Hepatocellular Carcinoma, Metastasis
Conditions
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.
Interventions
Standard therapy for intermediate HCC, but nor for advanced HCC
DRUGSorafenib
Standard therapy for advanced HCC
Sponsors
Korean Liver Cancer Study Group
Korea University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sorafenib monotherapy vs. transarterial chemoembolization-sorafenib sequential therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactHyung Joon Yim, M.D.
Outcome results
None listed