Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1)

This study, called EMERALD-1, is looking at better ways to treat a specific type of liver cancer that is still contained within the liver area (locoregional hepatocellular carcinoma). It's a Phase III study, which means it's one of the final stages of testing before a medicine might be widely used. Participants will receive a standard liver cancer treatment called Transarterial Chemoembolization (TACE). On top of this, they will either get a new drug called durvalumab, a combination of durvalumab and another drug called bevacizumab, or a placebo (a dummy treatment). Scientists want to see if adding these new drugs helps slow down the cancer's growth or improves how long people live, while also checking their quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

Start

16 Feb 2024

Locoregional Hepatocellular Carcinoma (HCC)

What is this study about?

This research study, known as EMERALD-1, is focused on finding more effective treatments for a type of liver cancer called hepatocellular carcinoma (HCC). Specifically, it's for people whose cancer is still in the liver or nearby areas, rather than having spread widely throughout the body.

The study aims to see if combining a common procedure, Transarterial Chemoembolization (TACE), with newer medicines can improve outcomes. TACE is a treatment where doctors block the blood supply to the tumour while delivering chemotherapy directly to it. In this study, some people will receive TACE along with a drug called durvalumab (also known as Imfinzi), which helps the body's immune system fight cancer. Others will get TACE with both durvalumab and another drug called bevacizumab, which helps to stop new blood vessels from feeding the tumour. A third group will receive TACE and a dummy medicine (placebo) to fairly compare the new treatments.

The main goal is to find out if combining TACE with these drugs helps people live longer without their cancer growing or spreading. Researchers will also look at how long people live overall, how much the tumours shrink, and importantly, how these treatments affect a person's quality of life. This is a very important step to hopefully find better ways to treat this kind of liver cancer.

Key takeaways

This study is testing new drug combinations for a type of liver cancer.
It combines standard TACE treatment with newer medicines (durvalumab, with or without bevacizumab).
The main goal is to see if these combinations slow cancer growth and improve life expectancy.
It's a Phase III study, meaning it's in the advanced stages of testing.
Participants will have regular check-ups and monitoring.
Your quality of life during treatment will also be assessed.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older. The study is open to both men and women.

The specific type of cancer you have is important. You must have hepatocellular carcinoma (HCC), and it needs to be what doctors call 'locoregional.' This means the cancer is still contained within the liver or very nearby areas, and hasn't spread to distant parts of the body.

There will be other detailed medical checks to make sure the treatment is safe and suitable for you, and that the study results are clear. Your doctor will be able to tell you if you meet all the requirements.

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.

Are you 18 years old or older?
Have you been diagnosed with hepatocellular carcinoma (liver cancer)?
Is your liver cancer considered 'locoregional' (not widely spread)?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned by chance (like flipping a coin) to one of the treatment groups mentioned – either TACE with durvalumab, TACE with durvalumab and bevacizumab, or TACE with a placebo. This helps make the study fair.

You would have regular visits to the hospital for your treatments, which include the TACE procedure and infusions of the study drugs. These visits would also involve careful check-ups, blood tests, and scans (like CT or MRI scans) to monitor your health and how the treatment is working. You might also be asked to fill out questionnaires about how you are feeling and your quality of life.

Throughout the study, the medical team will keep a close eye on you. The total length of your participation would depend on how your cancer responds to treatment, but there will be regular follow-up appointments even after treatment ends.

Potential risks and benefits

Taking part in a clinical trial might offer benefits like access to new treatments before they are widely available, and careful monitoring of your health. However, there are also potential risks; the new drugs may have side effects, some of which could be serious, and the treatment might not work for everyone. The specific risks and known side effects of each medicine will be fully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
France
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Unverified
Spain

Common questions

What is 'locoregional hepatocellular carcinoma'?

It's a type of liver cancer that is still mostly within the liver or very nearby areas, and hasn't spread to other parts of your body.

What is TACE?

TACE stands for Transarterial Chemoembolization. It's a procedure where doctors block the blood vessels feeding the tumour and deliver chemotherapy directly to the cancer in your liver.

What are durvalumab and bevacizumab?

These are types of cancer medicines. Durvalumab works with your immune system to fight cancer, and bevacizumab helps by stopping new blood vessels from growing to feed the tumour.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It's used to compare the new treatments fairly.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which specific treatment you are receiving until the study is over. This helps ensure fair results.