First-Line Treatment of Liver-Only Metastatic Colorectal Cancer Using Systemic or Intra-arterial Oxaliplatin with LV5FU2, Irinotecan, and Targeted Therapy

What this Trial Is About

Colorectal cancer is a leading cause of cancer-related death, with many patients developing liver metastases that are often difficult to remove surgically. This trial focuses on first-line treatment for patients with metastatic colorectal cancer limited to the liver, aiming to evaluate the effectiveness of combining systemic chemotherapy, targeted therapies, and intra-arterial oxaliplatin chemotherapy. The study seeks to improve tumor response rates, progression-free survival, and overall survival in this patient group. Participants will receive one of four treatment regimens involving combinations of oxaliplatin administered either intra-arterially or intravenously, along with folinic acid, 5-fluorouracil 5-FU, irinotecan, and targeted therapies such as panitumumab or bevacizumab depending on RAS mutation status. Treatment cycles occur every 15 days, with dosing tailored to each arm including variations in drug delivery methods and combinations. The trial includes both experimental and reference treatment arms to compare outcomes. Throughout the study, participants will be monitored for progression-free survival up to 24 months after randomization. Assessments include measuring tumor response by RECIST criteria and evaluating liver metastases. Safety and tolerability will be tracked through laboratory tests and clinical evaluations, while participants eligibility and health status will be closely followed. The study duration extends up to 2028, with ongoing data collection to assess long-term outcomes and treatment effects.

Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver