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Study on Fecal Microbiota Transplant with Atezolizumab and Bevacizumab for Liver Cancer Patients Unresponsive to Previous Immunotherapy

Verified siteRegistered drugNo placebo

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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 a type of liver cancer known as Hepatocellular Carcinoma (HCC). The study is exploring a new treatment approach for patients whose cancer has not responded to previous treatments. The treatment being tested combines a procedure called Fecal Microbiota Transplant (FMT) with two medications: Atezolizumab and Bevacizumab. Atezolizumab, also known by its code name RO5541267, and Bevacizumab are both given as solutions through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the safety of this combined treatment by monitoring any side effects that may occur. Participants in the study will receive the treatment and be closely observed by medical professionals. The study will track how patients respond to the treatment over time, including any changes in their cancer and overall health. The study aims to provide valuable information on whether this combination of treatments can help patients with HCC who have not had success with other therapies.

Throughout the study, participants will undergo regular check-ups and assessments to ensure their well-being and to gather data on the treatment's effects. The study will continue until enough information is collected to understand the safety and potential benefits of this new treatment approach. This research is an important step in finding more effective ways to treat liver cancer and improve outcomes for patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet the study's eligibility criteria. This includes checking your blood and organ function, as well as confirming your medical history and current health status.
Step 3
Treatment administration
You will receive two medications: Avastin and Tecentriq. Both are given as a solution for infusion, which means they are administered directly into your bloodstream through a vein.
Avastin is provided at a concentration of 25 mg/ml, and Tecentriq is provided at a dosage of 1,200 mg. The frequency and duration of these infusions will be determined by the study protocol and your healthcare provider.
Step 4
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular check-ups to assess the safety and effectiveness of the treatment.
You will be asked to report any side effects or changes in your health. The severity of any side effects will be evaluated using a standardized system.
Step 5
Quality of life assessment
Your quality of life will be assessed at various points during the study using a questionnaire. This helps to understand how the treatment affects your daily life and well-being.
Step 6
Completion of the study
At the end of the study, a final assessment will be conducted. This will include a review of your overall health and any changes that have occurred during the study period.

Who can join the trial?

19 criteria

Signed informed consent form, which means you agree to participate after understanding the study.
Must have adequate blood and organ function, which includes:
- AST and ALT (liver enzymes) less than 10 times the upper normal limit.
- Serum bilirubin (a liver function marker) less than 3.5 mg/dL.
- Albumin (a protein in your blood) at least 28 g/L.
- Serum creatinine (a kidney function marker) less than or equal to 1.5 mg/dL.
- Hemoglobin (a component of blood) at least 8 mg/dL.
- Platelet count (cells that help blood clot) at least 50 G/L.
- Leukocytes (white blood cells) at least 2.5 G/L.
- If not on blood thinners, INR (a blood clotting test) less than or equal to 2.3 or thromboplastin time at least 40%.
- Women who can have children must agree to avoid pregnancy by not having heterosexual intercourse or using birth control.
- Men must agree to avoid fathering a child by not having heterosexual intercourse or using a condom.
- Must be at least 18 years old.
- Must have Hepatocellular Carcinoma (HCC) confirmed by a doctor through tests.
- Must have worsening disease during treatment with atezolizumab/bevacizumab or stable disease after the first 12 months of this treatment.
- Must have a negative HIV test.
- If you have chronic hepatitis B, you must be on antiviral treatment, and your hepatitis B DNA must be less than 500 IU/mL.
- If you have varices (enlarged veins), their status must be known, and they must be treated properly.
- Must have an ECOG Performance Status of 0-1, which means you are fully active or have some symptoms but can still do light work.
- Must be in Child-Pugh class A-B8, which is a measure of liver function.

Who cannot join the trial?

3 criteria

Patients with other types of cancer besides Hepatocellular Carcinoma cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Fecal Microbiota Transplant (FMT)
is a therapy that involves transferring stool from a healthy donor into the gastrointestinal tract of a patient. The goal is to restore a healthy balance of bacteria in the gut, which can help improve the body's immune response and overall health. In this trial, FMT is being used to see if it can help patients with liver cancer who did not respond to previous treatments.
Atezolizumab
is a type of cancer treatment known as an immunotherapy. It works by helping the body's immune system recognize and attack cancer cells. Atezolizumab blocks a specific protein that prevents the immune system from attacking cancer, allowing the immune system to better target and destroy cancer cells. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with liver cancer.
Bevacizumab
is a medication that helps stop the growth of new blood vessels that tumors need to grow. By blocking the blood supply to the tumor, bevacizumab can help slow down or stop the growth of cancer. In this trial, it is used alongside other therapies to see if it can enhance the treatment effects for patients with liver cancer.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently used in medicine to treat various types of cancer, including hepatocellular carcinoma, and is well-documented in medical literature. The main therapeutic indication for atezolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-L1, which cancer cells use to hide from the immune system. Atezolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.
Bevacizumab
Bevacizumab is also administered as an intravenous infusion, allowing it to enter the bloodstream directly. It is widely used in medicine to treat various cancers, including hepatocellular carcinoma, and is well-supported by medical literature. The main therapeutic indication for bevacizumab is to inhibit the growth of blood vessels that supply nutrients to tumors. At the molecular level, it works by blocking a protein called VEGF, which is responsible for the formation of new blood vessels. Bevacizumab is classified as an angiogenesis inhibitor, a type of drug that prevents the growth of new blood vessels needed by tumors to grow and spread.

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, particularly in individuals with cirrhosis due to hepatitis B or C infection, or alcohol abuse. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As the tumor enlarges, it may cause symptoms such as abdominal pain, weight loss, and jaundice. The progression of hepatocellular carcinoma can lead to liver dysfunction and complications related to the spread of cancer cells. The disease's course can vary significantly depending on the underlying liver condition and the extent of the tumor.