Trans-arterial chemoembolization (TACE) is the most widely used palliative treatment for BCLC B stage hepatocellular carcinoma (HCC) patients. While a number of studies demonstrated poor effect of TACE for patients with large hepatocellular carcinoma especially for those with tumor that out of up-to-7 criteria. Some recent studies suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large tumor. Thus, the investigators carried out this prospective randomized controlled trial to demonstrate the superiority of neoadjuvant HAIC of TACE.~Total 156 subjects will be recruited in this study, each group of 78 subjects in treatment group (HAIC-TACE-Dona group) and control group (TACE-Dona group). Primary efficacy analysis will be done in the full analysis set. PFS will be used as primary outcome measures. OS, TTP, ORR, DCR and safety will be the secondary endpoints. In addition, the safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0).
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria.