Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
- To evaluate the effects of sorafenib tosylate and pravastatin versus sorafenib tosylate
alone on overall survival of patients with hepatocellular carcinoma and Child-Pugh
Class A cirrhosis.
- To evaluate the effect of this regimen on progression-free survival, time to
progression, time to treatment failure, and quality of life (QLQ-C30 and FACT hep) in
- To evaluate the benefit of on-site monitoring versus the centralized data management
monitoring of these patients.
- To characterize polymorphisms to specify the haplotype diversity in these patients.
- To test both diagnostic and prognostic signatures by quantitative RT-PCR to determine
if they can predict response to these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, Cancer of the Liver Italian Program (CLIP) score (0 vs 1 vs 2-4), WHO performance
status (0 vs 1 vs 2), portal vein thrombosis (presence vs absence), and extrahepatic
metastases (presence vs absence). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate twice daily on days 1-28 and oral
pravastatin once daily on days 1-28. Courses repeat every 4 weeks in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaires (QLQ-C30 and FACT) at baseline and then
every 4 weeks during and after completion of study therapy.
Blood and tissue samples may be collected for laboratory analysis, including pharmacogenomic
After completion of study therapy, patients are followed up periodically.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Hopital Du Bocage