Active not recruitingOBSERVATIONAL

Registry on Percutaneous Electrochemotherapy

This study, called RESPECT, is looking at a treatment for primary and secondary liver cancer. The treatment, called electrochemotherapy (ECT), uses a special device called CLINIPORATOR. ECT works by making cancer cells more open to medicines, helping them to work better. This study specifically looks at a way of giving ECT where the treatment is put directly into the liver through the skin, rather than through surgery. The aim is to see how well this method works, if it's safe, and if it leads to a faster recovery for a larger number of patients across different hospitals. The researchers also want to collect more information over time about how people do after this treatment.

At a glance

Status

Active not recruiting

Sponsor

Cardiovascular and Interventional Radiological Society of Europe

Enrolment target

250

Start

25 Jan 2023

Estimated completion

31 Jan 2027

Primary Liver Cancer Secondary Liver Cancer

What is this study about?

This study is called RESPECT, which stands for Registry on Percutaneous Electrochemotherapy. It's looking at a way to treat liver cancer, both cancer that starts in the liver (primary) and cancer that has spread to the liver from somewhere else (secondary). The treatment is called electrochemotherapy, or ECT. It uses a special device called CLINIPORATOR to deliver gentle electrical pulses to the liver.

The idea behind ECT is to make cancer cells more receptive to certain anti-cancer medicines. These electrical pulses temporarily open up tiny holes in the cancer cells, allowing more medicine to get inside and kill them. This method is designed to mostly affect the cancer cells, causing less harm to healthy parts of the liver. Giving this treatment through the skin (percutaneous) means it's less invasive than traditional surgery, which could lead to quicker recovery and shorter stays in hospital.

While ECT has been used before, this study wants to gather more information about how effective and safe this "through-the-skin" approach is when used for liver cancer in many different patients and hospitals. The researchers want to understand how well it works for a larger group of people and to follow up with patients over time to see the long-term effects. This will help doctors decide if this treatment is a good option for more people with liver cancer.

Key takeaways

Study looks at a liver cancer treatment called electrochemotherapy (ECT).
ECT uses electrical pulses to help medicines kill cancer cells.
This study focuses on giving ECT through the skin, not surgery.
Researchers want to see how safe and effective this method is for many patients.
It aims to provide more data on recovery and long-term results.
Participation involves receiving the planned pECT treatment and being observed.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with either primary or secondary liver cancer. Importantly, your doctors must have decided that this specific treatment, called percutaneous electrochemotherapy (pECT) using the CLINIPORATOR device, is the right treatment plan for you, based on discussions within a team of specialists.

Before you can take part, you'll also need to sign a consent form, which means you understand what the study involves and agree to participate. You won't be able to join if you are pregnant.

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 old or older?
Do you have primary or secondary liver cancer?
Has your doctor's team decided that percutaneous electrochemotherapy (pECT) with CLINIPORATOR is your treatment plan?
Are you able to sign a form to say you understand and agree to take part?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the percutaneous electrochemotherapy (pECT) treatment for your liver cancer using the CLINIPORATOR device, as planned by your medical team. This is a non-randomised study, meaning you won't be put into different groups by chance. Instead, you'll be receiving this specific treatment as part of your care.

The study is observational, which means researchers will be carefully watching and recording information about your treatment and how you respond. This includes details about the procedure itself, any side effects you might experience, and how your cancer responds over time. They will also collect follow-up information after your treatment. The total duration of your participation will depend on the standard follow-up schedule for this type of treatment.

Potential risks and benefits

Taking part in this study means you'll receive a specific treatment for liver cancer (percutaneous ECT) that your doctors have already decided is suitable for you. Potential benefits include receiving a minimally invasive treatment that may lead to a faster recovery and shorter hospital stay compared to more extensive surgery. However, as with any medical procedure, there are potential risks, which your doctor will discuss with you in detail. These can include pain, bleeding, infection, or other complications related to the procedure. It's important to remember that you are free to withdraw from the study at any time without affecting your medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Centre Hospitalier Universitaire de Montpellier
Verified postcode
Montpellier, France
Hôpital Européen Georges-Pompidou
Verified postcode
Paris, France
Institut Gustave Roussy
Verified postcode
Paris, France
WEGE Klinik
Verified postcode
Bonn, Germany
Städtisches Klinikum Braunschweig
Verified postcode
Braunschweig, Germany
Universitätsklinikum Halle
Verified postcode
Halle, Germany
Helios Park-Klinikum
Verified postcode
Leipzig, Germany
University Hospital Regensburg
Verified postcode
Regensburg, Germany
University of Szeged
Verified postcode
Szeged, Hungary
Istituto Europeo di Oncologia
Verified postcode
Milan, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Verified postcode
Rome, Italy
Policlinico Universitario A. Gemelli
Verified postcode
Rome, Italy

Common questions

What is electrochemotherapy (ECT)?

It's a treatment that uses gentle electric pulses to help anti-cancer medicines work better inside cancer cells, especially in the liver.

What is the CLINIPORATOR?

It's a special device that delivers the electrical pulses for the electrochemotherapy treatment.

What does 'percutaneous' mean?

It means the treatment is given through the skin, usually by inserting a needle, rather than through a large surgery. This is less invasive.

Is this treatment new?

Electrochemotherapy has been used before, but this study is specifically looking at how well the 'through-the-skin' approach works for liver cancer in a larger group of people.

Who is funding this study?

The information provided does not specify the funding body for this particular study, but the CLINIPORATOR device's development was supported by the European Commission.