Advanced Hepatocarcinoma
Conditions
Brief summary
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.
Interventions
DRUGPravastatin
Treatment: Patients will be randomized in two groups, A and B: * Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h. * Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.
Sponsors
INSTITUTO BIODONOSTIA
Hospital Donostia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 18 months | To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | 18 months | To evaluate the time to progression (TTP). |
| time to symptomatic progression (TTSP). | 18 months | To evaluate the time to symptomatic progression (TTSP). |
Countries
Spain
Outcome results
None listed