Comparison of Efficacy Between Sorafenib Monotherapy vs. Transarterial Chemoembolization -Sorafenib Sequential Therapy in Hepatocellular Carcinoma Patients With Extrahepatic Metastasis
试验速览
- 阶段
- 4 期
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sorafenib monotherapy arm
The sorafenib monotherapy group receives sorafenib immediately after randomization.
干预措施: Sorafenib (Drug)
TACE-sorafenib sequential therapy arm
TACE(transarterial chemoembolization )-sorafenib group receives 2~4 times of TACE before starting sorafenib.
干预措施: transarterial chemoembolization (TACE) (Procedure)
TACE-sorafenib sequential therapy arm
TACE(transarterial chemoembolization )-sorafenib group receives 2~4 times of TACE before starting sorafenib.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall survival
时间窗: 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
次要结局
- 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))
- 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))
- 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))