Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
- Registration Number
- NCT01932385
- Lead Sponsor
- Qingdao Central Hospital
- Brief Summary
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
- pathological or cytological confirmed advanced hepatocellular carcinoma
- 18 years to 80 years
- liver function Child-Pugh class B
- BCLC stage B or C
- estimated life time 2 months or longer
Exclusion Criteria
- previous target therapy
- allergy to Sorafenib
- Uncontrolled Bleeding or diarrhea
- eligible for locoregional treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sorafenib Best Supportive Care sorafenib 400mg, oral, twice a day until disease progression defined by RECIST. Best Supportive Care Best Supportive Care treatment mainly on nutrition and symptoms control sorafenib Sorafenib sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.
- Primary Outcome Measures
Name Time Method progression free survival and overall survival From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
- Secondary Outcome Measures
Name Time Method response rate every 4 weeks till progression, total up to 12 months
Trial Locations
- Locations (1)
Qingdao Central Hospital, Qingdao Cancer Hospital
🇨🇳Qingdao, Shandong, China