Hepatic arterial infusion chemotherapy plus regorafenib compared with regorafenib alone as second-line therapy for advanced hepatocellular carcinoma: a randomised controlled trial protocol.

ABSTRACT:

Introduction

The exact role of hepatic arterial infusion chemotherapy (HAIC) in advanced hepatocellular carcinoma (aHCC) is still unknown. The combination of HAIC and sorafenib has been proven to be more effective than sorafenib alone in the first-line treatment of aHCC. The aim of the study is to evaluate the efficacy and safety of HAIC plus regorafenib in the second-line treatment of aHCC.

Methods and analysis

This is a multicenter, open-label, randomised controlled phase III trial. A total of 294 patients with aHCC, who are unable to tolerate the first-line systemic therapy or progress after the first-line systemic therapy, will be enrolled in the study. The patients will be randomly (2:1) assigned into the combination treatment group (HAIC plus regorafenib, n=196) and th

SUBMITTER: Zhao H 

PROVIDER: S-EPMC11628992 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature