RecruitingPHASE2INTERVENTIONAL

Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)

This study, called FLORA, is for people in the UK with advanced liver cancer that can't be removed by surgery. We're testing a new approach that combines faecal microbiota transplant (FMT) – which involves introducing healthy gut bacteria – with a standard immunotherapy treatment (Atezolizumab/Bevacizumab). We want to find out if FMT can make the immunotherapy more effective by helping it overcome any resistance. Participants will be randomly assigned to either receive the FMT alongside their usual treatment or a placebo (dummy) treatment. This will help us understand if FMT is safe and if it helps people with liver cancer to respond better to their medication.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Michael Dill

Enrolment target

Start

16 Jul 2025

Estimated completion

01 Mar 2028

Immunotherapy HCC - Hepatocellular Carcinoma

What is this study about?

This study, called FLORA, is designed to help us understand how to make existing treatments for a type of liver cancer, called hepatocellular carcinoma (HCC), work even better. HCC is a serious condition, and while we have treatments like a combination of drugs called Atezolizumab and Bevacizumab, sometimes the cancer can become resistant to these. This study explores if a treatment called faecal microbiota transplant, or FMT, can help overcome this resistance.

FMT involves taking healthy gut bacteria from a donor and giving it to someone else. The idea is that improving the balance of bacteria in a patient's gut might boost their immune system and help the cancer drugs work more effectively. We hope this could lead to better outcomes for people with advanced liver cancer.

Participants in this study will be randomly put into one of two groups. One group will receive the FMT alongside their standard Atezolizumab and Bevacizumab treatment, and the other group will receive a placebo (a dummy treatment that looks like the real thing but has no active ingredients). This method helps us compare the two groups fairly and find out if FMT truly makes a difference. The study is "double-blind," which means neither you nor your doctors will know which group you are in.

Key takeaways

This study combines a gut bacteria treatment (FMT) with standard liver cancer immunotherapy.
It aims to see if FMT can help immunotherapy work better against advanced liver cancer.
Participants will be randomly assigned to receive either FMT or a dummy treatment alongside their standard care.
The study measures safety and how well the treatment works.
You will be closely monitored, and procedures like colon checks and biopsies are part of the process.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of liver cancer (specifically hepatocellular carcinoma) that doctors can't treat with surgery, a liver transplant, or other local treatments.

You also need to be suitable for the standard Atezolizumab and Bevacizumab treatment. Your liver function needs to be generally good, and you should be able to get around and look after yourself without too much difficulty.

You wouldn't be able to join if you've recently taken medicines that suppress your immune system, or if you've had certain other conditions like some autoimmune diseases, HIV, or an active Hepatitis B or C infection. Also, if you've had certain previous cancer treatments or serious gastrointestinal problems, this study might not be 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.

Am I 18 years old or older?
Do I have liver cancer (HCC) that can't be treated with surgery or a transplant?
Am I suitable for the standard Atezolizumab/Bevacizumab treatment?
Do I have generally good liver function and can I manage most daily activities?
Have I avoided certain immune-suppressing drugs or probiotics recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some tests to make sure the study is right for you. You'll then be randomly assigned to one of two groups: either receiving FMT or a placebo, alongside your standard Atezolizumab and Bevacizumab treatment. Before the main treatment starts, you’ll have a procedure called a sigmoidoscopy to look at part of your bowel, and you’ll also take a medication (or a placebo) for a few days.

Your standard Atezolizumab and Bevacizumab treatment will be given every 21 days. On the first and second cycles of this treatment, you'll also receive the FMT or placebo, which will be given as capsules you swallow. Around 6 weeks after starting, you'll have another sigmoidoscopy and a tumour biopsy (a small sample taken from your cancer). Regular checks, including scans, will be done to see how you are responding and if the treatment is safe for you. The total duration of your involvement will depend on how you respond to the treatment and the study plan.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that aren't yet widely available, and you'll be closely monitored by a dedicated medical team. There's a potential that the FMT could help your immunotherapy work better, but this isn't guaranteed. As with any medical treatment, there are potential risks, including side effects from the medications or procedures like sigmoidoscopy or biopsy. You will be told about all the known risks before you decide to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (7)

University Hospital Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
University Hospital Augsburg
Verified postcode
Augsburg, Germany· Not yet recruiting
University Hospital Essen
Verified postcode
Essen, Germany· Not yet recruiting
University Hospital Mannheim
Verified postcode
Mannheim, Germany· Not yet recruiting
University Hospital Regensburg
Verified postcode
Regensburg, Germany· Not yet recruiting
University Hospital Tübingen
Verified postcode
Tübingen, Germany· Not yet recruiting
University Hospital Ulm
Verified postcode
Ulm, Germany· Not yet recruiting

Common questions

What is 'Fecal Microbiota Transfer' (FMT)?

FMT involves giving you healthy gut bacteria, usually from a carefully screened donor, to improve the balance of microbes in your gut. In this study, it's given as capsules.

What is 'Atezolizumab/Bevacizumab'?

These are two medicines given together as a standard immunotherapy treatment for liver cancer. They work by helping your body's immune system fight the cancer and by reducing the blood supply to the tumour.

What does 'double-blind' mean?

It means neither you nor your doctors will know if you're receiving the active FMT treatment or a placebo (dummy treatment). This helps ensure the study results are fair and unbiased.

Will I still receive my normal cancer treatment?

Yes, all participants in this study will receive the standard Atezolizumab/Bevacizumab treatment. The FMT or placebo is given in addition to this standard care.

What is a sigmoidoscopy?

A sigmoidoscopy is a procedure where a thin, flexible tube with a camera is used to look at the lower part of your bowel (your sigmoid colon).

How to find out more

Michael T Dill, PhD

michael.dill@med.uni-heidelberg.de 06221 568611 Official trial record

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