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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT07529262

Run by

Curtin University

People needed

890

Starts

2026-06-01

Expected to finish

2030-06-30

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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.

Full record on ClinicalTrials.gov

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