Statin drug tested to stop liver cancer in cirrhosis patients
NCT ID NCT02968810
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 5 times
Summary
This phase 2 trial tests whether simvastatin, a widely used cholesterol-lowering drug, can prevent liver cancer in 52 adults with liver cirrhosis. Participants take simvastatin and are monitored with blood tests and imaging to see if cancer-related markers change. The goal is to see if this drug can slow or stop the progression from cirrhosis to liver cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- simvastatin (a statin drug used to lower cholesterol)
- What this could lead to
- If it works, this could point toward a way to lower liver cancer risk in people with cirrhosis.
- What could go wrong
- This is a small, early-phase trial with only 52 participants. It measures biological markers, not actual cancer rates, so results may not lead to a proven prevention strategy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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52 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Jul 2026
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed diagnosis of liver cirrhosis assessed by the presence of clinical signs, symptoms, body imaging (ultrasound, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]), or liver biopsy * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Leukocytes \>= 2,500/microliter * Absolute neutrophil count \>= 1,500/microliter * Platelets \>= 50,000/microliter * Hemoglobin \>= 8 g/dL * Total bilirubin =\< 3 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN * Creatinine =\< 1.5 x institutional ULN * Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment; women \>= 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test * The effects of simvastatin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women who are able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * Ability to understand and the willingness to sign a written informed consent document and medical release * Willing and able to comply with trial protocol and follow-up * Have had an abdominal imaging test (CT, MRI, or ultrasound) within the past 18 months Exclusion Criteria: * Prior or current use of statin medication * Current systemic use of medications known to interact with statins and potentially increase toxicity, including gemfibrozil, cyclosporine, danazol, lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, human immunodeficiency virus \[HIV\] protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, or cobicistat-containing products), or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort, bosentan, efavirenz, etravirine, modafinil, nafcillin) * History of adverse effects, intolerance, or allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin (i.e., other statin medications) * Current use of any other investigational agents * Women who are pregnant or breastfeeding; pregnant women are excluded from this study because simvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects; it is not known whether simvastatin 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 simvastatin, breastfeeding should be discontinued if the mother is treated with simvastatin * Prior liver transplant * Prior known or suspected hepatocellular carcinoma * Prior cholangiocarcinoma * Model for end-stage liver disease (MELD) \> 20 * Any lab results that do not meet inclusion criteria after the Screen 1 blood tests * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * History of chronic myopathy * Prior germ cell cancer * History of active malignancy within the past 5 years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score 6 or less) * Known active infection with HIV * Medical contraindications to blood draw (e.g., hemophilia) * Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data * Current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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University of Puerto Rico
San Juan, 00936, Puerto Rico
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