60 Participants Needed

Atorvastatin for Liver Cancer Risk in Fibrosis

(TORCH Trial)

Recruiting at 1 trial location
RC
YH
Overseen ByYujin Hoshida, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Raymond Chung
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications, but if you are taking a statin, you must stop it and undergo a 90-day washout period before starting the trial.

What data supports the idea that Atorvastatin for Liver Cancer Risk in Fibrosis is an effective drug?

The available research shows that Atorvastatin, a type of statin, is effective in reducing the risk of liver cancer in people with liver diseases. One study found that statin use, including Atorvastatin, was linked to a 44% reduction in the development of liver scarring and a 49% reduction in new liver cancer cases among patients with hepatitis C. Another study highlighted that Atorvastatin was particularly effective in reducing high-risk patterns associated with liver cancer development. These findings suggest that Atorvastatin is a potent option for lowering liver cancer risk in patients with viral and metabolic liver diseases.12345

What safety data exists for atorvastatin in liver cancer risk and fibrosis treatment?

Atorvastatin is generally well tolerated, but there are concerns about hepatotoxicity, with some cases of liver injury reported. Statins, including atorvastatin, have been associated with idiosyncratic liver injury in 1.9%-5.5% of patients. Most patients recover after stopping the drug, though there have been rare cases of severe liver injury. Despite these risks, statins are being studied for their potential benefits in liver conditions, including cirrhosis and hepatocellular carcinoma prevention.16789

Is the drug Atorvastatin a promising treatment for reducing liver cancer risk in people with liver fibrosis?

Yes, Atorvastatin shows promise in reducing liver cancer risk, especially in patients with liver diseases like hepatitis C and nonalcoholic fatty liver disease. It has been associated with a lower risk of developing liver cancer and slowing down liver damage.2361011

What is the purpose of this trial?

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.

Research Team

RC

Raymond Chung, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion 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.
See 12 more

Exclusion Criteria

ALT > 10 x ULN
Known positivity for HIV infection
I have been diagnosed with a chronic liver disease.
See 26 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atorvastatin or placebo daily for 48 weeks to assess chemopreventive impact on HCC risk

48 weeks
Regular visits every 4 weeks, with additional visits at weeks 12, 24, 36, and 48

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 5-year observational study to examine HCC incidence

5 years

Treatment Details

Interventions

  • Atorvastatin
  • Placebo
Trial Overview 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.
Participant Groups
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.

Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Lipitor for:
  • Hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia
🇺🇸
Approved in United States as Lipitor for:
  • Hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia
  • Prevention of cardiovascular disease
🇨🇦
Approved in Canada as Lipitor for:
  • Hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia
  • Prevention of cardiovascular disease
🇯🇵
Approved in Japan as Lipitor for:
  • Hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia
🇨🇳
Approved in China as Lipitor for:
  • Hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia
🇨🇭
Approved in Switzerland as Lipitor for:
  • Hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Raymond Chung

Lead Sponsor

Trials
3
Recruited
100+

University of Texas Southwestern Medical Center

Collaborator

Trials
1,102
Recruited
1,077,000+

Findings from Research

In a study of over 73,000 patients with newly diagnosed cirrhosis, higher cholesterol levels were linked to better liver function and lower mortality rates, suggesting that hyperlipidemia may have protective effects in these patients.
Each additional year of statin use was associated with an 8.0%-8.7% reduction in mortality for patients with cirrhosis, indicating that statins can be beneficial and should not be avoided due to concerns about liver toxicity.
Effects of Hypercholesterolemia and Statin Exposure on Survival in a Large National Cohort of Patients With Cirrhosis.Kaplan, DE., Serper, MA., Mehta, R., et al.[2019]
In a study of 9,135 patients with chronic hepatitis C, statin use was linked to a 44% reduction in the development of cirrhosis and a 49% reduction in hepatocellular carcinoma (HCC), indicating significant protective effects against liver disease progression.
The effectiveness of statins was dose-dependent, with atorvastatin and fluvastatin showing the most pronounced antifibrotic effects, suggesting that higher doses may provide greater benefits in managing fibrosis and reducing cancer risk.
Atorvastatin and fluvastatin are associated with dose-dependent reductions in cirrhosis and hepatocellular carcinoma, among patients with hepatitis C virus: Results from ERCHIVES.Simon, TG., Bonilla, H., Yan, P., et al.[2022]
Lipophilic statins, especially atorvastatin, significantly reduce the risk of hepatocellular carcinoma (HCC) in patients with chronic viral hepatitis by suppressing high-risk liver gene patterns associated with cancer development.
Atorvastatin uniquely inhibits key pathways (YAP and AKT) involved in liver cancer progression, making it a promising candidate for HCC chemoprevention in patients with liver diseases like hepatitis C and nonalcoholic fatty liver disease.
Atorvastatin favorably modulates a clinical hepatocellular carcinoma risk gene signature.Kim, MH., Kim, MY., Salloum, S., et al.[2022]

References

Effects of Hypercholesterolemia and Statin Exposure on Survival in a Large National Cohort of Patients With Cirrhosis. [2019]
Atorvastatin and fluvastatin are associated with dose-dependent reductions in cirrhosis and hepatocellular carcinoma, among patients with hepatitis C virus: Results from ERCHIVES. [2022]
Atorvastatin favorably modulates a clinical hepatocellular carcinoma risk gene signature. [2022]
Statin Use and Survival with Early-Stage Hepatocellular Carcinoma. [2017]
Chemopreventive Effect of Statin on Hepatocellular Carcinoma in Patients With Nonalcoholic Steatohepatitis Cirrhosis. [2022]
Chemically induced mouse liver tumors are resistant to treatment with atorvastatin. [2022]
Hepatotoxicity of statins and other lipid-lowering agents. [2022]
Emerging role of statin therapy in the prevention and management of cirrhosis, portal hypertension, and HCC. [2023]
Atorvastatin improves disease activity of nonalcoholic steatohepatitis partly through its tumour necrosis factor-α-lowering property. [2022]
Statin use and risk of hepatocellular carcinoma in a U.S. population. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Lipophilic Statins and Risk for Hepatocellular Carcinoma and Death in Patients With Chronic Viral Hepatitis: Results From a Nationwide Swedish Population. [2021]
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