Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01932385

Enrollment

Registered

2013-08-30

Start date

2013-08-01

Completion date

2016-07-30

Last updated

2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival

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.

Interventions

DRUGSorafenib

OTHERBest Supportive Care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
response rate	every 4 weeks till progression, total up to 12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026