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RecruitingPHASE3INTERVENTIONAL

The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

The ABC-HCC study is a research trial for people with intermediate-stage liver cancer, known as hepatocellular carcinoma (HCC). It's comparing a new drug combination, atezolizumab and bevacizumab, to a common treatment called TACE (Transarterial Chemoembolization). The main goals are to find out if the new drug combination is better at treating the cancer and is safe to use. Researchers also want to understand how these treatments affect a person's general well-being and quality of life. About 434 patients will take part in this study, which will be carried out in many hospitals across different countries. If you have intermediate-stage HCC, your doctor might discuss this study with you.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Enrolment target
434
Start
06 Jul 2021
Estimated completion
01 Jul 2027

What is this study about?

This study, called the ABC-HCC trial, is looking into new ways to treat a type of liver cancer that doctors call hepatocellular carcinoma, or HCC. Specifically, it's for people whose cancer is considered 'intermediate stage.' This means the cancer is present but might not be suitable for surgery or other 'curative' treatments, but it's not yet widespread.

The main idea is to compare two different ways of treating this cancer. One approach uses a combination of two medicines, atezolizumab and bevacizumab. The other approach uses a standard treatment known as Transarterial Chemoembolization (TACE). TACE involves delivering drugs directly to the tumour in the liver through a small tube. The study wants to see if the new drug combination works better and is safer than TACE for these patients.

Beyond just seeing if the treatments shrink the cancer, the researchers are also interested in how these treatments affect your overall health, your quality of life, and how well your liver functions over time. They will also look for special markers in your body that might help predict how well a treatment will work for you. This kind of research is important because it helps doctors find better ways to care for people with liver cancer.

Key takeaways

  • This study compares a new drug combination with a standard treatment (TACE) for intermediate-stage liver cancer.
  • It aims to find out which treatment is safer and more effective.
  • About 434 patients will be randomly assigned to one of two treatment groups.
  • Your general health, liver function, and quality of life will be closely monitored.
  • You can leave the study at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you would need to be at least 18 years old and have been diagnosed with intermediate-stage liver cancer (hepatocellular carcinoma or HCC). Your doctor would confirm this diagnosis, either through a tissue sample or special scans like CT or MRI. Importantly, your cancer should not be suitable for surgery, a liver transplant, or other 'curative' treatments, but it should be suitable for the TACE procedure (one of the treatments being compared).

There are also some specific health requirements. Your liver and bone marrow need to be working well, and you should be generally healthy enough, as measured by a score called ECOG performance status 0-1. Your doctor would check various blood tests, including bilirubin and urine protein levels, to ensure they fall within certain limits. You also need to have a life expectancy of at least three months.

Some conditions would prevent you from joining. For instance, if your cancer has spread outside your liver, if you have a very widespread or specific type of liver tumour, or if there's a blockage in a main blood vessel to your liver, you would not be able to participate. Your doctor would carefully review all your medical information to see if this study is right for you.

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. Are you at least 18 years old?
  2. Do you have a confirmed diagnosis of intermediate-stage liver cancer (HCC)?
  3. Is your liver cancer not suitable for surgery or transplant, but your doctor thinks TACE could be an option?
  4. Do you have good general health and acceptable liver and blood test results?
  5. Has your cancer not spread beyond your liver?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two treatment groups: either the drug combination (atezolizumab plus bevacizumab) or the TACE procedure. Being 'randomly assigned' means it's like flipping a coin, so neither you nor your doctor chooses which treatment you receive. This helps make the study fair.

You would have regular visits to the hospital for treatment, check-ups, and tests like blood samples and scans. The medical team would monitor your health and how you react to the treatment very closely. This study is described as 'open-label,' which means both you and your doctor will know which treatment you are receiving. The total duration of your participation would depend on how your cancer responds to treatment and how you are feeling, but there will be ongoing follow-up to monitor your health.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment combination that could be more effective than standard care for your liver cancer. Your health would be very closely monitored by a dedicated medical team, and you would receive expert care. However, new treatments can have side effects that are not fully known, or they might not work as well as expected. TACE, while a standard treatment, also has its own known side effects. It's important to weigh these up. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (72)

  • LKH - Univ. Klinikum Graz
    Verified postcode
    Graz, Austria· Recruiting
  • Medzinische Universität Innsbruck
    Verified postcode
    Innsbruck, Austria· Recruiting
  • Klinikum Klagenfurt am Wörthersee
    Verified postcode
    Klagenfurt, Austria· Recruiting
  • Ordensklinikum Linz
    Verified postcode
    Linz, Austria· Recruiting
  • Universitätsklinikum St. Pölten
    Verified postcode
    Sankt Pölten, Austria· Recruiting
  • Medizinische Universität Wien
    Verified postcode
    Vienna, Austria· Recruiting
  • Institut Sainte-Catherine
    Verified postcode
    Avignon, France· Recruiting
  • Hôpital Jean-Verdier Avicenne
    Verified postcode
    Bobigny, France· Recruiting
  • CHU Bordeaux
    Verified postcode
    Bordeaux, France· Recruiting
  • CHU Clermont-Ferrand CHU Estaing
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • Beaujon Hospital
    Verified postcode
    Clichy, France· Recruiting
  • CHU Grenoble
    Verified postcode
    Grenoble, France· Recruiting

Common questions

What is intermediate-stage liver cancer?

Intermediate-stage liver cancer means the cancer is present in your liver, but it hasn't spread to other parts of your body. It might not be suitable for surgery, but can often be treated to control its growth.

What are atezolizumab and bevacizumab?

These are types of medicines called targeted therapies. Atezolizumab helps your body's immune system fight the cancer, and bevacizumab helps to starve the cancer by blocking new blood vessel growth to the tumour.

What is TACE?

TACE stands for Transarterial Chemoembolization. It's a procedure where doctors deliver cancer-fighting drugs directly to the liver tumour through a small tube, and then block the blood supply to the tumour to help kill the cancer cells.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know whether you are receiving the drug combination or TACE.

How long will I be in the study?

The length of your participation would depend on how your body responds to the treatment. The study team will monitor you closely and explain the schedule of visits and follow-up.

How to find out more

Peter Galle, Prof. Dr.

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

Interested in taking part?

Register your interest

Share your details and the research team for "The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transar…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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