RecruitingPHASE2INTERVENTIONAL

Atezolizumab/Bevacizumab Followed by On-demand TACE or Initial Synchronous Treatment With TACE and Atezolizumab/Bevacizumab

This research study is for people with a type of liver cancer called hepatocellular carcinoma (HCC) that doctors can't cure with surgery or other local treatments. They are testing two different treatment plans using a combination of two medicines, atezolizumab and bevacizumab, and a procedure called transarterial chemoembolization (TACE). One plan involves starting with the medicines and adding TACE if needed later. The other plan involves having TACE and the medicines at the same time from the start. The main goal is to find out which of these approaches works better for managing this type of liver cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Ludwig-Maximilians - University of Munich

Enrolment target

106

Start

10 Jun 2020

Estimated completion

01 Mar 2025

Hepatocellular Carcinoma Non-resectable

What is this study about?

This study is for people who have liver cancer, specifically a type called hepatocellular carcinoma (HCC), which doctors have decided cannot be completely removed by surgery or treated by other local procedures like burning or freezing the tumour. The aim is to investigate the best way to use a combination of treatments for this situation.

Researchers are comparing two different approaches. Both approaches use two medicines called atezolizumab and bevacizumab, which are given as injections. They also involve a procedure called transarterial chemoembolization (TACE). TACE is a way to deliver cancer-fighting drugs directly to the liver tumour while also blocking the blood supply to the tumour, helping to shrink it.

One group of patients in the study will start with the injections of atezolizumab and bevacizumab. If their doctors think it's needed later, they will then have the TACE procedure. The other group will have the TACE procedure and start the atezolizumab and bevacizumab injections at the same time. By comparing these two strategies, the researchers hope to learn which way of combining these treatments is most effective for people with this type of liver cancer.

Key takeaways

This study is for liver cancer (HCC) that can't be removed by surgery.
It tests two ways of combining special injections (atezolizumab/bevacizumab) and a procedure called TACE.
The goal is to find the most effective treatment approach.
Patients must be 18 or older and meet specific health criteria.
Participation involves regular hospital visits for treatment and check-ups.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be 18 years or older and have a confirmed diagnosis of hepatocellular carcinoma (liver cancer) that cannot be treated with surgery or other local methods, but is suitable for the TACE procedure. You should be generally well enough to take part, meaning you can look after yourself and have adequate organ function, as assessed by your doctor.

There are also some reasons why you might not be able to join. For example, if your cancer has spread widely, is too large, or if you have too many tumours. You would also not be eligible if you have significant fluid build-up in your belly or around your lungs, have certain heart conditions, or have had other cancer treatments for your liver cancer in the past.

Other reasons for not being able to join include having a history of certain autoimmune diseases, uncontrolled high blood pressure, or being on a liver transplant list. The doctor will carefully check all your health information to see if this study is suitable for you.

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 liver cancer (HCC) that doctors say can't be cured by surgery but could have TACE?
Are you generally well and able to look after yourself (ECOG 0 or 1)?
Have you NOT had other widespread (systemic) treatments for your liver cancer before?
Do you NOT have severe fluid build-up in your belly or chest?
Do you NOT have serious heart conditions or uncontrolled high blood pressure?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either injections of atezolizumab and bevacizumab first, with TACE added later if needed, or TACE and the injections at the same time. The specific schedule of visits and treatments will be explained in detail by the study team, but it will involve regular appointments for treatments and check-ups. These check-ups will include blood tests, scans, and other assessments to monitor your health and how the treatment is working.

Treatment will continue as long as it is working for you and you are tolerating it well. There will be a follow-up period after your active treatment ends to continue monitoring your health. The total duration of your participation in the study will depend on your individual response to treatment and the follow-up plan, but it could last for some time.

Potential risks and benefits

Participating in a clinical trial might offer potential benefits, such as receiving new treatments for your liver cancer that are not yet widely available. However, there are also potential risks involved, which could include side effects from the medicines (atezolizumab and bevacizumab) or complications from the TACE procedure. These risks will be fully explained to you before you decide to join. It is important to remember that you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

University of Bonn
Verified postcode
Bonn, Germany· Recruiting
University Hospital Cologne
Verified postcode
Cologne, Germany· Recruiting
Hospital of the University of Munich
Verified postcode
Munich, Germany· Recruiting
Klinikum Rechts der Isar of the Technical University Munich
Verified postcode
Munich, Germany· Recruiting
University Hospital Regensburg
Verified postcode
Regensburg, Germany· Recruiting
University Hospital Tübingen
Verified postcode
Tübingen, Germany· Recruiting
Würzburg University Hospital
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What is liver cancer?

Liver cancer, or hepatocellular carcinoma (HCC), is a type of cancer that starts in the liver cells.

What is TACE?

TACE stands for transarterial chemoembolization. It's a procedure where doctors deliver cancer drugs directly into the liver tumour and then block its blood supply.

What are atezolizumab and bevacizumab?

These are two medicines given by injection. Atezolizumab is an immunotherapy that helps your body’s immune system fight cancer, and bevacizumab helps stop blood vessels from growing to the tumour.

Will I know which treatment group I'm in?

The study aims to compare two different ways of giving the treatments. The study team will explain how this is managed, which might involve you not knowing your specific group right away.

Are these treatments new?

While individual parts of the treatment might be available, this study is looking at new ways to combine them for your specific cancer type. It's a Phase 2 trial, meaning it's still in relatively early stages of testing for this specific combination.

How to find out more

Enrico De Toni, MD

enrico.detoni@med.uni-muenchen.de +49 89 4400 0 Official trial record

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