RecruitingNAINTERVENTIONAL

Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer

This study is exploring a new treatment approach for people with bowel cancer that has spread to the liver and hasn't gotten better with standard chemotherapy. It combines a treatment called radiofrequency electromagnetic field therapy with two chemotherapy drugs, TAS-102 (Lonsurf) and Bevacizumab. Researchers want to see if this combination is safe and effective when standard treatments are no longer working. The study is a first step to understand how well these treatments work together. If you've had at least two different chemotherapy treatments for your bowel cancer and it's mostly in your liver, you might be able to take part. The aim is to find better ways to help people living with this type of cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

15 Dec 2023

Estimated completion

01 Nov 2026

Refractory Metastatic Colorectal Cancer

What is this study about?

This research study is investigating a new way to treat bowel (colorectal) cancer that has spread to the liver and hasn't responded to earlier treatments. When cancer spreads, it's called metastatic cancer. This specific study is for people whose cancer is mainly in their liver and hasn't been controlled by at least two different types of chemotherapy they've already received.

The study combines two existing cancer medicines, TAS-102 (also known as Lonsurf) and Bevacizumab, with a special treatment called radiofrequency electromagnetic field therapy. This therapy uses a mild electrical field. While we know that this electrical field treatment can be safe for different parts of the body, including the tummy area, doctors don't yet know how it works when given alongside TAS-102 and Bevacizumab. This study aims to find out if this combination treatment is safe and practical to use.

The main goal of this particular study is to see if this new combined treatment can be used successfully in people. It's a 'feasibility' study, meaning it's an initial step to see if the treatment can be given safely without causing too many problems. The results will then be compared with information from similar patients who received different treatments. This helps researchers understand whether combining these treatments could be a promising new approach for people whose cancer hasn't responded to other options.

Key takeaways

This study is for advanced bowel cancer that has spread to the liver and hasn't responded to previous treatments.
It combines three treatments: two existing cancer drugs (TAS-102 and Bevacizumab) and a special electrical field therapy.
The main goal is to see if this combined treatment is safe and practical to use.
It's a 'feasibility' study, an early step in researching this new approach.
You must have completed at least two prior chemotherapy regimens.

Who may be eligible?

To join this study, you need to be at least 18 years old and have bowel cancer that has spread to your liver. This means your cancer must be mostly in your liver, and you will have already tried at least two different chemotherapy treatments for it that haven't worked well or are no longer suitable for you. Your general health should be good enough to take part, meaning you can mostly look after yourself.

You'll also need to have certain blood test results within a healthy range, showing your bone marrow, liver, and kidney functions are working properly. Your cancer type will also need to have specific genetic information known (your KRAS status). You must be able to take medicines by mouth, and if you're a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control.

There are also reasons why you might not be able to join. For example, if your cancer has spread significantly to other parts of your body besides the liver, or if you've already been treated with TAS-102 before. You also couldn't take part if you have other serious illnesses, some types of infections, or certain serious conditions like active brain metastases or fluid build-up around your lungs or stomach that needs draining.

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 years or older?
Do you have bowel cancer that has spread, mostly to your liver?
Have you already had at least two different chemotherapy treatments for your cancer that didn't work well or aren't suitable now?
Is your general health good enough for you to look after yourself (ECOG 0 or 1)?
Are your latest blood tests for your liver, kidneys, and blood cells within a healthy range?
Do you know your cancer's 'KRAS status'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital. These visits will involve various tests, such as blood tests, to monitor your health and how your body is responding to the treatment. You will receive the combination of TAS-102, Bevacizumab, and the radiofrequency electromagnetic field treatment. TAS-102 is usually given as a tablet you take by mouth, while Bevacizumab is given as an infusion into a vein. The radiofrequency electromagnetic field treatment is a separate procedure. The duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve ongoing assessments and follow-up care for as long as you are receiving the study treatment.

Potential risks and benefits

Participating in a clinical trial like this offers the potential benefit of accessing new treatments that are not yet widely available, which might help control your cancer where standard therapies haven't. However, as this is a new combination, there are potential risks, including side effects from the medicines (like changes in blood count or other known side effects of TAS-102 and Bevacizumab) and from the electromagnetic field treatment, which are being carefully monitored. Everyone reacts differently, and some side effects could be serious. You will be closely monitored by the study team, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is 'refractory' metastatic colorectal cancer?

This means your bowel cancer has spread to other parts of your body (metastatic), and it hasn't responded well to at least two previous standard chemotherapy treatments.

What is radiofrequency electromagnetic field treatment?

It's a treatment that uses a mild electrical field, similar to radio waves, applied to the body. In this study, it's being explored alongside medicines.

What are TAS-102 (Lonsurf) and Bevacizumab?

These are both medicines already used to treat various cancers. They work in different ways to slow down cancer growth or cut off its blood supply.

Why is this study only for people with cancer mainly in their liver?

This particular study focuses on liver-dominant cancer to better understand how the combined treatment works in a specific situation, as the electrical field treatment is applied to the abdomen area.

Is this a new medicine that isn't approved yet?

TAS-102 and Bevacizumab are approved medicines. The new part is combining them with the radiofrequency electromagnetic field treatment, which makes this a new treatment approach being studied.

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.