Study of FOLFOX Hepatic Arterial Infusion Chemotherapy with Bevacizumab or Cetuximab for Unresectable Colorectal Liver Metastasis to Improve Surgery Rates and Survival

What this Trial Is About

Colorectal cancer often leads to liver metastases, affecting about half of patients and significantly shortening survival. Complete surgical removal of liver metastases can improve outcomes, but most patients initially have tumors that cannot be removed. This study is a Phase 2 trial that evaluates whether combining hepatic arterial infusion chemotherapy with targeted drugs bevacizumab or cetuximab can increase the chance of making previously unresectable colorectal liver metastases removable, aiming to improve long-term survival. Patients in this study receive a combination treatment called FOLFOX-HAIC, which delivers chemotherapy drugs oxaliplatin, leucovorin, and 5-fluorouracil directly into the liver artery. Alongside this, patients receive intravenous bevacizumab or cetuximab based on tumor characteristics. The infusion procedure involves catheter insertion through the femoral artery to target liver tumors. If tumors become operable, liver surgery may be performed. Treatment cycles are repeated approximately every three weeks. Participants will be monitored for tumor response, safety, and conversion to surgery over 180 days and up to 12 months. Evaluations include imaging to measure tumor size, blood tests to assess organ function, and assessments of treatment side effects. The main goal is to see how many patients can proceed to liver surgery. Long-term follow-up will assess survival outcomes and overall safety throughout the study period ending in 2030.

FOLFOX-HAIC as Conversion Treatment for Initially Unresectable Colorectal Liver Metastasis