Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies how well simvastatin works in preventing liver cancer in patients with liver cirrhosis. Simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the effect of a simvastatin intervention versus placebo on the change in serum AFP-L3% from baseline to 6 months following treatment initiation in patients with liver cirrhosis who have a current model for end-stage liver disease (MELD) =< 20. SECONDARY OBJECTIVES: I. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in: Ia. Serum AFP; Ib. Serum IL-6; Ic. Serum deoxycholic acid; Id. Liver stiffness; Ie. Fibrosis 4 index (FIB-4) score; If. MELD score. EXPLORATORY OBJECTIVES: I. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in other: Ia. serum bile acid levels; Ib. serum immune markers. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive simvastatin orally (PO) once daily (QD). Patients also undergo collection of blood on study and computed tomography (CT) scans/magnetic resonance imaging (MRI) throughout the trial. GROUP II: Patients receive placebo PO QD. Patients also undergo collection of blood on study and CT/MRI throughout the trial. In both groups, treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30, 60, and 90 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02968810
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	June 21, 2017
Completion date	December 31, 2024

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