Can Aspirin Reduce the Risk of HCC in Cirrhosis: The AspiRe HCC Trial
AspiRe HCC
3 other identifiers
interventional
890
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2026
CompletedFirst Posted
Study publicly available on registry
April 14, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
Study Completion
Last participant's last visit for all outcomes
June 30, 2030
April 14, 2026
April 1, 2026
4.1 years
March 19, 2026
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall incidence of HCC in participants receiving aspirin or placebo
Incidence of HCC, which is defined as the presence or absence of HCC at study completion in participants receiving aspirin compared to placebo
Randomisation to End of study - 4 years treatment
Secondary Outcomes (6)
Number of Adverse Events
Randomisation to End of study - 4 years treatment
Treatment Compliance
Randomisation to End of study - 4 years treatment
Hospital admissions for clinical complications of cirrhosis
Randomisation to End of study - 4 years treatment
Quality of Life (QOL) - EQ-5D-5L
Randomisation to End of study - 4 years treatment
Quality of Life (QOL) - CLDQ
Randomisation to End of study - 4 years treatment
- +1 more secondary outcomes
Study Arms (2)
Low dose Aspirin
ACTIVE COMPARATORLow dose aspirin, 100mg, once daily for 4 years or until diagnosis of HCC
Placebo
PLACEBO COMPARATORPlacebo, once daily for 4 years or until diagnosis of HCC
Interventions
a capsule containing100mg Low Dose Aspirin
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John K Olynyk, BMedSc MBBS FRACP MD FAASLD
Curtin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2026
First Posted
April 14, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share