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Updated: Jul 8, 2026

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An Oncogenic Hepatocyte-Induced Orthotopic Mouse Model of Hepatocellular Cancer Arising in the Setting of Hepatic Inflammation and Fibrosis
Published on: September 12, 2019
Sorafenib: in hepatocellular carcinoma
Dene Simpson1, Gillian M Keating
1Wolters Kluwer Health | Adis, Auckland, New Zealand.
Drugs
|January 17, 2008
Summary
Sorafenib, an oral multikinase inhibitor, significantly improves survival for advanced hepatocellular carcinoma patients. Combination therapy with doxorubicin also shows survival benefits, with sorafenib generally well-tolerated.
Area of Science:
- Hepatocellular Carcinoma Research
- Oncology Therapeutics
- Clinical Trial Analysis
Background:
- Hepatocellular carcinoma (HCC) is a significant global health concern.
- Sorafenib is an approved oral multikinase inhibitor for advanced HCC.
- Effective treatment options for advanced HCC remain critical.
Purpose of the Study:
- To evaluate the efficacy and safety of sorafenib in advanced HCC.
- To assess the potential of combination therapy with sorafenib and doxorubicin in advanced HCC.
- To provide evidence for sorafenib's role in HCC management.
Main Methods:
- Phase III SHARP trial (n=602) assessed sorafenib monotherapy vs. placebo in advanced HCC.
- Phase II study (n=96) evaluated sorafenib plus doxorubicin vs. doxorubicin alone in advanced HCC.
- Both studies were randomized, double-blind, and multicentre.
Main Results:
- Sorafenib significantly improved median survival (10.7 vs. 7.9 months) and time to progression (5.5 vs. 2.8 months) in the SHARP trial.
- Combination therapy demonstrated significantly longer median overall survival and progression-free survival compared to doxorubicin alone.
- Sorafenib monotherapy was generally well-tolerated with a manageable adverse event profile.
Conclusions:
- Sorafenib monotherapy offers significant survival benefits for patients with advanced HCC.
- Combination therapy with sorafenib and doxorubicin presents a promising treatment strategy for advanced HCC.
- Sorafenib exhibits a favorable safety profile in the management of advanced HCC.
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