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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 288 weeks
Awards & highlights
TORCH Trial 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.Check my eligibility
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.See study design
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.
TORCH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show a liver condition with increased blood pressure in the portal vein.
Select...
My doctor has confirmed I have advanced fibrosis or cirrhosis.
Select...
My liver is severely scarred, confirmed by tests or a biopsy.
Select...
My liver biopsy shows advanced scarring.
Select...
I am at high risk for liver cancer according to a risk assessment.
Select...
I agree to use birth control as specified by the study.
TORCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 288 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~288 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduced magnitude of high-risk PLSec after treatment vs before treatment
Secondary outcome measures
Complete adverse event profile
Complete profile of change in quality of life for patients
Other outcome measures
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 moreSide effects data
From 2013 Phase 4 trial • 134 Patients • NCT0166019111%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rosuvastatin 5 mg
Atorvastatin 20mg
Pitavastatin 4mg
TORCH 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
1,047 Previous Clinical Trials
1,053,739 Total Patients Enrolled
Raymond Chung, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
632 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can follow the medication schedule and attend all study visits.The subject must be able to comply with the instructions for taking the study drug and be able to complete the study schedule of assessments.My scans show a liver condition with increased blood pressure in the portal vein.I have been diagnosed with a chronic liver disease.I have an active hepatitis C infection that hasn't been treated.I am willing to stop taking my statin medication for 90 days before the trial starts.My doctor has confirmed I have advanced fibrosis or cirrhosis.I've had a liver scan in the last 6 months to check for cancer, as I have cirrhosis.You have had a significant problem with alcohol or drug abuse within the past year.I am not taking any medications that are not allowed in the study.I have taken statin medication in the last 90 days.You are allergic to Atorvastatin.I am older than 18 years.I have uncontrolled chronic hepatitis B.I have had surgery to reroute my bile flow.I may want to get pregnant or collect eggs within a month after the study ends.My liver is severely scarred, confirmed by tests or a biopsy.My liver biopsy shows advanced scarring.I am at high risk for liver cancer according to a risk assessment.I agree to use birth control as specified by the study.My hepatitis B is stable with over a year of consistent treatment or no need for medication.I haven't had cancer in the last 5 years, except for certain types cured by surgery.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.You have had or currently have any of the following conditions:My liver condition is severe, classified as Child's Pugh B or C.You experienced a severe and life-threatening medical event during the screening period.I have had a solid organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Atorvastatin 20 mg
- Group 2: Group B: Placebo to Match (PTM)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has there been any prior research done on the efficacy of Atorvastatin 20mg?
"Initially analysed in 2005 at OHSU Hospital, the effects of Atorvastatin 20mg have since been explored through 18705 completed clinical trials. Currently 70 studies are recruiting participants across multiple sites, primarily based in Boston, MA."
Answered by AI
What medical conditions are Atorvastatin 20mg routinely prescribed to address?
"Atorvastatin 20mg can provide relief for those suffering from lipidemias, postoperative thromboembolism and anginal pain."
Answered by AI
Has there ever been a research project like this before?
"Currently, there are 70 Atorvastatin 20mg trials in progress spanning 28 countries and 162 cities. Merck Sharp & Dohme LLC's initial 2005 clinical trial for this medication involved 80 participants across all phases of drug approval, with a total of 18705 trials completed since then."
Answered by AI
What is the current extent of participation in this research endeavor?
"As of 8/22/2022, this trial is not accepting new participants. Originally posted on 9/1/2022, it does not currently have any openings. For those searching for liver fibrosis and Atorvastatin 20mg studies there are 460 and 70 opportunities respectively that remain open to the public."
Answered by AI
Is Atorvastatin 20mg a secure medication for individuals to ingest?
"Although Atorvastatin 20mg has not been proven effective, it is likely safe to use as evidenced by the Phase 2 trial rating of 2."
Answered by AI
Are there any further opportunities to join this investigation?
"Data from clinicaltrials.gov states that this medical investigation is no longer recruiting participants, with an initial post date of September 1st 2022 and a recent update on the 22nd August 2022. Despite this trial's closure, there are still 530 other trials actively enrolling patients at present."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
Texas
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Average response time
- < 1 Day
Most responsive sites:
- Massachusetts General Hospital: < 24 hours
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