Hepatocellular carcinoma (HCC) mortality is increasing at the most rapid pace of any cancer and is highly lethal with a dismal 5-year survival rate of 18%. Early stage HCCs in patients with cirrhosis can be treated by locoregional therapies (LRT), although the rate of recurrence is high (up to 70%). Liver transplantation is considered a definitive cure for cirrhotics with HCC meeting the Milan Criteria. However, over the last decade, there has been a growing crisis of insufficient donor livers for transplantation. We recently found that early stage HCC patients on a hydrophilic statin (most notably pravastatin) had a suggestion of prolonged survival compared to non-statin users.We will conduct a randomized double-blinded, placebo-controlled trial of a 12-month pravastatin intervention to reduce HCC disease progression in patients with HCC recruited over 3 years. We will focus on patients with early stage cancers (falling within the Milan Criteria) who have completed an initial locoregional therapy. We expect XX participants to complete the 12-month intervention. Participants will provide blood specimens and participate in standard of care imaging tests. We will evaluate the effect of statin versus placebo on: 1. Recurrence-free survival, 2.Time to recurrence, 3.Liver stiffness, 4.Serum biomarkers.
|Effective start/end date||7/6/17 → 5/31/22|
- Cedars-Sinai Medical Center (1427448//1R01CA218466-01)
- National Cancer Institute (1427448//1R01CA218466-01)