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Statins

Atorvastatin for Liver Cancer Risk in Fibrosis (TORCH Trial)

Phase 2
Recruiting
Led By Raymond Chung, MD
Research Sponsored by Raymond Chung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Imaging showing cirrhotic-appearing liver with signs of portal hypertension
Advanced fibrosis or cirrhosis documented clinically by a treating physician
Must not have
Diagnosis of any of the following forms of chronic liver disease:
Active, untreated HCV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 288 weeks

Summary

This trial will compare the effects of atorvastatin vs placebo in people with advanced fibrosis who are at high risk of developing liver cancer.

Who is the study for?
Adults over 18 with advanced liver fibrosis or cirrhosis at high risk for developing liver cancer (HCC) can join. They must be able to take medication as directed and complete study visits. Women who can have children must use birth control, and participants need recent liver imaging. People with other major illnesses, certain chronic liver diseases, uncontrolled infections like HIV or hepatitis B, a history of drug abuse, or those on statins recently cannot join.
What is being tested?
The trial is testing if Atorvastatin (20 mg daily pill) prevents liver cancer better than a placebo in people with serious scarring of the liver due to disease. It's a controlled test where neither doctors nor patients know who gets the real medicine versus a fake pill to ensure unbiased results.
What are the potential side effects?
Atorvastatin may cause muscle pain or weakness, digestive issues like constipation or diarrhea, headache, feeling sick (nausea), nosebleeds and sore throat. Serious side effects are rare but include muscle breakdown leading to kidney damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My scans show a liver condition with increased blood pressure in the portal vein.
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My doctor has confirmed I have advanced fibrosis or cirrhosis.
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My liver is severely scarred, confirmed by tests or a biopsy.
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My liver biopsy shows advanced scarring.
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I am at high risk for liver cancer according to a risk assessment.
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I agree to use birth control as specified by the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a chronic liver disease.
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I have an active hepatitis C infection that hasn't been treated.
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I am willing to stop taking my statin medication for 90 days before the trial starts.
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I am not taking any medications that are not allowed in the study.
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I have uncontrolled chronic hepatitis B.
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I have had surgery to reroute my bile flow.
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I have a liver condition like PBC, PSC, autoimmune hepatitis, A1AT deficiency, Wilson disease, hemochromatosis, iron overload, or a history of drug-induced liver injury.
Select...
My liver condition is severe, classified as Child's Pugh B or C.
Select...
I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~288 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 288 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduced magnitude of high-risk PLSec after treatment vs before treatment
Secondary study objectives
Complete adverse event profile
Complete profile of change in quality of life for patients
Other study objectives
Exploratory Endpoint: Assess the difference in HCC incidence rate between treatment groups
Exploratory Endpoint: Assessment of Immunohistochemical Markers of Pre/Neoplastic Foci
Exploratory Endpoint: Assessment of Pharmacodynamic (PD) Biomarkers of Atorvastatin
+3 more

Side effects data

From 2013 Phase 4 trial • 134 Patients • NCT01660191
11%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rosuvastatin 5 mg
Atorvastatin 20mg
Pitavastatin 4mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: Atorvastatin 20 mgExperimental Treatment1 Intervention
Atorvastatin 20mg will be administered daily via oral route for 48 consecutive weeks on an outpatient basis.
Group II: Group B: Placebo to Match (PTM)Placebo Group1 Intervention
PTM will be administered daily via oral route for 48 consecutive weeks on an outpatient basis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atorvastatin 20mg
2012
Completed Phase 4
~1580

Find a Location

Who is running the clinical trial?

Raymond ChungLead Sponsor
2 Previous Clinical Trials
44 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,088 Previous Clinical Trials
1,059,660 Total Patients Enrolled
7 Trials studying Liver Cirrhosis
7,082 Patients Enrolled for Liver Cirrhosis
Raymond Chung, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
632 Total Patients Enrolled

Media Library

Atorvastatin (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT05028829 — Phase 2
Liver Cirrhosis Research Study Groups: Group A: Atorvastatin 20 mg, Group B: Placebo to Match (PTM)
Liver Cirrhosis Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT05028829 — Phase 2
Atorvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028829 — Phase 2
~25 spots leftby Mar 2026
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