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NCT07529262Not yet recruitingPhase 3

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

Can Aspirin Reduce the Risk of Hepatocellular Carcinoma (HCC) in Participants With Cirrhosis: a Multicentre, Placebo-controlled Clinical Trial - The AspiRe HCC Trial

Source: ClinicalTrials.gov · Last updated 14 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
890 (estimated)
First submitted
19 Mar 2026
Start date
1 Jun 2026
Primary completion date
30 Jun 2030
Lead sponsor
Curtin University
NCT number
NCT07529262

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 890
  • From 1 Jun 2026 to the primary completion date, 30 Jun 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • Any of the following:
    • autoimmune liver disease.
    • primary biliary cholangitis.
    • primary sclerosing cholangitis.
    • prior HCC
    • alcohol consumption \>3 standard drinks per day in men and 2 standard drinks per day in women.
    • currently taking a nonsteroidal anti-inflammatory drug, anticoagulant drugs, non-vitamin K anticoagulant frugs, or other antiplatelet drugs, including aspirin, within the last 6 months.
    • a known bleeding disorder
    • a platelet count \<50 x 109/L.
    • known history or endoscopic evidence of high risk oesophageal (grade 2 or higher) or gastric varices or, a history of bleeding varices.
    • chronic iron deficiency anaemia.
    • a prior history of liver decompensation or liver transplantation.
    • known peptic ulcer disease.
    • chronic kidney disease with eGFR \<50ml/min; a contraindication to aspirin.
    • Any participant considered by the PI to be deemed unlikely to complete the study due to other comorbid conditions or poor compliance will also be excluded.
    • Pregnancy:

Other

  • Whilst low dose aspirin is considered safe in pregnancy, male and female participants of child-bearing potential are recommended use effective contraception during this trial.
  • Any female participants who fall pregnant during the trial will be withdrawn if their treating obstetric doctor advises that you should do so.

Who the study is looking for

  • Provide written informed consent to participate in the trial according to ICH GCP (R3) and national/local regulations.
  • Diagnosed with liver cirrhosis for at least 6 months
  • Has a current Child-Pugh score ≤6 (Child A - clinically and biochemically compensated cirrhosis)
  • Has been participating in ultrasound or non-ultrasound (computed tomography (CT) or magnetic resonance imaging (MRI)) based surveillance for at least 6 months prior to entry.
  • Has not had any focal lesions, other than haemangiomas, detected during the past 6 months.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.