Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Conditions
Liver Cancer
Conditions: official terms
Carcinoma, Hepatocellular
Conditions: Keywords
Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Sorafenib Type: Drug
Name: Best Supportive Care Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China
Status: Recruiting
Contact: youxin ji, M.D. - 8653268665078
Start Date
August 2013
Completion Date
July 2014
Sponsors
Qingdao Central Hospital
Source
Qingdao Central Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page