Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
Recruitment status was: Recruiting
Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.
Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.
The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC|
- numbers of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]to evaluate the toxicity of sorafenib in combination with zoledronic acid
- Overall survival (OS), time to progression (TTP) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]to evaluate the efficacy of sorafenib in combination with zoledronic acid
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
|Experimental: Sorafenib and Zoledronic Acid||
Drug: Sorafenib and Zoledronic Acid
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259193
|Liver Cancer Institute|
|Shanghai, Shanghai, China, 200032|