Phase II Randomized Trial Evaluating the Administration of Sorafenib or Pravastatin or Association Sorafenib-pravastatin or Best Supportive Care for the Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis
The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in
France. It almost always occurs on liver disease and in 80 to 90% of cases, at least in
France, on liver with cirrhosis. If curative treatment may be proposed for some "small" HCC
(transplantation, resection, percutaneous destruction), about 2 / 3 of patients, which
represents nearly 4,000 new cases per year in France, are not eligible for such treatment.
The palliative management of patients with advanced and symptomatic disease is complex and
requires treatment combining anti-tumor activity and safety in patients with impaired liver
functions. Indeed, in most cases the palliative treatment of HCC is applied to patients with
altered liver function (stage B of the Child-Pugh classification).
To date, the proposed treatment in France for such patients is based on best supportive
The objective of this study is to assess the interest in this situation of 2 molecules -
taken alone or in combination:
- Sorafenib, the reference in the palliative treatment of advanced hepatocellular
carcinoma (Stage C of the BCLC classification). Yet the safety and efficacy of
sorafenib in patients with altered liver function (CHILD B) are not clearly defined and
its use remains discouraged by French recommendations in these patients.
- Pravastatin whose interest in the palliative treatment of HCC was suggested by several
phase II studies with a good safety profile in cirrhotic patients.
In this French multicenter open randomized study, 160 patients will be included in 4 arms
(40/arms): sorafenib, pravastatin, pravastatin + sorafenib, and supportive care.
The aim of this phase II multicenter study is to select the two best arms for further Phase
III study in order to identify a reference treatment in this palliative situation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to radiologic progression
Every 4 weeks (CT-scan or MRI) until progression of HCC or date of last news (for patients alive or dead without progression)
Jean-Frédéric BLANC, MD-PhD
University Hospital, Bordeaux
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)