RecruitingPHASE2INTERVENTIONAL

Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma

This study is investigating a new way to treat advanced liver cancer, also known as hepatocellular carcinoma (HCC). For some people with HCC, standard immunotherapy treatments don't work as well as hoped, or their cancer starts to grow again. Researchers are exploring if adding a specific type of friendly bacteria, called EXL01, could make these immunotherapies more effective. This bacteria is similar to one naturally found in our gut and has shown promising results in other cancer types. The aim is to see if EXL01 can help overcome resistance to immunotherapy in patients whose HCC hasn't responded to their first-line treatment, potentially improving their results.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Center Eugene Marquis

Enrolment target

Start

12 Mar 2025

Estimated completion

12 Dec 2026

Hepatocellular Carcinoma

What is this study about?

Hepatocellular carcinoma (HCC) is the most common type of liver cancer that starts in the liver. While there have been good advancements in treatment, especially with immunotherapy, sometimes these treatments don't work for everyone, or their effects don't last. About a third of patients respond well to immunotherapy, but for others, the cancer might not shrink, or it might even continue to grow.

Our bodies are home to trillions of tiny living organisms, like bacteria, especially in our gut. This collection of organisms is called the 'microbiota'. Recently, scientists have found that certain types of gut bacteria might play a role in how well cancer treatments work. One particular bacteria, called Faecalibacterium prausnitzii, is quite common in healthy guts. Studies in other cancers, like melanoma (a type of skin cancer), have hinted that people with more of this bacteria in their gut before treatment might respond better to immunotherapy.

This study is testing a special preparation of this beneficial bacteria, called EXL01. We want to see if adding EXL01 to the standard immunotherapy drugs currently used for advanced HCC can help patients whose cancer hasn't responded well to their initial immunotherapy. The idea is that by improving the gut bacteria balance, we might help the body's immune system fight the cancer more effectively and reverse the resistance to the immunotherapy treatment.

Key takeaways

This study evaluates adding beneficial gut bacteria (EXL01) to standard immunotherapy for advanced liver cancer.
It aims to improve treatment effectiveness for patients whose cancer hasn't responded well to initial immunotherapy.
EXL01 contains a bacteria similar to one naturally found in our gut.
Participation involves continuing current immunotherapy plus taking EXL01, with regular check-ups.
This is a Phase 2 trial, meaning it's an early-stage study to check safety and effectiveness.

Who may be eligible?

This study is looking for both men and women aged 18 or older who have been diagnosed with advanced liver cancer (hepatocellular carcinoma). Importantly, your cancer must have started to grow again after you've already received a standard first-line immunotherapy treatment.

To be considered, your medical team must agree that continuing with the same immunotherapy treatment is a suitable option for you. You'll also need to be generally stable, with good liver function (Child-Pugh A score) and a good overall physical condition (ECOG performance status 0 to 1). There are also specific requirements for your blood tests and kidney function.

There are several reasons why someone might not be able to join. For example, if your prior immunotherapy treatment worked well, or if you had severe side effects from it, you would not be eligible. Also, if more than half of your liver is affected by cancer, or if you have certain other serious health conditions like ongoing severe autoimmune disease, HIV, or uncontrolled chronic hepatitis B, you wouldn't be able to participate. Pregnant or breastfeeding women, or those planning to become pregnant without using effective contraception, also cannot join the study.

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 advanced liver cancer (HCC) that has started to grow again after first-line immunotherapy?
Has your doctor agreed that continuing your current immunotherapy is an option for you?
Do you have generally good health, good liver function, and normal blood test results?
Are you able to swallow medication easily?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive your current standard immunotherapy treatment. In addition to this, you will be given the study treatment, EXL01, which is a special preparation of beneficial bacteria. The specifics of how often you will take EXL01 and for how long will be explained by the study team.

Throughout the study, you will have regular visits to the clinic. These visits will involve blood tests, physical examinations, and scans (like CT or MRI) to check how well the treatment is working and to monitor your general health. You will be asked about any side effects or changes you notice in your health. The total duration of your participation in the study will depend on your response to treatment and will be discussed fully with you by the study doctor.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as helping your current immunotherapy treatment work better against your liver cancer. However, there's no guarantee that you will personally benefit. While the EXL01 bacteria is similar to one found naturally in the gut, there could be potential risks or side effects from taking it, or from continuing your immunotherapy. The study team will explain all known side effects and monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

hôpital Avicenne
Verified postcode
Bobigny, France· Active not recruiting
CHU de Bordeaux
Verified postcode
Bordeaux, France· Active not recruiting
Hôpital Beaujon
Verified postcode
Clichy, France· Recruiting
CHU de Nantes Hotel Dieu
Verified postcode
Nantes, France· Active not recruiting
Centre de luttre contre le cancer Eugène Marquis
Verified postcode
Rennes, France· Recruiting
Gustave ROUSSY
Verified postcode
Villejuif, France· Active not recruiting

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight cancer cells.

What is EXL01?

EXL01 is a special preparation containing a type of friendly bacteria called Faecalibacterium prausnitzii, which is found naturally in our gut.

Why are you looking at gut bacteria?

Research suggests that certain gut bacteria might influence how well cancer treatments like immunotherapy work.

Will I stop my current cancer treatment?

No, you will continue your current standard immunotherapy treatment. EXL01 will be given in addition to it.

What are the main tests in the study?

You'll have regular blood tests, physical exams, and scans to monitor your health and how the treatment is working.

How to find out more

Valérie JOLAINE

v.jolaine@rennes.unicancer.fr 0299253036 Official trial record

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