Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis
- Conditions
- MetastasisHepatocellular Carcinoma
- Interventions
- Procedure: transarterial chemoembolization (TACE)
- Registration Number
- NCT03518502
- Lead Sponsor
- Korea University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
- Patients with hepatocellular carcinoma by the European Association for the Study of the Liver (EASL) criteria or pathology
- One or more extrahepatic metastatic lesion by proven radiologically or histologically
- No serious coagulation abnormalities
- Performance status 0 or 1 by Eastern Cooperative Oncology Group(ECOG) criteria
- Child-Pugh score 5 or 6
- Serum creatinine <1.5mg/dL
- Age between 18 ~ 75 years old
- No other life-threatening medical illness
- Patients with main portal vein invasion
- Child-Pugh class B or C
- History of TACE or previous systemic chemotherapy including sorafenib
- Age >75 years old
- Cardiovascular diseases
- History of gastrointestinal bleeding within 2 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TACE-sorafenib sequential therapy arm Sorafenib TACE(transarterial chemoembolization )-sorafenib group receives 2\~4 times of TACE before starting sorafenib. TACE-sorafenib sequential therapy arm transarterial chemoembolization (TACE) TACE(transarterial chemoembolization )-sorafenib group receives 2\~4 times of TACE before starting sorafenib. Sorafenib monotherapy arm Sorafenib The sorafenib monotherapy group receives sorafenib immediately after randomization.
- Primary Outcome Measures
Name Time Method Overall survival 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) Survival rate during the study period
- Secondary Outcome Measures
Name Time Method Time to progression (TTP) 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 form the enrollment to the event of progression
Progression free survival (PFS) 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) Survival rate without progression of HCC
Median survival time (MST) 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 time of the patient survival
Trial Locations
- Locations (6)
Korea University Ansan Hospital
🇰🇷Ansan, Gyeonggi-do, Korea, Republic of
Seoul Saint Marry Hospital, the Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hwasoon Hospital
🇰🇷Gwangju, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Soonchunghyang University Bucheon Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of