX Plus Targeted Therapy to FOLFOX Plus Targeted Therapy as First Treatment for Inoperable Metastatic Colorectal Cancer in a Phase 3 Randomized Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of NALIRIFOX combined with targeted therapy compared to FOLFOX combined with targeted therapy as the first treatment for patients with metastatic colorectal cancer. This is a Phase 3, multicenter, open-label, randomized trial designed to compare these two treatment approaches in people with this advanced cancer. Participants receive either NALIRIFOX plus targeted therapy or FOLFOX plus targeted therapy. NALIRIFOX treatment includes intravenous infusions of irinotecan liposome, oxaliplatin, 5-FU, leucovorin, bevacizumab, and cetuximab given every 14 days in cycles. The comparator group receives FOLFOX plus targeted therapy including oxaliplatin, 5-FU, leucovorin, bevacizumab, and cetuximab, also administered intravenously every 14 days. Both treatments are given as first-line therapy for metastatic colorectal cancer. Participants will be monitored regularly to assess treatment response and safety. Assessments include measuring progression-free survival rates at 18 months, tumor response and control rates up to 12 months, surgical resection outcomes, and overall survival up to 30 months. Study visits involve physical exams, lab tests, and imaging to evaluate disease status and side effects. The study is expected to follow participants for over four years to collect comprehensive data on treatment effects and patient outcomes.

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