Not yet recruitingNAINTERVENTIONAL

International Study on Treatment of Liver (HCC) Patients With IRE

This study is gathering information on a treatment called irreversible electroporation (IRE) for adult patients with a type of liver cancer known as hepatocellular carcinoma (HCC). The aim is to understand more about how IRE is used in real medical practice for patients who have been advised it's a suitable option. IRE uses electrical pulses to destroy cancer cells in the liver. This study will collect details about the procedure for patients aged 18 and over who meet certain health criteria. It's important to note that this is an observational study, meaning it collects data from standard treatment rather than testing a brand new drug or method. We want to learn more to help improve care for future patients with liver cancer.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Angiodynamics, Inc.

Enrolment target

Start

01 Feb 2026

Estimated completion

01 Feb 2029

Hepatocellular Carcinoma (HCC)Liver Ablation Liver Cancer, Adult

What is this study about?

This study, called the International Study on Treatment of Liver (HCC) Patients With IRE, is focused on a treatment for a common liver cancer named hepatocellular carcinoma, or HCC. It's for adults and investigates a method called irreversible electroporation, or IRE.

Imagine IRE as a highly targeted way to treat liver tumours without surgery in some cases. It uses precisely controlled electrical pulses to destroy cancer cells, leaving other healthy tissues largely unharmed. This approach is sometimes preferred because it avoids heating or freezing, which can damage nearby important structures like blood vessels. Doctors decide if IRE is suitable for a patient after carefully reviewing their individual situation.

The main goal of this study is to collect detailed information about how IRE is used for patients with HCC. This means looking at how the procedure is done, what happens during and after the treatment, and any effects it might have. By gathering this data from many patients, researchers hope to better understand how well IRE works, its safety, and ultimately improve the care for people with liver cancer in the future.

Key takeaways

This study collects data on a liver cancer treatment called IRE.
It's for adult patients with a type of liver cancer named HCC.
The treatment (IRE) uses electrical pulses to destroy cancer cells.
You won't receive extra treatments or visits for being in the study.
Your standard care from your medical team will not change.
You can decide not to participate or withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult over 18 with a type of liver cancer called HCC. Your liver health generally needs to be quite good, and you should be able to move around and do daily activities without too much trouble. Doctors will also check your overall health using a few scores.

There are also specific checks related to the treatment itself. For example, IRE works best on smaller tumours (less than 3cm) and usually on up to three tumours. You shouldn't have cancer that has spread to other parts of your body. Also, certain blood test results, like those for your kidney and liver function, need to be within a healthy range.

Some things that would mean you can't join include being pregnant, having other active research studies, or having significant heart problems like a pacemaker. Your blood clotting ability also needs to be normal. If you've had previous treatments that involve heating or freezing the tumour, or if your medical team thinks a different treatment is better for you, you wouldn't be able to participate.

Quick self-check

Are you 18 years or older?
Do you have HCC liver cancer?
Is your liver generally healthy (Child-Pugh A)?
Are your tumours smaller than 3cm (and generally up to 3 tumours)?
Has your cancer not spread to other parts of your body?
Do you not have a pacemaker or significant heart problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are found to be eligible for this study, your involvement would primarily revolve around your standard medical care for liver cancer using irreversible electroporation (IRE). This means that you would receive the IRE treatment as recommended by your medical team. The study itself is observational, which means researchers will collect information and data from your routine medical appointments, tests, and the IRE procedure itself. This data typically includes details about your health before the procedure, how the procedure went, and your health afterwards. There are no extra medications or treatments beyond what your doctor would normally prescribe. The total duration of your participation will depend on the follow-up schedule your medical team typically uses for patients undergoing IRE, but it won't involve new visits specifically for the study. You would simply allow your existing medical information to be used for research purposes.

Potential risks and benefits

Participating in this study might offer a small benefit by contributing to a better understanding of liver cancer treatment, which could help future patients. However, the treatment you receive (IRE) is based on your doctor's recommendation for your specific condition, so you would be getting this treatment regardless of joining the study. The risks involved are generally those associated with the IRE procedure itself, such as potential discomfort, bleeding, or other complications, which your doctor will discuss with you. You will not face additional risks by simply allowing your data to be collected. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting the quality of your medical care.

Locations (1)

Manchester Royal Infirmiary
Manchester, United Kingdom

Common questions

What is HCC?

HCC stands for hepatocellular carcinoma, which is the most common type of primary liver cancer that starts in the liver cells.

What is irreversible electroporation (IRE)?

IRE is a treatment that uses short, powerful electrical pulses to create tiny holes in cancer cells, causing them to die, while often sparing important nearby structures.

Is IRE a new or experimental treatment?

IRE is an established treatment option for certain liver tumours. This study is collecting real-world information about its use, not testing if it works.

Will I get extra medical care if I join the study?

No, your medical care will be exactly the same whether you join the study or not. The study only collects information from your routine treatment.

Can I stop being part of the study if I change my mind?

Yes, you can decide to withdraw from the study at any point without it affecting your medical treatment or care.

How to find out more

Mitchell Vanderpoll

mvanderpoll@angiodynamics.com +44 7790921819 Official trial record

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