RecruitingNAINTERVENTIONAL

A Study of Standard Of Care Versus Radio Ablation in Early Stage HCC

This study is looking at a new way to treat early liver cancer using a type of targeted radiotherapy called SABR. We want to see if SABR is more effective than current treatments, which can involve heating probes, chemotherapy, or radioactive particles. The main goal is to find out if SABR can stop the cancer from growing back in the treated area for longer. We will also check how it affects people's overall health, quality of life, and any side effects it might cause. About 218 people with early liver cancer will take part, some receiving SABR and others getting standard care. We hope this research will help us find better ways to treat liver cancer.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

218

Start

11 May 2026

Estimated completion

01 Apr 2032

Early Hepatocellular Carcinoma

What is this study about?

This research study is comparing a special type of radiation treatment called Stereotactic Ablative Body Radiotherapy (SABR) with the usual treatments for liver cancer that's caught early. SABR is a very precise way to deliver high doses of radiation directly to the cancer, aiming to destroy it while sparing surrounding healthy tissue. The main question we want to answer is whether SABR works better than current treatments at stopping the cancer from growing back in the treated area over two years.

Currently, standard treatments for early liver cancer can include using heat to destroy the tumour (which involves probes inserted directly into the cancer), or treatments that deliver chemotherapy or radioactive particles through the blood vessels that feed the tumour. This study will involve people being randomly put into one of two groups: one group will receive SABR, and the other will receive one of the standard treatments. By comparing these groups, we hope to understand if SABR offers a better way to tackle this type of cancer.

Besides looking at how effectively the treatments stop the cancer from growing, we'll also be carefully checking other important things. This includes how long people live without their cancer getting worse, their overall survival, what side effects they experience, and how the treatments affect their day-to-day life and wellbeing. We're also interested in understanding people's experiences with their treatment. All this information will help us decide if SABR could become a better treatment option in the future for people with early liver cancer.

Key takeaways

Compares a new targeted radiotherapy (SABR) with usual treatments for early liver cancer.
Aims to see if SABR stops cancer growth more effectively.
Also studies side effects, quality of life, and patient experiences.
About 218 participants will be randomly assigned to SABR or standard care.
Participation involves close medical monitoring and questionnaires.
You can leave the study at any time.

Who may be eligible?

This study is looking for people who have been recently diagnosed with liver cancer, specifically a single tumour that's not too large (up to 8cm). It’s for those whose current cancer is the first time they've had it, or if they had a small, early-stage liver cancer treated successfully in a different part of their liver more than two years ago.

To join, doctors must agree that you're suitable for the standard treatments like heat-based treatments or ones delivered through blood vessels, but not for surgery to remove the tumour or a liver transplant at this time. You also need to be reasonably fit and well enough to take part, with good liver function, and not have other serious health problems like active Hepatitis B or C or another cancer that's currently active. You must be at least 18 years old.

People who have multiple liver tumours, cancer that has spread outside the liver, or had previous treatment for liver cancer within the last two years cannot join. If you are pregnant or have certain other medical conditions, or have had a lot of radiation to your stomach area before, you won't be able to participate. This is to make sure the study is safe and that we can properly compare the treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a single, newly diagnosed liver tumour up to 8cm?
Have I been told I can't have surgery or a liver transplant at this time?
Am I generally well, without severe liver problems or other active cancers?
Am I at least 18 years old?
Have I NOT had any treatment for liver cancer in the past 2 years (unless it was a very small, cured lump in a different area)?
Am I NOT pregnant and do I NOT have multiple tumours or cancer spread elsewhere?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two treatment groups: either you'll receive the special radiotherapy called SABR, or you'll receive one of the standard treatments for early liver cancer. This might be a heat-based treatment or one delivered through the blood vessels. You will have regular appointments for scans and check-ups to monitor your health, how your treatment is working, and to manage any side effects. You'll also be asked to complete questionnaires about your quality of life. The exact number of visits and the total length of your participation will depend on the treatment you receive and how you respond, but the study will follow people for at least two years to understand the long-term effects.

Potential risks and benefits

Participating in this study might offer you access to a new, potentially more effective treatment for your liver cancer (SABR) that isn't widely available yet, and you will be closely monitored by a medical team. However, as with any medical treatment, there are potential risks and side effects associated with both SABR and the standard treatments. These will be fully explained by the study team, and you'll have the opportunity to ask questions. You are completely free to decide if you want to take part, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Trans Tasman Radiation Oncology Group
Verified postcode
Waratah, Australia· Recruiting
University Health Network - Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is SABR?

SABR is a very precise type of radiotherapy that delivers high doses of radiation directly to your liver tumour, aiming to destroy it while limiting damage to healthy surrounding tissue.

Will I definitely get the new SABR treatment?

No, you will be randomly assigned to receive either SABR or one of the current standard treatments, like heating the tumour or specific drug treatments through your blood vessels. Neither you nor your doctor can choose which treatment you get.

What kind of liver cancer is this study for?

This study is for early-stage liver cancer where there is a single tumour that has been recently diagnosed.

How long will I be in the study?

The study will follow participants for at least two years to see the long-term effects of the treatments.

What are the standard treatments being compared?

Standard treatments include using heat to destroy the tumour, or treatments that deliver chemotherapy or radioactive particles directly to the tumour through its blood supply.

How to find out more

Michael Yan, MD MPH FRCPC DABR

michael.yan@uhn.ca (416) 946-2320 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.