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Can Aspirin Reduce the Risk of HCC in Cirrhosis: The AspiRe HCC Trial

NCT07529262 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2026-04-14

No results posted yet for this study

Summary

This clinical trial is testing whether taking a low dose aspirin tablet (100 mg) once a day can help prevent liver cancer (hepatocellular carcinoma, HCC) in people who have cirrhosis, which is severe scarring of the liver. People with cirrhosis have a higher risk of developing HCC. Currently, there is no approved treatment that prevents liver cancer in this group.

Research from around the world suggests that low dose aspirin might reduce the risk of liver cancer by up to half and is safe for people with cirrhosis. However, it is not yet approved for this purpose in Australia. A trial is needed to find out if aspirin really can prevent liver cancer in people with cirrhosis and is safe for these people to use.

890 people from up to 7 hospitals across Australia will take part.

Participants will take medication daily for 4 years. They will be randomly allocated to either aspirin or a placebo (dummy pill).

Participants will continue to have their regular 6 monthly clinic visit with liver ultrasounds and blood tests as part of their normal care.

If at any time liver cancer is found, they will stop the trial.

Participants will also complete some extra tasks:

* Record missed doses or other medications in a small diary.
* Fill in two short quality of life surveys each year.
* Return their medication and diary at their regular 6 monthly appointments.
* In Western Australia only: they will be invited to give optional blood samples for future research.

Conditions

Interventions

DRUG

Low-dose aspirin

a capsule containing100mg Low Dose Aspirin

DRUG

Placebo Comparator

an identical capsule containing no active drug

Sponsors & Collaborators

  • Curtin University

    lead OTHER

Principal Investigators

  • John K Olynyk, BMedSc MBBS FRACP MD FAASLD · Curtin University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2030-06-30
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529262 on ClinicalTrials.gov