Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT01903694|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : May 13, 2014
Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on Child-Pugh A cirrhosis who are unsuitable for curative treatment.
Secondary objectives: evaluate the effect of this treatment on progression-free survival, the time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT HEP)
|Condition or disease||Intervention/treatment||Phase|
|Child-Pugh A Hepatocellular Carcinoma||Drug: Sorafenib + Pravastatin Drug: Sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||474 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2013|
Active Comparator: sorafenib
800 mg of sorafenib twice daily orally.
Other Name: 800 mg of sorafenib twice daily orally.
800 mg of sorafenib twice daily oral doses associated with 40 mg of pravastatin in a taken per os. Pravastatin will be taken during dinner.
Drug: Sorafenib + Pravastatin
- determination of the tumor according to the evaluation criteria of Response Evaluation Criteria in Solid Tumors [ Time Frame: To be done within the month preceding baseline ]
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): NCT01903694
|CHU de Dijon|
|Dijon, France, 21079|