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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

23 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously and is currently used in the treatment of various cancers, including hepatocellular carcinoma. It is an approved medication in medical literature and is often studied in combination with other drugs to enhance its effectiveness. The main therapeutic indication for atezolizumab is to help the immune system attack cancer cells. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor.

  • Bevacizumab

    Bevacizumab is given through an intravenous infusion and is widely recognized in medical literature for its role in cancer treatment, particularly for hepatocellular carcinoma. It is used to inhibit the growth of blood vessels that supply nutrients to tumors, thereby slowing or stopping tumor growth. Bevacizumab works by targeting and inhibiting a protein called vascular endothelial growth factor (VEGF). It is classified as an angiogenesis inhibitor.

  • Vancomycin

    Vancomycin is typically administered orally or intravenously and is well-documented in medical literature as an antibiotic used to treat serious bacterial infections. In the context of clinical trials for liver cancer, it is being explored for its potential role in modifying gut microbiota to enhance cancer treatment efficacy. Vancomycin works by inhibiting bacterial cell wall synthesis, leading to the death of bacteria. It is classified as a glycopeptide antibiotic.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506887-15-00Protocol codeFLORAEstimated enrolment48 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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