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
- 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
- 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
- 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
- A history of perforation or hemorrhage due to a gastroduodenal ulcus within the last
- 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.