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A Study of Atezolizumab and Bevacizumab Before and After Surgery in Patients with Liver Cancer at High Risk of Coming Back

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What is this trial about?

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

This study involves patients with hepatocellular carcinoma, which is a type of liver cancer that can be removed by surgery. The study will test two medications called atezolizumab and bevacizumab, which are both types of medicines known as monoclonal antibodies. These medications will be given together as a treatment before surgery (to help shrink the tumor) and after surgery (to help prevent the cancer from coming back). Both medications are given through a tube into a vein, which is called an infusion.

The purpose of the study is to see how well the combination of these two medications works in preventing the cancer from returning after surgery. The study will also look at how safe these medications are when used together in this way. Patients in this study will receive the medications for a period of time before having surgery to remove the cancer, and then continue receiving the medications after surgery. During the study, doctors will check the cancer using scans and other tests to see if it is shrinking before surgery and to watch for any signs of it coming back after surgery. The total treatment time with the medications can last up to fourteen months.

Throughout the study, doctors will carefully monitor patients for any side effects or problems that might occur from the treatment. They will also collect small samples of the tumor tissue before surgery and during surgery to study how the cancer responds to the medications. Patients will need to have regular check-ups and scans during and after treatment so doctors can measure how well the treatment is working and watch for any signs of the cancer returning.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial tumor biopsy
A tumor biopsy will be performed at the beginning of the study. This involves taking small tissue samples from the tumor using a needle.
At least two tissue samples will be collected. If a recent biopsy was performed within 3 months before joining the study and no cancer treatment was received since then, that tissue may be used instead of a new biopsy.
The tissue samples will be examined in a laboratory to analyze the tumor characteristics.
Step 2
Neoadjuvant treatment phase
Treatment will begin with a combination of two medications given before surgery. This is called neoadjuvant treatment, which means treatment given before the main procedure to help improve outcomes.
The medications used are atezolizumab (brand name Tecentriq) and bevacizumab (brand name Avastin).
Atezolizumab will be administered at a dose of 1,200 mg as an infusion, which means it will be given slowly through a vein.
Bevacizumab will be administered at a concentration of 25 mg per milliliter as an infusion through a vein.
Both medications will be given during the same visit. The infusions will be repeated at regular intervals as determined by the treatment schedule.
This treatment phase will continue until the surgical evaluation determines readiness for surgery.
Step 3
Surgical restaging evaluation
Imaging tests will be performed to evaluate how the tumor has responded to the neoadjuvant treatment.
The medical team will assess whether the tumor is ready to be surgically removed and whether surgery can proceed as planned.
This evaluation should occur within 28 days before the planned surgery date.
Step 4
Surgery
Surgery will be performed to remove the tumor from the liver. The goal is to achieve R0 resection, which means removing all visible tumor tissue with clear margins.
During surgery, additional tissue samples will be collected from both the tumor area and surrounding normal tissue. These samples will be preserved in different ways for further analysis.
The surgical team will document details such as the duration of surgery, amount of blood loss, and whether blood transfusion is needed.
Step 5
Post-surgery recovery monitoring
Recovery will be monitored in the hospital following surgery. The length of hospital stay will depend on individual recovery progress.
Any complications related to surgery will be assessed and classified according to their severity.
Mortality within 90 days after surgery will be tracked as part of safety monitoring.
Step 6
Adjuvant treatment phase
After recovery from surgery, treatment with atezolizumab and bevacizumab will resume. This is called adjuvant treatment, which means treatment given after surgery to reduce the risk of cancer returning.
Atezolizumab at 1,200 mg and bevacizumab at 25 mg per milliliter will be administered as infusions through a vein.
The infusions will be given at regular intervals according to the treatment schedule.
This treatment phase will continue for a predetermined duration as specified in the study protocol.
Step 7
Regular monitoring and imaging
Regular follow-up visits will be scheduled throughout the treatment period and afterward.
Imaging tests will be performed at specific intervals to check for any signs of cancer recurrence.
Blood tests will be conducted to monitor liver function, kidney function, blood cell counts, and other health indicators.
Any side effects or adverse reactions to the medications will be recorded and assessed for severity.
Step 8
Long-term follow-up
After completing the adjuvant treatment, regular follow-up visits will continue to monitor for cancer recurrence and overall health status.
The follow-up period will extend for several years to assess long-term outcomes, including recurrence-free survival (time without cancer returning) and overall survival.
Imaging studies and clinical assessments will be performed at scheduled intervals during this follow-up period.

Who can join the trial?

