NCT02968810

Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis

Statin Therapy to Reduce Disease Progression From Liver Cirrhosis to Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cirrhosis
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Simvastatin	Given PO

Timeline

• Start date: 2017-06-21
• Primary completion: 2023-05-03
• Completion: 2026-12-23
• First posted: 2016-11-21
• Last updated: 2026-04-13
• Results posted: 2025-04-15

Locations

5 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study