Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Ezurpimtrostat autophagy inhibitor in association with Atezolizumab-Bevacizumab in first line treatment of unresectable hepatocellular carcinoma, a phase 2b randomized trial. ABE-LIVER

This study, called ABE-LIVER, is looking into a new treatment approach for a type of liver cancer (hepatocellular carcinoma) that has spread or can't be surgically removed. It combines a new drug, Ezurpimtrostat, with two existing medications, Atezolizumab and Bevacizumab. Researchers want to find out how effective this new combination is at stopping the cancer from growing or spreading. They'll also check how long people live, if their tumours shrink, and improvements in their quality of life. The study also aims to understand the safety of this new drug combination. This is a Phase 2b study, meaning it's exploring how well the treatment works and looking at its safety more closely.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Grenoble

Enrolment target

196

Start

30 Nov 2022

unresectable hepatocellular carcinoma

What is this study about?

This study is called ABE-LIVER, and it's looking into new ways to treat liver cancer, specifically a type called hepatocellular carcinoma. This is for people whose cancer is advanced and can't be removed with surgery. The doctors are testing a new medicine called Ezurpimtrostat alongside two other standard drugs, Atezolizumab and Bevacizumab, which are already used to treat this type of cancer.

The main goal of the study is to see how well this new combination of treatments works. They want to find out how long the cancer stays stable without growing or spreading further. This is called 'progression-free survival'. They will also be looking at other important things, like if the tumours shrink, how long people live, and how the treatment affects their general well-being and quality of life.

This is a Phase 2b study, which means it builds on earlier research. In this phase, doctors are trying to understand more about the treatment's safety and how effective it is in a larger group of people. The information gathered will help decide if this new treatment combination should be studied further in even larger trials.

Key takeaways

This study tests a new drug, Ezurpimtrostat, with standard treatments for advanced liver cancer.
It aims to see how well the treatment stops cancer growth and improves life expectancy.
The study also monitors safety and quality of life.
Participants must have liver cancer that cannot be surgically removed.
It's a Phase 2b trial, focusing on treatment effectiveness and safety.

Who may be eligible?

To join this study, people need to be at least 18 years old. There's no upper age limit, so older adults can also take part if they meet other criteria.

Since this study is for a specific type of liver cancer, participants must have hepatocellular carcinoma that cannot be removed by surgery. This means the cancer is advanced or has spread.

Doctors will also run other tests to make sure that the treatment is suitable and safe for each person. These tests check overall health, specific cancer features, and whether other medical conditions would prevent participation.

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?
Have you been diagnosed with liver cancer (hepatocellular carcinoma)?
Has your doctor told you your liver cancer cannot be removed by surgery?
Are you willing to have regular hospital visits, blood tests, and scans?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would be randomly assigned to receive either the new drug combination or a standard treatment. This means neither you nor your doctor would choose which treatment you get. You would receive the study medications, which are given through an infusion (into a vein). You would have regular visits to the hospital or clinic for these infusions, as well as for blood tests, scans (like CT or MRI), and check-ups to monitor your health and how the treatment is working. Doctors will carefully track any side effects you might experience. These visits will continue for a set period, and after the treatment phase, there will be follow-up appointments to monitor your long-term health. The exact number and frequency of visits will be explained in detail.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring by a medical team. However, there are also potential risks, including side effects from the medications, which can vary from person to person. The new drug combination might not work for everyone, or it could potentially be less effective than existing treatments. You would be fully informed about all known risks and benefits before deciding to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 'unresectable hepatocellular carcinoma'?

It's a type of liver cancer that can't be surgically removed, usually because of its size, location, or if it has spread.

What does a 'Phase 2b trial' mean?

It means the study is in a middle stage, exploring how well a treatment works and looking more closely at its safety in a group of people.

What does 'Progression-Free Survival' (PFS) mean?

It's how long a person lives with the cancer not getting worse or spreading, or before they pass away, whichever happens first.

Are Atezolizumab and Bevacizumab new drugs?

No, these are existing treatments often used for this type of liver cancer. This study is testing a new drug along with them.

Will I know which treatment I'm getting?

In this type of study, you'll be randomly assigned to a treatment group, and often neither you nor your doctors will know which specific treatment you are receiving until the study is over.