Trial | NCT01932385  Report issue

Title

Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sorafenib ...

  • Study Participants

    86
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.
Study Started
Aug 01
2013
Primary Completion
Jan 30
2016
Study Completion
Jul 30
2016
Last Update
Feb 14
2018

Drug Sorafenib

  • Other names: Nexavar

Other Best Supportive Care

sorafenib Experimental

sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.

Best Supportive Care Active Comparator

treatment mainly on nutrition and symptoms control

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
No Results Posted