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

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.