A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical
resection, liver transplantation, and local ablative therapy.
However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with
portal vein invasion are unresectable and they are not suitable for other curative
therapies. For these patients, the optimal treatment remains largely controversial. As a
palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown
in patients with unresectable HCC and without portal vein invasion by several trials. In
patients with main portal vein invasion, TACE is theoretically contraindicated because of
the potential risk of hepatic failure resulting from ischemia after TACE. However, recent
studies have revealed that TACE could safely be performed in these patients.
The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE)
with adriamycin to transarterial chemoembolization with adriamycin/transarterial
chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with
portal vein invasion.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
every 12 weeks, up to 48 weeks
Jung-Hwan Yoon, M.D., Ph.D.
Seoul National University Hospital
Korea: Institutional Review Board