Last updated on July 2019

Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis


Brief description of study

This randomized 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 Study Description

PRIMARY OBJECTIVES:

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 serum AFP.

II. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in serum IL-6.

III. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in serum bile acid levels.

IV. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in liver stiffness.

V. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in fibrosis 4 index (FIB-4) score.

VI. To evaluate the effect of a simvastatin intervention versus placebo at 6 months from baseline on the change in MELD score.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive simvastatin orally (PO) once daily (QD).

GROUP II: Patients receive placebo PO QD.

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.

Clinical Study Identifier: NCT02968810

Find a site near you

Start Over

University of Puerto Rico

San Juan, Puerto Rico
6.82miles
  Connect »