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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Standard therapy for intermediate HCC, but nor for advanced HCC
Standard therapy for advanced HCC
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
RECRUITINGSoonchunghyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
RECRUITINGKeimyung University Dongsan Hospital
Daegu, South Korea
Overall survival
Survival rate during the study period
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Time to progression (TTP)
Time form the enrollment to the event of progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Progression free survival (PFS)
Survival rate without progression of HCC
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Median survival time (MST)
Median time of the patient survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
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Chonnam National University Hwasoon Hospital
Gwangju, South Korea
RECRUITINGSeoul Saint Marry Hospital, the Catholic University of Korea
Seoul, South Korea
RECRUITINGSeverance Hospital, Yonsei University
Seoul, South Korea
RECRUITING