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Study on the Safety and Effectiveness of 166Holmium Radiation Therapy with Atezolizumab and Bevacizumab for Patients with Non-Resectable 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 a type of liver cancer called Hepatocellular Carcinoma (HCC) that cannot be removed with surgery. The study is testing a new treatment approach that combines a special type of radiation therapy called 166Holmium radiation therapy with two medications, Atezolizumab and Bevacizumab. Atezolizumab, also known by its code name RO5541267, and Bevacizumab are both given as solutions through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see if adding 166Holmium radiation therapy to the combination of Atezolizumab and Bevacizumab can provide additional benefits for patients with non-resectable HCC. Participants in the study will receive these treatments and will be monitored over time to assess the safety and effectiveness of this combination. The study will involve regular check-ups and imaging tests like CT scans or MRI to track the response of the cancer to the treatment.

Throughout the study, researchers will also look at how the treatment affects the immune system and identify any side effects that may occur. The study aims to gather information on how well the treatment works and how it impacts the body, which could help improve future treatment options for people with this type of liver cancer.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
Blood tests and imaging studies such as CT scans or MRIs are performed to evaluate the condition of the liver and the presence of hepatocellular carcinoma (HCC).
Step 2
Treatment initiation
The treatment begins with the administration of atezolizumab and bevacizumab. These medications are given as a solution for infusion through an intravenous route.
Atezolizumab is administered at a dose of 1,200 mg, and bevacizumab is given at a concentration of 25 mg/ml. The frequency and duration of administration are determined by the clinical investigation plan.
Step 3
166holmium radiation therapy
Selective intra-arterial 166Holmium radiation therapy is introduced to enhance the treatment effect. This therapy targets the liver tumor directly.
The procedure involves delivering radiation directly to the tumor site, aiming to improve the response rate and control the disease.
Step 4
Ongoing monitoring
Regular follow-up visits are scheduled to monitor the response to treatment and assess any side effects.
Imaging studies and blood tests are repeated at specified intervals to evaluate the tumor's response and adjust treatment as necessary.
Step 5
Evaluation of treatment response
The primary endpoint is assessed at 6 months, focusing on the objective response rate, which includes complete or partial response according to specific imaging criteria.
Secondary endpoints include additional assessments at 12 weeks, 6 months, and 12 months, evaluating overall response, progression-free survival, and overall survival.
Step 6
Completion of trial
The trial is estimated to conclude by August 2026. Final assessments are conducted to determine the long-term efficacy and safety of the treatment combination.
Participants are provided with a summary of their treatment outcomes and any further recommendations for their care.

Who can join the trial?

