RecruitingNAINTERVENTIONAL

Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)

This study is exploring a new treatment approach for advanced liver cancer (hepatocellular carcinoma). It combines two types of immune-boosting drugs that are already used to help your body fight cancer, with a special treatment that uses low-energy radio waves. These radio waves create an electromagnetic field around the body, which some research suggests might help treat certain cancers. The researchers want to see if this combination therapy is safe, and how effective it is for patients whose cancer has spread or can't be treated with surgery or other local treatments. They will compare results with patients who received the immune-boosting drugs alone, to understand if adding the radio wave treatment makes a difference. This is an early-stage study to understand if this combined approach is a good option for future, larger trials.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

01 Mar 2025

Estimated completion

28 Feb 2029

Hepatocellular Carcinoma (HCC)

What is this study about?

If you or someone you know has advanced liver cancer, healthcare professionals are always looking for new and better ways to treat it. This study is testing a new combined treatment. Currently, for advanced liver cancer, doctors often use a treatment that helps your body’s own immune system fight the cancer. This is called 'double immune checkpoint inhibition' and it involves two special medications.

What this study is adding to that standard treatment is something called 'radiofrequency electromagnetic field treatment'. Imagine a gentle, low-energy radio wave – it’s not the same as radiation therapy. The idea is that these radio waves create a special field around the body, and some early research suggests this might help in treating certain solid cancers, including liver cancer. This particular hospital in Berlin is one of the only places in Germany with the special equipment to deliver this specific kind of radiofrequency treatment.

The main goal of this study is to see if combining these two immune-boosting medications with this radiofrequency treatment is safe and if it helps people with advanced liver cancer that can't be removed by surgery or other local procedures. The researchers will be comparing results from people in this study with similar patients who received only the two immune medications, to understand if adding the radio wave treatment makes a positive difference. This is a "feasibility trial," which means it's an initial step to see if this combined treatment is something worth investigating further in larger studies.

Key takeaways

Tests a new combination of immune drugs and radiofrequency treatment for advanced liver cancer.
Aims to be a kinder, more effective treatment option.
This is an early-stage study to check safety and feasibility.
Compares outcomes to standard immune treatment alone.
Only available at a specific hospital in Berlin, Germany.
Participation involves regular check-ups, scans, and treatments.

Who may be eligible?

To be able to join this study, there are certain conditions you need to meet. You must be at least 18 years old and have liver cancer that has been confirmed by a doctor. Your cancer should be advanced, meaning it can't be treated with surgery or other local treatments like TACE. You also shouldn't have had any other cancer medications for your liver cancer before. It's important that your liver is still working reasonably well, and you should be generally well enough to go about your daily life without too much difficulty. Women who could become pregnant must use reliable birth control and have a negative pregnancy test.

There are also some reasons why you wouldn't be able to join. For example, if you've had a recent stroke or heart attack (within the last 3 months), or have severe heart problems, you wouldn't be suitable. If you have a pacemaker or other large metal implants in the area where the radiofrequency treatment would be given, that would also prevent you from joining. Certain types of liver cancer, like fibrolamellar HCC, or severe bleeding problems would also exclude you. You also cannot be pregnant or breastfeeding, or on a liver transplant list. If you have certain autoimmune conditions or mental health issues that would make it difficult to lie still for treatment, you might not be able to participate.

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.

Are you 18 or older?
Do you have advanced liver cancer that can't be surgically removed?
Have you not had other drug treatments for your liver cancer yet?
Is your liver function generally good?
Are you a woman who is not pregnant or breastfeeding, and willing to use birth control?
Do you not have a pacemaker or large metal implants in your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the standard two immune-boosting medications as well as the special radiofrequency electromagnetic field treatment. The study doctors and nurses would carefully monitor your health and how you respond to the treatment. This would involve regular check-ups, blood tests, and scans to see how the cancer is reacting. You would also have an initial assessment to make sure you fit all the criteria for the study. The total duration of your participation would depend on how you respond to the treatment, but you would be monitored closely throughout. You would also need to be able to lie down comfortably for the radiofrequency treatments.

Potential risks and benefits

Potential benefits of joining this study could include access to a new combined treatment approach that might be more effective than current standard treatments for advanced liver cancer. However, as with any medical treatment, there are potential risks and side effects from both the immune medications and the radiofrequency treatment. These will be fully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Charité University Medicine Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is advanced liver cancer?

Advanced liver cancer means the cancer has grown within the liver or spread to other parts of the body, and it can't be fully removed with surgery or local treatments yet.

What are immune-boosting medications?

These are drugs that help your body's immune system recognise and fight cancer cells more effectively. In this study, two different types are being used together.

What is radiofrequency electromagnetic field treatment?

This treatment uses low-energy radio waves to create a field around the body. It’s different from traditional radiation therapy and is being explored as a way to help treat solid cancers.

Is this a new treatment?

The immune-boosting medications are already used, but combining them with this specific radiofrequency electromagnetic field treatment for advanced liver cancer is new and being tested in this study.

Where does this study take place?

This study is happening at Charité University Medicine in Berlin, Germany, as they have the specific equipment needed for the radiofrequency treatment.

How to find out more

Pirus Ghadjar, Prof. Dr.

pirus.ghadjar@charite.de +49 30 450 527318 Official trial record

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