20 criteria

You must sign a document called an Informed Consent Form, which means you agree to take part in the study after understanding all the details
You must be at least 18 years old when you sign the consent form
You must have liver cancer that has been confirmed by examining tissue under a microscope
Your liver cancer must be able to be completely removed by surgery with the goal of curing the disease
Your liver cancer must have a high risk of coming back, which means it has one or more of these features: multiple tumors, a tumor larger than 5 centimeters, a blood protein called alpha-fetoprotein that is 400 or higher, cancer cells that look very abnormal, or cancer that has spread into small blood vessels in the liver
If your tumor is between 3 and 5 centimeters in size, a special scoring system will be used to check if cancer has likely spread into small blood vessels
You must have at least one tumor that can be measured using imaging scans
You must have no or only minor portal hypertension, which is high blood pressure in the vein that brings blood to the liver, if you need a smaller surgery removing fewer than 3 sections of the liver
You must be willing to have a small piece of tumor tissue removed with a needle before treatment starts, or provide tumor tissue collected within the past 3 months if you have not received any cancer treatment since then
You must not have received any previous treatment for liver cancer, including treatments delivered directly to the liver or medicines given through the bloodstream
Your blood tests must show adequate function of your blood cells, liver, and kidneys, including having enough white blood cells, red blood cells, and platelets without needing transfusions or growth factors
Your liver and kidney function tests must be within acceptable ranges
If you have hepatitis B virus, the amount of virus in your blood must be low, you must have started treatment at least 14 days before beginning the study, and you must continue this treatment during the study
If you have hepatitis C virus, you are eligible whether the infection has cleared or is ongoing
If you have HIV, you must be on stable treatment with specific blood test results showing the infection is well controlled
If you are a woman who can become pregnant, you must agree to use birth control or not have sexual intercourse during the study
If you are a man, you must agree to use birth control or not have sexual intercourse during the study, and not donate sperm
Your ECOG Performance Status must be 0, which means you are fully active and able to carry out all activities without restrictions
Your liver function must be classified as Child-Pugh Class A, which means your liver is working relatively well despite having disease
You must be able to follow all study requirements in the opinion of the study doctor

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are reasons why a person cannot join a study, but this information was not included in the available trial documentation
Without detailed exclusion criteria listed, it is not possible to determine which patients would be prevented from participating in this study

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hestia Duran I Reynals
L'hospitalet De Llobregat, Spain
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Hospital General Universitario Gregorio Maranon
Madrid, Spain
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Hospital Universitari De Girona Doctor Josep Trueta
Girona, Spain

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Investigated drugs

Atezolizumab
is a type of cancer immunotherapy medicine that helps your immune system recognize and fight cancer cells. It works by blocking a protein that prevents immune cells from attacking the tumor, allowing your body's natural defenses to work against the cancer.
Bevacizumab
is a targeted therapy medicine that works by blocking the growth of new blood vessels that tumors need to grow and spread. By cutting off the blood supply to the cancer, it helps slow down or stop the tumor's growth.

What is already known about the treatment

Atezolizumab
Atezolizumab is a medication given through an intravenous infusion (directly into a vein) that belongs to a class of drugs called immunotherapy or cancer immunotherapy. It works by blocking a protein called PD-L1 on cancer cells, which allows the body's immune system to recognize and attack the cancer cells more effectively. This medication is approved for treating various types of cancer and is currently being studied in clinical trials for liver cancer (hepatocellular carcinoma) to help prevent the cancer from coming back after surgical removal of the tumor.
Bevacizumab
Bevacizumab is a medication administered through an intravenous infusion (directly into a vein) that belongs to a group of drugs known as targeted therapy or anti-angiogenic agents. It works by blocking a protein called VEGF that helps tumors grow new blood vessels, essentially cutting off the blood supply that cancer cells need to grow and spread. This medication is approved for treating several types of cancer including colorectal, lung, and kidney cancer, and is being investigated in combination with other treatments for liver cancer (hepatocellular carcinoma) to improve outcomes after surgery.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma is a type of cancer that originates in the liver cells called hepatocytes. This disease typically develops in people with chronic liver conditions, such as long-term inflammation or scarring of the liver. The cancer begins when liver cells start to grow and divide in an uncontrolled manner, forming a tumor. As the disease progresses, the tumor can grow larger and may spread to other parts of the liver or beyond. In its early stages, the cancer may not cause noticeable symptoms, but as it advances, patients may experience weight loss, abdominal pain, or yellowing of the skin. The disease can recur even after surgical removal of the tumor, particularly in patients who are at high risk.