Recruiting

Study of Fecal Microbiota Transplantation combined with atezolizumab and bevacizumab in patients with unresectable liver cancer who progressed after initial treatment

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 study focuses on patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The research examines the effectiveness of combining Fecal Microbiota Transplantation (FMT) with two medications: atezolizumab and bevacizumab in patients whose cancer has continued to progress despite initial treatment with these drugs.

The treatment involves receiving FMT along with continued administration of atezolizumab and bevacizumab. Atezolizumab works by helping the immune system fight cancer cells, while bevacizumab works by blocking the growth of blood vessels that feed the tumor. Before starting the treatment, patients will need to take medications to clean their bowels, including vancomycin and bowel preparation solutions.

The purpose of this study is to determine whether adding FMT to the existing treatment can help patients whose cancer has worsened within the first four months of their initial therapy. The study will monitor patients for approximately three years to evaluate how well they respond to the treatment and to identify any side effects that may occur.

The research process

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

Step 1
Initial treatment phase
You will receive a combination of two medications through intravenous infusion:
- Atezolizumab (Tecentriq) 1,200 mg as an infusion solution
- Bevacizumab (Avastin) as an infusion solution
This treatment is for patients with liver cancer that cannot be removed by surgery
Step 2
Pre-transplant preparation
Before the fecal microbiota transplantation (FMT), you will receive:
- Oral solution (SELG ESSE) to clean the digestive system
- Additional oral preparation (Plenvu) to ensure complete cleansing
- Vancomycin medication taken by mouth
Step 3
Monitoring phase
Your condition will be monitored for 12 weeks after the transplant procedure
Regular assessments will check how your body responds to the treatment
Blood samples will be taken to analyze various health markers
Samples will be collected to study changes in your gut bacteria
Step 4
Follow-up period
After completing treatment, you need to continue using effective birth control:
- Women: for 6 months after the final treatment
- Men: for 6 months after the final treatment
Regular check-ups will continue to monitor your health status

Who can join the trial?

12 criteria

Age 18 years or older
Must have liver cancer that cannot be surgically removed and has shown early progression (worsening) within 4 months while on Atezolizumab and Bevacizumab treatment
Must have tolerated the initial treatment with Atezolizumab and Bevacizumab without serious side effects requiring permanent discontinuation
Must have at least one measurable tumor that has not been treated
Must have good physical function (ECOG performance status of 0-1, which means able to perform daily activities with minimal limitations)
Must have good liver function (Child-Pugh A, which indicates well-preserved liver function)
Must have adequate blood test results showing proper organ function
Must be willing and able to follow the study protocol requirements
For women who can become pregnant: Must agree to use highly effective birth control (less than 1% failure rate) during treatment and for 5 months after the last dose of Atezolizumab and 6 months after the last dose of Bevacizumab
For men with partners who can become pregnant: Must use effective birth control (condom plus additional method) during treatment and for 6 months after the last dose of Bevacizumab
Must agree not to donate eggs (women) or sperm (men) during the study and for several months after treatment
Must sign an informed consent form

Who cannot join the trial?

15 criteria

History of autoimmune disease requiring systemic treatment within the past 2 years
Active or untreated hepatitis B or hepatitis C infection
Known active tuberculosis infection
Severe liver dysfunction (Child-Pugh class C) - this means severely impaired liver function
Previous organ transplantation
Active or recent gastrointestinal bleeding within the last 3 months
Untreated or unstable brain metastases (cancer that has spread to the brain)
History of allergic reactions to similar biological treatments
Pregnancy or breastfeeding
Any serious medical condition or abnormal laboratory test that could compromise participation in the trial
Current participation in other clinical trials
Inability to provide informed consent
Major surgery within 28 days before starting the treatment
Active infection requiring systemic treatment
History of other malignancies (cancers) within 5 years prior to study entry, except for adequately treated non-melanoma skin cancer or carcinoma in situ

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Verified sites

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Azienda Unita Sanitaria Locale Di Bologna
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Bologna, Italy

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Investigated drugs

Atezolizumab
is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from your immune system, allowing your body's natural defenses to better recognize and attack the cancer.
Bevacizumab
is a medication that works by blocking the growth of new blood vessels that feed tumors. By reducing the blood supply to cancer cells, it helps slow down or stop tumor growth.
Fecal Microbiota Transplantation (FMT)
is a procedure where healthy gut bacteria from a donor are transferred to a patient. This therapy aims to improve the balance of beneficial bacteria in the patient's digestive system, which may help improve the effectiveness of cancer treatments.

What is already known about the treatment

Atezolizumab
An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-L1 inhibitors. This monoclonal antibody works by blocking the PD-L1 protein on cancer cells, enabling the immune system to better recognize and attack cancer cells. It is currently approved for treating various types of cancers, including unresectable hepatocellular carcinoma (HCC), typically used in combination therapy with other medications.
Bevacizumab
A targeted therapy medication given through intravenous infusion that belongs to the class of anti-VEGF monoclonal antibodies. This drug works by blocking the formation of new blood vessels that feed tumors, effectively cutting off their blood supply and limiting their growth. It is commonly used in combination with other cancer treatments, including for unresectable hepatocellular carcinoma (HCC), and has shown significant effectiveness in various cancer types when combined with immunotherapy agents.

Investigated diseases

Hepatocellular Carcinoma (HCC) - A primary liver cancer that begins in the main type of liver cells (hepatocytes). It typically develops in liver tissue that has been damaged by chronic liver diseases, such as cirrhosis. The disease usually starts as small colonies of abnormal cells in the liver that gradually grow larger. As it progresses, these abnormal cell clusters can spread within the liver and potentially affect liver function. The unresectable form means the cancer cannot be completely removed through surgery due to its size, location, or spread within the liver. HCC can affect multiple parts of the liver simultaneously and may develop slowly over time.