Liver FibrosesPhase 2TORCHNCT05028829
Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk
A Phase 2 study testing Atorvastatin 20mg in people with Liver Fibroses and Cirrhosis, run by Raymond Chung at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibroses, Cirrhosis
- What is being tested?
- Atorvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2023to 1 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent
- Male or female age > 18 years at time of consent
- 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
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- Advanced fibrosis or cirrhosis documented clinically by a treating physician
- High-risk for HCC at screening according to the FIB-4 index
- PLSec score ≥ 3 measured in screening blood samples from the FIB-4-high individuals.
- Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC
- Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Willing and able to undergo protocol blood sampling
- Subject must be able to comply with dosing instructions for study drug administration and able to complete study schedule of assessments
Who cannot join
- Diagnosis of any of the following forms of chronic liver disease:
- alpha-1-antitrypsin (A1AT) deficiency, Wilson disease, hemochromatosis, iron overload, prior known or suspected drug-induced liver injury (DILI)
- Patients with PBC, PSC, AIH, or stable hemochromatosis may be included if their liver disease etiology overlaps with that of steatotic liver disease (SLD)
- Current or prior history of any of the following:
- Clinically significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol
- Known positivity for HIV infection
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- Active, untreated HCV infection
- Patients with prior history of HCV who achieved sustained virologic response (SVR) >12 from Day 1 may be included in the study
- Uncontrolled chronic HBV
- Patients with well controlled disease with >12 months of stable medication use (or no medication use, in those persons for whom anti-HBV therapy is not indicated)
- Clinical hepatic decompensation, defined as Child's Pugh class >B7 or C cirrhosis
- Patients with Child's Pugh score of 7, class B, may be included in the study
- History of biliary diversion
- Solid organ transplant
- Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
- Pregnant or Nursing Females (a negative serum pregnancy test is required at screening for WOCBP)
- Life threatening SAE during the screening period
- Subjects having the following laboratory parameters at screening
- ALT > 10 x ULN
- AST > 10 x ULN
- Hemoglobin < 8.5 g/dl
- Serum creatinine > 2.0 mg/dL
- CK > 3x ULN
- Females who may wish to become pregnant and/or plan to undergo egg harvesting during the study and up to 30 days of the last dose of study drug
- WOCBP must abstain from breastfeeding and be willing to use effective birth control during through the week 4 post treatment follow-up visit
- Clinically relevant alcohol or drug abuse within 12 months of screening
- Use of any prohibited concomitant medications as described in Section 9.1.1
- Use of a statin medication within 90 days of Day 1 visit
- Subjects who are on a current statin at time of consent must be willing to undergo a 90-day washout period prior to randomization
- Known hypersensitivity to atorvastatin
- Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through the week 4 post treatment follow-up visit
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Raymond Chung, MD, Chung.Raymond@mgh.harvard.edu
Raymond Chung, MD
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Yujin Hoshida, MD, Yujin.Hoshida@UTSouthwestern.edu
Yujin Hoshida, MD
About this study
Official title: Multi-center Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Long-term Atorvastatin (20 mg/Day) v. Placebo on HCC Risk in Individuals With Advanced Liver Fibrosis
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.
Read the detailed description
The study objective is to investigate the chemopreventive efficacy of atorvastatin (20 mg) on HCC risk compared to placebo in adults with advanced fibrosis (i.e. METAVIR fibrosis stage 3-4) and high-risk PLSec (defined by pre-randomization blood-based assay). HCC risk will be measured by changes in prognostic liver secretome signature (PLSec) risk score after oral administration of atorvastatin for 1 year with up to 5 years post-treatment of chart monitoring.
- Conditions
- Liver Fibroses, Cirrhosis
- Being tested
- Atorvastatin 20mg, Placebo
- Keywords
- Liver Disease, Chemoprevention, HCC, Atorvastatin
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Also called Lipitor
Oral administration of atorvastatin 20 mg
PlaceboDrug
Oral administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A: Atorvastatin 20 mg | Experimental | Atorvastatin 20mg will be administered daily via oral route for 48 consecutive weeks on an outpatient basis. Receives: Drug: Atorvastatin 20mg |
| Group B: Placebo to Match (PTM) | Placebo comparator | PTM will be administered daily via oral route for 48 consecutive weeks on an outpatient basis. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced magnitude of high-risk PLSec after treatment vs before treatment
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.
Measured: 48 weeks
Secondary outcomes (2)
Complete adverse event profile
Minimized toxicity in response to treatment based on NCI Common Terminology Criteria for Adverse Events (CTCAE) v.5 at least every 4 weeks to week 12 and at weeks 24, 36, and 48.
Measured: 48 weeks
Complete profile of change in quality of life for patients
The investigators will assess the subjects' quality of life while on treatment using the Chronic Liver Disease Questionnaire (CLDQ). A Likert scale response format will be used for all items (n=29), and the overall CLDQ score will be obtained by adding scores for each item and dividing by the total number of items (n=29). The score ranges from 1 (most impairment) to 7 (least impairment).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start10 May 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raymond Chung
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Sponsor-investigator, Raymond Chung, Massachusetts General Hospital
- Investigators
- Raymond Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028829
- Sponsor's protocol ID
- 21-444
- Acronym
- TORCH
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Dr. Raymond T. Chung. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Long-term Atorvastatin (20 mg/Day) v. Placebo on HCC Risk in Individuals With Advanced Liver Fibrosis
- ClinicalTrials.gov ID
- NCT05028829
- Acronym / sponsor ID
- TORCH / 21-444
- Conditions
- Liver Fibroses, Cirrhosis
- Keywords
- Liver Disease, Chemoprevention, HCC, Atorvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Raymond ChungUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study objective is to investigate the chemopreventive efficacy of atorvastatin (20 mg) on HCC risk compared to placebo in adults with advanced fibrosis (i.e. METAVIR fibrosis stage 3-4) and high-risk PLSec (defined by pre-randomization blood-based assay). HCC risk will be measured by changes in prognostic liver secretome signature (PLSec) risk score after oral administration of atorvastatin for 1 year with up to 5 years post-treatment of chart monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Atorvastatin 20 mg | Experimental | Drug: Atorvastatin 20mgAtorvastatin 20mg will be administered daily via oral route for 48 consecutive weeks on an outpatient basis. |
| Group B: Placebo to Match (PTM) | Placebo comparator | Drug: PlaceboPTM will be administered daily via oral route for 48 consecutive weeks on an outpatient basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide informed consent
- Male or female age > 18 years at time of consent
- Clinically or histologically diagnosed advanced liver fibrosis or cirrhosis, as defined by one or more of the following:
- High-risk for HCC at screening according to the FIB-4 index
- PLSec score ≥ 3 measured in screening blood samples from the FIB-4-high individuals.
Key exclusion criteria (31 listed)
- Diagnosis of any of the following forms of chronic liver disease:
- Current or prior history of any of the following:
- Known positivity for HIV infection
- Active, untreated HCV infection
- Uncontrolled chronic HBV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 20mgAlso: LipitorOral administration of atorvastatin 20 mg | Drug | Group A: Atorvastatin 20 mg |
| PlaceboOral administration of placebo | Drug | Group B: Placebo to Match (PTM) |
Primary outcome
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.
2 secondary outcomes
Complete adverse event profile
Time frame: 48 weeks
Complete profile of change in quality of life for patients
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Dr. Raymond T. Chung. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Chung, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 20mg in people with Liver Fibroses and Cirrhosis, run by Raymond Chung at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raymond Chung, MD (617-724-7526, chung.raymond@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced magnitude of high-risk PLSec after treatment vs before treatment (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.