NCT05028829 · Raymond Chung
Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk
(TORCH)
What this study is about
forward-looking randomly assigned, multi-center, double blind compared against an inactive treatment trial to assess the chemopreventive impact of atorvastatin (20 mg taken by mouth) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.
View original scientific description
Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.
Interventions
DRUG
Atorvastatin 20mg
Oral administration of atorvastatin 20 mg
DRUG
Placebo
Oral administration of placebo
Primary outcome measures
Reduced magnitude of high-risk PLSec after treatment vs before treatment
Time frame: 48 weeks
The primary objective (primary endpoint) of this study is to determine the effect of atorvastatin compared with placebo on HCC risk level measured by change in serum-based prognostic liver secretome signature (PLSec) score (delta-PLSec). High-risk for HCC is indicated by a PLSec score of 3 or greater. Low-risk for HCC is indicated by a PLSec score below 3.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Willing and able to provide informed consent 2. Male or female age \> 18 years at time of consent 3. Clinically or histologically diagnosed advanced liver fibrosis or cirrhosis, as defined by one or more of the following:
- Liver biopsy demonstrating advanced fibrosis or cirrhosis (METAVIR 3-4)
- Fibroscan or MR elastography consistent with advanced fibrosis or cirrhosis
- Imaging showing cirrhotic-appearing liver with signs of portal hypertension
- Advanced fibrosis or cirrhosis documented clinically by a treating physician 4. High-risk for HCC at screening according to the FIB-4 index 5. PLSec score ≥ 3 measured in screening blood samples from the FIB-4-high individuals. 6. Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC 7. Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 8. Willing and able to undergo proto
Where
- Boston, Massachusetts
- Dallas, Texas
Collaborators
University of Texas Southwestern Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations