All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

This research study is investigating a new treatment approach for primary liver cancer (hepatocellular carcinoma, or HCC) in people who have had their cancer removed by surgery or another procedure, but who are at high risk of it returning. The study aims to see if combining two drugs, atezolizumab and bevacizumab, can help prevent the cancer from coming back more effectively than just having regular check-ups (called active surveillance). Researchers want to find out if this drug combination is both safe and effective. Participants will be closely monitored to track their health and whether the cancer reappears, helping us understand the best ways to keep liver cancer from returning after initial treatment.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
668
Start
31 Dec 2019
Estimated completion
15 May 2026

Results

Results from this study

Posted November 2023

Results have been published for this study.

Primary outcome
Recurrence-Free Survival (RFS), as Determined by IRF
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).
Full results on the registry

What is this study about?

This study is for people who have been treated for a type of liver cancer called hepatocellular carcinoma (HCC). HCC is the most common kind of primary liver cancer and can sometimes come back even after successful surgery or other procedures to remove it. This study is focusing on individuals who are considered to have a high chance of their cancer returning.

The main aim of this study is to compare a new treatment approach with the current standard of care. The new approach involves giving two drugs together, atezolizumab and bevacizumab, after the cancer has been removed. Atezolizumab works by helping your body's immune system fight the cancer, while bevacizumab aims to stop the cancer from growing its own blood supply. The standard approach for people at high risk is usually 'active surveillance,' which means regular check-ups and scans to catch any recurrence early.

Researchers want to see if the combination of atezolizumab and bevacizumab can reduce the risk of the liver cancer coming back. They will be carefully checking how well the treatment works and if there are any side effects. By taking part, you could contribute to understanding better ways to prevent liver cancer from returning in the future.

Key takeaways

  • This study evaluates new drugs to prevent liver cancer from returning after surgery.
  • It compares a drug combination (atezolizumab plus bevacizumab) with regular check-ups.
  • The study is for people considered at high risk of their liver cancer coming back.
  • You would receive either the drugs or regular monitoring, decided randomly.
  • Your health and any recurrence will be closely tracked throughout the study.

Who may be eligible?

To be part of this study, you would generally need to have been recently diagnosed with a specific type of liver cancer (HCC) and have had it completely removed by surgery or a procedure like radiofrequency or microwave ablation. You also need to have fully recovered from that procedure within a certain timeframe, typically 4-12 weeks before joining. Importantly, your doctors must believe you are at a high risk of your cancer coming back.

There are also some general health requirements. For example, your liver should be working fairly well, and you should be able to carry out your normal daily activities without too much difficulty. For women who could become pregnant, and for men, strict contraception will be required during the study. You would also need to provide a sample of your original tumour tissue if you had surgery.

Some things would prevent you from joining, such as if scans show your cancer has already returned or spread, or if you have certain other serious health conditions like specific types of autoimmune diseases. If you have been treated with a procedure called TACE more than once after your surgery, you also wouldn't be able to join. The study also cannot include individuals with certain rare types of liver cancer.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you recently had liver cancer (HCC) completely removed by surgery or ablation?
  2. Do your doctors consider you to be at high risk of your liver cancer returning?
  3. Are you generally well and able to carry out your daily activities?
  4. Do you have good liver function as assessed by your doctor?
  5. Are you able to use strict contraception if you are a woman who could become pregnant, or a man?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first undergo a series of medical checks and tests to confirm you are eligible. Once enrolled, you would either receive the study drugs (atezolizumab and bevacizumab) or be placed into the active surveillance group, which means having regular check-ups and scans. This decision is made randomly, like flipping a coin.

If you are in the drug treatment group, you would receive these medications as infusions (through a drip into your vein) over a period of time, likely at regular intervals. Throughout the study, all participants will have frequent visits to the clinic for blood tests, physical examinations, and scans (like CT or MRI) to monitor your health and check for any signs of the cancer returning or any side effects from the treatment. The total duration of active treatment and follow-up will be carefully explained to you by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving close medical monitoring and access to a promising new treatment that might help prevent your liver cancer from returning. However, there are also potential risks, including side effects from the study drugs, which can vary from mild to severe, or the possibility that the new treatment may not be more effective than standard care. You will be fully informed about all known risks and benefits before deciding to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (134)

  • Kaiser Permanente Los Angeles
    Verified postcode
    Los Angeles, United States
  • Mercy Medical Center
    Verified postcode
    Baltimore, United States
  • Henry Ford Health System
    Verified postcode
    Detroit, United States
  • Columbia University Medical Center
    Verified postcode
    New York, United States
  • Thomas Jefferson University
    Verified postcode
    Philadelphia, United States
  • The University of Texas Southwestern Medical Center at Dallas
    Verified postcode
    Dallas, United States
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Swedish Cancer Inst.
    Verified postcode
    Seattle, United States
  • St Vincent's Hospital Sydney
    Verified postcode
    Darlinghurst, Australia
  • Lkh-Univ. Klinikum Graz
    Verified postcode
    Graz, Austria
  • Klinikum Klagenfurt am Wörtersee
    Verified postcode
    Klagenfurt, Austria
  • Medizinische Universität Wien
    Verified postcode
    Vienna, Austria

Common questions

What is 'active surveillance'?

Active surveillance means you'll have regular hospital visits, scans, and blood tests to monitor your health and check if your cancer returns, rather than receiving specific drug treatment.

What are atezolizumab and bevacizumab?

These are two different medications. Atezolizumab helps your immune system fight cancer, and bevacizumab works by stopping the cancer from forming new blood vessels to grow.

Who is considered 'high risk' for cancer recurrence?

Your doctors will determine if you're at high risk based on specific features of your liver cancer and its previous treatment.

Will I definitely get the new drug treatment?

Participants are randomly assigned to either receive the drug treatment or active surveillance. This is like drawing lots, so you won't know which group you're in until after you join.

How long will I be in the study?

The study involves different phases of drug treatment and follow-up, which the study team will explain in detail. The total duration can vary for individuals.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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