Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma

The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Inclusion Criteria:

• Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or with non-invasive criteria, according to the clinical practice guidelines by the American Association for the Study of Liver Diseases (AASLD) during a maximum period of 15 days prior to the baseline visit.
• Males and females, over 18 years of age.
• Patients who have not previously received treatment with sorafenib.
• Have an ECOG ≤ 2.
• Liver function: Child A and B7.
• Life expectancy greater than 12 weeks.
• Adequate kidney function: serum creatinine concentration less than or equal to 1.5 times the upper limit of normal (ULN).
• Sign the written informed consent before starting any procedure, including randomization.

Exclusion Criteria:

• Patients who routinely (more than 3 times a week) take some sort of statin.
• Patients with hypersensitivity to statins.
• Pregnant or breastfeeding women.
• Peripheral neuropathy: grade 2 or higher
• Patients who have been diagnosed, within the previous 5 years, with another type of tumor, except for non-melanoma skin cancer, or in situ carcinoma of the cervix or the urinary bladder.
• Patients receiving chemotherapy or radiotherapy for another type of tumor.
• Patients with heart failure greater than NYHA grade II, hypertension that is uncontrolled with medication, uncontrolled arrhythmias or AMI within the previous six months.
• A history of perforation or hemorrhage due to a gastroduodenal ulcus within the last month.
• Greater hemorrhagic diseases.
• Asthmatic patients uncontrolled with medication.
• Any other contraindication associated to the use of statins.
• Physical or psychological inability to participate in the trial.
• Treatment with another investigational drug or participation in another clinical trial within 6 months prior to inclusion in the study.