This Phase II Prospective, parallel and open-label randomised control trial will investigate whether a radiotherapy technique (called SABR) can treat early stage liver cancer more effectively than current treatments which use heating probes directly inserted into the tumour or chemotherapy or radioactive particles injected into the blood supply of the tumour. Investigators hypothesize SABR will result in higher rates of freedom from local progression (FFLP) at 2 years compared to percutaneous thermal ablation ± TACE or transarterial therapies (TACE/TARE).The study will also look at other important outcomes such as progression free survival, overall survival, side effects, quality of life and people's experiences of their treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
1\) Histological or radiological diagnosis of single, new HCC with largest diameter =8 cm (BCLC stage 0 or A).
* a) If prior history of HCC, the prior HCC must have been:
* Early stage, solitary HCC, =5 cm in size and,
* Have arisen within a different liver segment to the current HCC and,
* Treated with curative intent therapy \>2 years prior with no evidence of active disease at the site.
* 2\) As per local multidisciplinary HCC meeting consensus patient is suitable for percutaneous thermal ablation and/or transarterial therapies and not suitable for or declined liver resection and not planned for liver transplantation.
* 3\) Child-Pugh score =B7\* with no or diuretic-controlled ascites
* 4\) ECOG performance status =2
* 5\) Platelets =50x109/L, Haemoglobin =80 g/L, Neutrophils =1.0x109/L, INR \<1.8 (except if on therapeutic anticoagulation)
* 6\) 18 years of age or older and able to provide written consent
Exclusion Criteria:
* 1\) Presence of multifocal HCC, macrovascular invasion or extrahepatic disease
* 2\) Prior treatment for any HCC within last 2 years.
* 3\) Clinically evident ascites or hepatic encephalopathy
* 4\) Prior abdominal radiation therapy that would preclude the delivery of protocol defined SABR to the tumour.
* 5\) Untreated Hepatitis B or C
* 6\) Known additional invasive malignancy (excluding non-melanoma skin cancer) that is progressing or required treatment within the last 2 years.
* 7\) Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.