18 criteria

Men and women who are 18 years old or older.
Patients must understand, sign, and date the written informed consent form before any study-specific procedures are done.
Patients should be able to follow the study procedures, including giving tissue and blood samples, and be willing to attend study visits and procedures.
Patients must have a confirmed diagnosis of **Hepatocellular carcinoma (HCC)**, which is a type of liver cancer.
The cancer should be classified as **Barcelona Clinic Liver Cancer (BCLC) stage C**, which is a way to describe the stage of liver cancer.
The cancer should be considered **non-resectable**, meaning it cannot be removed by surgery, as determined by a team of doctors and a liver surgeon. The patient should also not be eligible for a liver transplant.
Patients should be eligible for a first-line treatment with a combination of **Atezolizumab** and **Bevacizumab**, which are medications used to treat liver cancer. Patients who have had local therapy before are also eligible.
Patients must have active liver cancer within the liver (**intrahepatic HCC**).
Patients with or without active viral infections like **HCV** (Hepatitis C Virus) or **HBV** (Hepatitis B Virus) can participate. If the patient has active hepatitis B, they should be treated with anti-HBV therapy during the study.
Patients should have measurable disease as defined by **mRECIST criteria**, which is a way to assess how the cancer responds to treatment.
Patients should have an **ECOG status** of 0 or 1, which is a scale used to assess how well a patient can perform daily activities.
Patients should have a life expectancy of at least 12 weeks at the time of giving consent, as assessed by the doctor.
Patients must have adequate organ function, which includes specific levels of white blood cells, platelets, hemoglobin, creatinine, liver enzymes (ALT and AST), lipase, amylase, and bilirubin.
Patients should have a **Child-Pugh A** liver function status, without a history of brain-related complications (encephalopathy) or significant fluid buildup in the abdomen (ascites).
Women who can have children must have a negative pregnancy test before joining the study and agree to use two effective methods of birth control or abstain from sexual activity during the study and for at least 6 months after the last treatment.
Sexually active male patients must agree to use a condom during the study and for at least 7 months after the last treatment. It is also recommended that their female partners use a highly effective method of birth control for the same duration.
Patients must be willing to undergo tumor biopsies before and during the treatment. Patients who do not agree to a pre-treatment biopsy or do not have accessible tumors will not be eligible.
Patients must be part of a social security system or have similar benefits.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not **Hepatocellular carcinoma (HCC)**, which is a type of liver cancer.
Patients who have had surgery to remove the liver cancer, as the study is for those with **non-resectable** cancer, meaning it cannot be removed by surgery.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who are pregnant or breastfeeding, as the study may involve risks to the baby.
Patients with certain medical conditions that might interfere with the study treatment or outcomes.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent heart attack or severe heart problems.
Patients with severe infections that are not well controlled.
Patients with a history of severe allergic reactions to the study drugs.

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Verified sites

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

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Centr Georges Francois Leclerc
Dijon, France
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Centre Hospitalier Universitaire De Dijon
Dijon, France
Verified
Centre Hospitalier Universitaire De Montpellier
Montpellier, France

Trial locations

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Investigated drugs

Atezolizumab
is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. It is often used in combination with other treatments to improve its effectiveness.
Bevacizumab
is a medication that helps to slow the growth of new blood vessels. This can help to starve tumors of the nutrients they need to grow, making it a useful treatment for certain types of cancer.
166Holmium SIRT
is a type of radiation therapy that is delivered directly to the liver through the arteries. It uses tiny radioactive beads to target and destroy cancer cells in the liver, while minimizing damage to surrounding healthy tissue.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered intravenously and is currently used in clinical settings for various cancers, including non-resectable hepatocellular carcinoma (HCC). It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, allowing the immune system to better attack cancer cells. Atezolizumab is classified as a monoclonal antibody and is well-documented in medical literature for its role in cancer immunotherapy.
Bevacizumab
Bevacizumab is given through intravenous infusion and is widely used in the treatment of several types of cancer, including non-resectable hepatocellular carcinoma (HCC). It functions by inhibiting vascular endothelial growth factor (VEGF), which reduces the blood supply to tumors, thereby slowing their growth. Bevacizumab is classified as an angiogenesis inhibitor and is extensively studied in medical literature for its effectiveness in cancer treatment.
166Holmium
166Holmium is administered via selective intra-arterial radiation therapy and is being investigated for its potential in treating non-resectable hepatocellular carcinoma (HCC). It works by delivering targeted radiation directly to the tumor, minimizing damage to surrounding healthy tissue. 166Holmium is classified as a radioisotope used in selective internal radiation therapy (SIRT) and is currently under clinical investigation to assess its safety and efficacy in combination with other cancer therapies.

Investigated diseases

Hepatocellular Carcinoma (HCC) – Hepatocellular carcinoma is a type of liver cancer that originates in the main type of liver cell, known as hepatocytes. It is often associated with chronic liver diseases, such as cirrhosis or hepatitis B and C infections. 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 like abdominal pain, weight loss, and jaundice. The progression of HCC can vary, with some tumors growing slowly while others may spread rapidly. It is considered non-resectable when surgery is not an option due to the size, location, or spread of the tumor.