Hepatocellular Carcinoma Clinical Trial
Official title:
Comparison of Efficacy Between Sorafenib Monotherapy vs. Transarterial Chemoembolization -Sorafenib Sequential Therapy in Hepatocellular Carcinoma Patients With Extrahepatic Metastasis
Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be beneficial for controlling intrahepatic tumour. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.
Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic
metastasis (EHM). However, transarterial chemoembolization (TACE) which is a standard therapy
for intermediate stage may be beneficial for controlling intrahepatic tumour, thereby
providing chance of improving survival in HCC patients with EHM.
The investigators aimed to compare the efficacy between the sorafenib monotherapy and
TACE-sorafenib sequential therapy in HCC patients with EHM.
This study is a prospective randomized controlled study being conducted at 6 tertiary
hospitals in South Korea. HCC patients with EHM are being enrolled and randomized into
sorafenib monotherapy or TACE-sorafenib sequential therapy group. Patients with main portal
vein invasion, Child-Pugh class B or C, and history of TACE or previous systemic therapy are
being excluded. The sorafenib monotherapy group receives sorafenib immediately after
randomization while the TACE-sorafenib group receives 2~4 times of TACE before starting
sorafenib. Response evaluation are performed every 2 months, and time to progression (TTP),
progression free survival (PFS), median survival time (MST), and overall survival (OS) which
is the primary outcome measure will be compared.
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