Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence

This is an interventional prevention trial for Hepatocellular Carcinoma Read More

Inclusion Criteria:

• Age ≥18 years
• Confirmed diagnosis of liver cirrhosis (Child-Pugh A or B) assessed by the presence of clinical signs, symptoms, body imaging, or liver biopsy

• Diagnosis of HCC falling within one of the following criteria prior to LRT. Criteria fulfillment will be confirmed by the Imaging Charter and MedQIA.

  1. One lesion ≤ 5 cm or two to three lesions, each ≤ 3 cm.
  2. One lesion > 5 cm and ≤ 8 cm.
  3. Two or three lesions, of which at least one is > 3 cm and all are ≤ 5 cm each. The sum of all diameters must be ≤ 8 cm.
  4. Four or five lesions, each < 3 cm. The sum of all diameters must be ≤ 8 cm.
• Initiation of LRT (according to clinical judgement) within 24 months prior to Screening Visit, with adequate response as determined by Imaging Charter and MedQIA.
• ECOG performance status ≤1 (Karnofsky ≥70%; see Appendix A)
• AST (SGOT) & ALT (SGPT) ≤5 × institutional ULN
• AFP < 400 ng/mL
• Ability to understand and the willingness to sign a written informed consent document and medical release
• Agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; for women who are able to become pregnant.
• Willing and able to comply with trial protocol and follow-up

Exclusion Criteria:

• Current use of statin medication or statin use within 12 months of Screening visit.
• Current systemic use of medications known to interact with statins and potentially increase toxicity, including (e.g., gemfibrozil, cyclosporine, clarithromycin, colchicine, niacin and fibrates).
• History of adverse effects, intolerance, or allergic reactions attributed to compounds of similar chemical or biologic composition to pravastatin (i.e., other statin medications)
• Current use of any other investigational agents
• Women who are pregnant. Women who are able to become pregnant must have a confirmed negative pregnancy test prior to enrollment.
• Women who are breastfeeding. It is not known whether pravastatin is excreted into human milk; however, a small amount of another drug in this class does pass into breast milk. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pravastatin, breastfeeding should be discontinued if the mother is treated with pravastatin.
• Prior liver transplant
• MELD score ≥30.
• History of chronic myopathy
• Active malignancy within the past 5 years (excluding HCC, basal/squamous cell skin cancer, or prostate cancer with a Gleason score 6 or less)
• Known HIV infection
• Hemophilia
• Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data
• Concurrent excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)