Active not recruitingPHASE3INTERVENTIONAL

A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

This research is investigating new treatment options for a type of liver cancer that cannot be removed by surgery and has grown or spread, even after previous treatment. Specifically, it's a 'Phase 3' study, which means it's testing potential treatments that have shown promise in earlier stages, comparing them against existing care. Doctors want to see if combining the drug atezolizumab with either lenvatinib or sorafenib is more effective and safe than using lenvatinib or sorafenib on their own. Participants are assigned randomly into groups, and everyone knows which treatment they are receiving. The goal is to find better ways to help people with advanced liver cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

557

Start

26 Apr 2021

Estimated completion

30 Jun 2026

Unresectable Hepatocellular Carcinoma

What is this study about?

This study is for people who have liver cancer that doctors can't remove with surgery, and where the cancer has grown or spread despite already having treatment with a combination of two drugs called atezolizumab and bevacizumab. The main goal is to find out if adding atezolizumab to lenvatinib or sorafenib is a better treatment option than just using lenvatinib or sorafenib by themselves.

Doctors are particularly interested in seeing if these new combinations can slow down the cancer's growth for longer, or shrink it more effectively, while also making sure they are safe to use. This is a 'Phase 3' study, which is the final stage before a new treatment might become widely available. It's designed to confirm how well a treatment works and its safety in a larger group of people.

All participants will be put into one of two groups by chance (like flipping a coin). One group will receive atezolizumab combined with either lenvatinib or sorafenib. The other group will receive just lenvatinib or sorafenib on their own. This helps doctors fairly compare the effects of the different treatments. The results from this study could help improve future care for people with this type of liver cancer.

Key takeaways

This study is for advanced liver cancer that has previously been treated, but is still progressing.
It aims to find better treatments by combining existing drugs.
Participation involves regular hospital visits for treatment and check-ups.
You will know which treatment group you are in.
You can leave the study at any time.
The goal is to improve future care for people with liver cancer.

Who may be eligible?

To join this study, you would need to have liver cancer that has spread or can't be removed by surgery. Your doctors would have already confirmed this diagnosis. Importantly, your cancer must have continued to grow or spread even after you've had treatment with two specific drugs: atezolizumab and bevacizumab. They would also check that you are generally well enough to take part, with healthy organ function and able to get around.

There are also some important reasons why you might not be able to join. For example, if your cancer has spread to your brain and is causing symptoms, or if you've had a certain type of severe liver problem in the past six months. Also, if you have a different type of cancer, or a specific rare form of liver cancer, you might not be eligible.

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.

Do you have liver cancer that doctors can't remove with surgery?
Has your liver cancer been treated before with atezolizumab and bevacizumab, but is still growing?
Are you generally well and able to perform your daily activities without much difficulty?
Do you have good overall health, including how your liver, kidneys, and blood are working?
Have you recently had a certain type of severe liver problem or cancer spread to your brain that is causing symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of two treatment groups. You'll know which treatment combination you're getting. You'll regularly visit the hospital for your treatment doses, usually given over a period of time, and to have various tests. These tests include blood samples, scans (like CT or MRI) to check on your cancer, and check-ups with the doctor to see how you're feeling and to monitor for any side effects. These visits will continue as long as the treatment is helping and you are tolerating it well. After you stop treatment, you'll continue to have follow-up check-ups for a certain period to monitor your health.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which might be more effective in controlling your cancer than standard options. However, as with any medical treatment, there are potential risks and side effects from the drugs being tested, which your doctor will discuss in detail. You will be closely monitored for any unwanted effects. It's very important to remember that participating in this study is completely your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (123)

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

Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria
Uniklinikum Salzburg, LKH
Verified postcode
Salzburg, Austria
Universitätsklinikum St. Pölten
Verified postcode
Sankt Pölten, Austria
Klinik Favoriten
Verified postcode
Vienna, Austria
AZ KLINA
Verified postcode
Brasschaat, Belgium
Cliniques Universitaires St-Luc
Verified postcode
Brussels, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
AZ Delta (Campus Rumbeke)
Verified postcode
Roeselare, Belgium
Hospital Felicio Rocho
Verified postcode
Belo Horizonte, Brazil
Hospital Moinhos de Vento
Verified postcode
Porto Alegre, Brazil
Hospital Sao Lucas - PUCRS
Verified postcode
Porto Alegre, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Verified postcode
Florianópolis, Brazil

Common questions

What is 'unresectable' liver cancer?

This means your liver cancer cannot be removed by surgery, usually because of its size, location, or if it has spread.

Why is this a 'Phase 3' study?

Phase 3 means this is a larger study to confirm if a new treatment is effective and safe compared to current treatments, before it can be made widely available.

Will I know which treatment I am getting?

Yes, this is an 'open-label' study, meaning both you and your doctors will know which treatment you are receiving.

What happens if I decide to stop participating?

You can withdraw from the study at any time without needing to give a reason, and it won't affect your future medical care.

What are atezolizumab, lenvatinib, and sorafenib?

These are different types of medicines used to treat cancer. Atezolizumab helps your immune system fight cancer, while lenvatinib and sorafenib are drugs that target specific pathways to slow cancer growth.