Hepatectomy versus TILA-TACE in the treatment of Resectable Hepatocellular Carcinoma: study protocol for a randomized controlled trial

Abstract Abstract Background: Hepatectomy and transcatheter arterial chemoembolization (TACE) are common treatments for hepatocellular carcinoma (HCC). Targeting intratumoral lactic acidosis TACE (TILA-TACE) is a new therapeutic approach developed by our team that has superior response rate and effective rate than conventional TACE (cTACE). In this randomized-controlled trial, we will compare the efficacy of hepatectomy and TILA-TACE in patients clinically diagnosed with HCC to provide reliable clinical data for the subsequent effective treatment of HCC patients. Methods: A total of 230 resectable HCC patients will be given hepatectomy or TILA-TACE using a parallel-controlled approach, and the efficacy of the treatments Page 4 of 24 will be compared. The primary endpoint is the post-treatment progression-free survival (PFS) of the patients, and the secondary endpoints are the post-treatment overall survival (OS), 1-year, 3-year and 5-year survival, and the quality of life of the patients at each corresponding stage. Discussion: The aim of this study is to compare the efficacy of hepatectomy and TILA-TACE in the treatment of resectable HCC. Trial registration: ClinicalTrials.gov,NCT03314532.Registered on 19 October 2017. Keywords: Hepatocellular carcinoma, Hepatectomy, TACE, TILA-TACE, Randomized-controlled study.