Can Aspirin Reduce the Risk of Hepatocellular Carcinoma (HCC) in Participants With Cirrhosis: a Multicentre, Placebo-controlled Clinical Trial - The AspiRe HCC Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 890
- 主要终点
- Overall incidence of HCC in participants receiving aspirin or placebo
研究概览
简要总结
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.
详细描述
The AspiRe HCC trial is a large clinical study designed to find out whether daily low-dose aspirin (100 mg) can help prevent hepatocellular carcinoma (HCC)-the most common form of liver cancer-in people who already have liver cirrhosis.
HCC rates are rising in Australia and worldwide and more than 90% of HCC cases occur in people with cirrhosis. Less than 20% of people with cirrhosis have HCC diagnosed early enough for it to be curable. Diagnosis of HCC at an early stage increases the chances of being able to cure it or stop it from growing or spreading. Previous research suggests aspirin may reduce the risk of developing HCC by 50-70%, with stronger benefits in people who already have cirrhosis.
Ideally, we need to prevent HCC developing in the first place. However, there is no current treatment to preventing HCC in people with cirrhosis.
Experimental studies in animals and humans have shown that that aspirin treatment is safe and may prevent HCC, reducing the risk by at least 50% in people with cirrhosis. Studies from around the world have shown that people taking low-dose aspirin (100 mg daily or sometimes called "mini-aspirin") for other reasons (such as for heart disease or stroke prevention) have a much lower risk of developing HCC. Importantly, people who use aspirin in these settings do not seem to have any increase in the rates of side effects compared to people who do not take aspirin.
If proven effective, aspirin could become a simple and affordable preventative treatment, potentially saving hundreds of lives each year and reducing healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Placebo
Placebo, once daily for 4 years or until diagnosis of HCC
干预措施: Placebo Comparator (Drug)
Low dose Aspirin
Low dose aspirin, 100mg, once daily for 4 years or until diagnosis of HCC
干预措施: Low-dose aspirin (Drug)
结局指标
主要结局
Overall incidence of HCC in participants receiving aspirin or placebo
时间窗: Randomisation to End of study - 4 years treatment
Incidence of HCC, which is defined as the presence or absence of HCC at study completion in participants receiving aspirin compared to placebo
次要结局
- 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)
- Resource Utilization and Cost-effectiveness of Treatment(Randomisation to End of study - 4 years treatment)