Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
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|ClinicalTrials.gov Identifier: NCT01259193|
Recruitment Status : Unknown
Verified October 2010 by Fudan University.
Recruitment status was: Recruiting
First Posted : December 14, 2010
Last Update Posted : April 14, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Sorafenib and Zoledronic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2012|
|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
- numbers of adverse events [ Time Frame: 1 year ]to evaluate the toxicity of sorafenib in combination with zoledronic acid
- Overall survival (OS), time to progression (TTP) [ Time Frame: 1 year ]to evaluate the efficacy of sorafenib in combination with zoledronic acid
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259193
|Contact: Zheng-Gang Ren, Ph.D||0086-021-64041990 ext firstname.lastname@example.org|
|Contact: Lan Zhang, Master||0086-021-64041990 ext email@example.com|
|Liver Cancer Institute||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2137 firstname.lastname@example.org|
|Contact: Lan Zhang, Master 0086-021-64041990 ext 2171 email@example.com|
|Principal Investigator: Zheng-Gang Ren, Ph.D|
|Sub-Investigator: Jubo Zhang, PhD|