Study of Sorafenib and Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)
Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
For the majority of patients, metastatic HCC is incurable and patients should be considered
candidates for clinical trials when appropriate. Till recently there was no worldwide,
approved local or systemic therapy for advanced HCC and the available therapies for advanced
unresectable and/or metastatic HCC have limited clinical values, with low response rates and
little impact on the natural history of the disease. Furthermore, the toxicities associated
with these agents can be severe, requiring careful patient selection, and this dramatically
decreases the number of patients who may benefit from therapy. The SHARP trial established
the survival benefit of Sorafenib in Advanced HCC but the results yet remain humble. The need
for more effective therapies is still there.
Study Objectives
The primary objective of this phase II study is to evaluate the efficacy and safety of
Sorafenib and Gemcitabine combination in patients with advanced HCC.
Safety data and limited efficacy data will be collected for this combination in the study.
All Drug-Related Adverse Events, all Adverse Events NCI CTCAE Version 3.0 Grade 3 or higher,
and all Serious Adverse Events regardless of causal relationship to study drugs will be
recorded in this study.