Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Fecal Microbiota Transplant (FMT) combined with Atezolizumab plus Bevacizumab in Patients with HepatoCellular Carcinoma who failed to respond to prior Immunotherapy – the FAB-HCC pilot study

This research study is for people with a type of liver cancer called hepatocellular carcinoma, specifically when their cancer hasn't responded well to earlier treatments that use the body's immune system. The main goal is to test a new combination treatment. This involves two existing cancer drugs, Avastin and Tecentriq, which are given as infusions, along with something new called a Fecal Microbiota Transplant (FMT). FMT aims to change the helpful bacteria in a person's gut. Researchers want to see if this combination causes any side effects and how severe they are. They also want to understand if it helps to control the cancer or shrink it. This is a Phase II study, meaning it's exploring whether the treatment works and is safe in a small group of people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medical University Of Vienna

Enrolment target

Start

10 Dec 2024

Hepatocellular Carcinoma

What is this study about?

This study is looking into a new approach for treating a type of liver cancer known as hepatocellular carcinoma. Sometimes, when people have this cancer, their bodies don't respond as well as hoped to treatments that boost their immune system to fight the cancer. This study is for those particular patients.

The research combines two medicines that are already used for cancer treatment: Avastin and Tecentriq. These are given through a drip into a vein. What's new and different about this study is that these medicines are given alongside something called a Fecal Microbiota Transplant (FMT). FMT involves introducing healthy bacteria from a donor's gut into the patient's gut, usually as a capsule or liquid. The idea behind FMT in this study is that a healthier collection of gut bacteria might help the body respond better to the cancer medicines.

This is a pilot study, which means it's one of the first steps to see if this combined treatment is safe and if it shows promise for treating liver cancer. Researchers will carefully watch for any side effects and how severe they are. They will also check if the treatment helps to stop the cancer from growing, shrink it, or even make it disappear. This will help them decide if larger studies are needed in the future.

Key takeaways

New combination treatment for liver cancer (hepatocellular carcinoma).
Aims to help patients who didn't respond to previous immune treatments.
Combines existing drugs (Avastin, Tecentriq) with Fecal Microbiota Transplant (FMT).
Focuses on checking safety and how well it controls the cancer.
Participation includes regular hospital visits and health monitoring.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old – there's no upper age limit.

Doctors will also check other things like your overall health and the specific details of your liver cancer, especially whether previous immune-boosting treatments haven't worked for you. Both men and women can take part.

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 hepatocellular carcinoma (a type of liver cancer)?
Has your cancer not responded well to immune-boosting treatments before?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study treatments, which include infusions of Avastin and Tecentriq, along with the Fecal Microbiota Transplant (FMT). You'll have regular hospital visits for these treatments and to have check-ups. During these visits, doctors and nurses will monitor your health, ask about any side effects you might be experiencing, and perform tests like blood tests and scans.

The study team will carefully track your progress and how you're feeling throughout the treatment period. You'll also likely be asked to fill out questionnaires about your quality of life, which helps researchers understand how the treatment affects your daily living. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will have follow-up appointments even after treatment ends.

Potential risks and benefits

Taking part in this study might offer a potential benefit by giving you access to a new combination treatment for your liver cancer, which could help where previous treatments haven't. However, like all medical treatments, there are potential risks, including side effects from the medicines (Avastin and Tecentriq) and from the Fecal Microbiota Transplant (FMT). The research team will closely monitor you to identify and manage any side effects. 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
Austria

Common questions

What is Fecal Microbiota Transplant (FMT)?

FMT involves taking healthy bacteria from a donor's gut and giving them to a patient, usually as a capsule or liquid, to improve their gut health.

What kind of cancer is this study for?

This study is for a specific type of liver cancer called hepatocellular carcinoma.

Why are they combining these treatments?

Researchers believe that improving gut bacteria with FMT might help the body respond better to the cancer medicines Avastin and Tecentriq.

Will I get 'new' medicines?

Avastin and Tecentriq are already approved medicines. FMT is being explored as part of this new combination.

What's a 'Phase II' study?

A Phase II study is an early stage of clinical research that looks to see if a new treatment is effective and safe in a small group of people.