Study on Fecal Microbiota Transfer with Vancomycin, Atezolizumab, and Bevacizumab for Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying treatments for liver cancer, specifically a type called hepatocellular carcinoma. The study will explore the effectiveness of a combination of treatments, including a medication called Vancomycin, a new treatment known as INTESTIFIX 001, and two cancer-fighting drugs, Atezolizumab and Bevacizumab. These treatments will be compared to their respective placebos to understand their impact on the disease.

The purpose of the study is to see how well these treatments work together in overcoming resistance to the cancer drugs Atezolizumab and Bevacizumab. Participants will receive these treatments over a period of time, and researchers will monitor the effects on the cancer, particularly looking at how the immune system responds. The study will also assess the safety of these treatments when used in combination.

Participants will be randomly assigned to receive either the actual treatments or the placebos. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure the results are unbiased. The trial will involve regular check-ups and monitoring to track the progress and any side effects experienced by the participants.

1 initial treatment phase

The trial begins with the administration of vancomycin in capsule form. This medication is taken orally. The purpose of this phase is to prepare the body for the subsequent treatments.

During this phase, the patient will also receive atezolizumab and bevacizumab through intravenous infusion. These medications are designed to target specific cancer cells and help the immune system fight the cancer.

2 treatment cycles

The treatment involves multiple cycles. Each cycle includes the administration of the medications mentioned in the initial phase.

The primary goal during these cycles is to assess the body’s response to the treatment, specifically looking at the infiltration of certain immune cells into the tumor.

3 monitoring and assessment

Throughout the trial, regular monitoring is conducted to evaluate the effectiveness of the treatment and to identify any side effects.

This includes imaging tests and biopsies to measure changes in the tumor and the presence of immune cells.

4 completion and follow-up

After completing the treatment cycles, there is a follow-up period to monitor the patient’s health and any long-term effects of the treatment.

The trial aims to conclude by July 2027, with ongoing assessments to ensure patient safety and gather comprehensive data on the treatment’s impact.

Who Can Join the Study?

Participants must be at least 18 years old at the time of screening.
For patients with active Hepatitis B Virus (HBV): The virus level must be less than 500 IU/ml, measured within 28 days before starting the study treatment. Patients must have been on anti-HBV treatment for at least 14 days before joining the study and be willing to continue treatment during the study.
For patients with active Hepatitis C Virus (HCV) infection: The infection must be managed according to local medical practice for the duration of the study.
Participants must have adequate organ and bone marrow function, measured within 72 hours before randomization, including:
- Hemoglobin level of at least 8 g/dL.
- Absolute neutrophil count of at least 1.0 x 10⁹/L.
- Platelet count of at least 50 x 10⁹/L.
- Total bilirubin level no more than 3 times the upper limit of normal.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 5 times the upper limit of normal.
- International normalized ratio (INR) no more than 1.6.
- Calculated creatinine clearance of at least 30 mL/min, determined by a specific formula.
Women who can become pregnant and men must use reliable contraception.
Women who can become pregnant must have a negative pregnancy test.
Participants must be able to understand the nature and consequences of the clinical trial and follow the study protocol and dosing schedule.
Participants must provide written informed consent before enrolling in the clinical trial.
Participants must be willing to undergo a tumor biopsy, which requires a tumor that can be accessed for a biopsy.
Participants must have confirmed Hepatocellular Carcinoma (HCC), either by imaging in a liver with cirrhosis or by a biopsy or surgery.
The disease must not be treatable by surgery, liver transplantation, or local therapies like curative ablation, trans-arterial chemoembolization (TACE), or trans-arterial radio-embolization (TARE).
Participants must be eligible for treatment with Atezolizumab and Bevacizumab according to standard medical care.
The disease must be measurable according to specific criteria called RECIST 1.1.
Participants must have preserved liver function with a Child-Pugh score of A or B, with a maximum of 7 points.
Participants must have a performance status of 0-1 on the ECOG scale, which measures daily living abilities.
An available CT scan of the chest and an MRI or CT scan of the abdomen with contrast, not older than 30 days before starting treatment, is required.
Participants must have documented hepatitis virus status, confirmed by screening tests for HBV and HCV.

Who Cannot Join the Study?

Patients with any other type of cancer besides hepatocellular carcinoma (a type of liver cancer) cannot participate.
Patients who have had a recent infection or illness that affects their immune system are not eligible.
Patients who are currently taking medications that might interfere with the study treatment are excluded.
Patients with severe liver or kidney problems that are not related to the cancer are not allowed to join.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with a history of allergic reactions to the study medications are excluded.
Patients who have a mental health condition that might affect their ability to follow the study procedures are not eligible.
Patients who have a history of substance abuse that could interfere with the study are not allowed to participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Urzsaionlrqqzsrmtfijn Espcr Atu	Essen	Germany
Usjqqudglnpkjnbbhildh Avzsfjtl	Augsburg	Germany
Uxwinsksjl Hmxxgomi Cocpjjs	Cologne	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.06.2025

Trial locations

Investigated drugs:

Vancomycin is an antibiotic used in this trial to help reduce certain bacteria in the gut. This is part of the treatment to see if it can improve the body’s immune response against liver cancer.

Atezolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in this trial to treat liver cancer by boosting the body’s natural defenses.

Bevacizumab is a medication that works by blocking the growth of blood vessels that supply nutrients to tumors. In this trial, it is used alongside other treatments to help control liver cancer.

INTESTIFIX 001 is a fecal microbiota transfer product used in this trial. It aims to change the gut bacteria to improve the effectiveness of cancer treatments and overcome resistance to other medications.

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis infection. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. The progression of the disease can lead to liver dysfunction and complications related to tumor growth. It is one of the most common types of liver cancer worldwide.

Trial ID:

2023-506887-15-00

Protocol code:

FLORA

NCT ID:

NCT05690048

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Fecal Microbiota Transfer with Vancomycin, Atezolizumab, and Bevacizumab for Patients with Advanced Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?