Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A phase III, multicenter, randomized, open-label trial to evaluate the safety and efficacy of systemic therapy with regorafenib and pembrolizumab, versus locoregional therapy with transarterial chemoembolization (TACE) or transarterial radioembolization (TARE), for the first-line treatment of intermediate-stage hepatocellular carcinoma with beyond up-to-7 criteria (REPLACE).

This study, called REPLACE, is for people with a type of liver cancer that has spread beyond a certain point. It's a large-scale study that hopes to confirm how effective these treatments are. Researchers are comparing two different approaches. One approach involves two medicines, regorafenib and pembrolizumab, given into the body. The other approach uses treatments like TACE (transarterial chemoembolization) or TARE (transarterial radioembolization), which are given directly to the liver. The main aim is to find out which treatment helps people live longer without their cancer getting worse, and how safe each treatment is. Researchers will also look at overall survival, how many people respond to treatment, and how long a response lasts.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Translational Research In Oncology

Enrolment target

259

Start

27 Nov 2023

Intermediate-stage hepatocellular carcinoma with beyond up-to-7 criteria.

What is this study about?

This study is called REPLACE, and it's looking into better ways to treat a specific type of liver cancer called hepatocellular carcinoma. This cancer is in an 'intermediate stage,' which means it's still mainly in the liver but has grown a bit more than a very early stage, past what doctors call 'up-to-7 criteria.' The study is comparing two different treatment options to see which one works best.

One treatment involves two medicines: regorafenib and pembrolizumab. These are given to the whole body, usually through an infusion (like a drip). The other treatment involves more focused procedures done directly in the liver, called transarterial chemoembolization (TACE) or transarterial radioembolization (TARE). TACE blocks the blood supply to the tumour and delivers chemotherapy directly to it, while TARE uses tiny radioactive beads to kill cancer cells. The doctors want to find out which approach is better at controlling the cancer.

This is a 'Phase III' study, which means it’s a big, important step to confirm if one of these treatments is better or safer than standard options before it can become more widely available. They will be closely watching important things like how long people live without their cancer getting worse, how long people live overall, and any side effects. This research helps doctors understand the most effective ways to treat this type of liver cancer, potentially leading to improved care for patients in the future.

Key takeaways

This study compares two different treatment approaches for a type of liver cancer.
It aims to find out which treatment is better at stopping cancer growth and improving survival.
Treatments include whole-body medicines (regorafenib + pembrolizumab) or liver-targeted procedures (TACE/TARE).
It's a 'Phase III' study, which is an important step to confirm new treatments.
Participation involves regular clinic visits for treatments and health checks.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have intermediate-stage hepatocellular carcinoma, which is a type of liver cancer. Your cancer must have particular characteristics that doctors describe as 'beyond up-to-7 criteria'.

There will be other specific health checks and medical requirements that only your doctor can tell you about. These are important for your safety and to make sure the study results are clear and helpful for everyone involved.

If you think you might be eligible, the best first step is to talk to your specialist. They can look at your full medical history and see if this study could be an option 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.

Are you at least 18 years old?
Do you have intermediate-stage hepatocellular carcinoma (a type of liver cancer)?
Has your doctor told you your cancer has ‘beyond up-to-7 criteria’ characteristics?
Are you willing to attend regular hospital visits for treatments and health checks?
Have you discussed with your doctor if this study might be suitable for your specific health situation?

Answer every question to see your result.

What does participation involve?

If you join this study, it's considered a long-term commitment. You would receive one of the two treatment approaches being tested: either the medicines regorafenib and pembrolizumab, or a procedure like TACE or TARE. The specific details of how often you receive treatment or have appointments will depend on which treatment group you are in, but it will involve regular visits to the clinic.

During these visits, you will have various assessments, which might include blood tests, scans (like CT or MRI), and physical examinations. These tests help the doctors keep track of your health, how the treatment is working, and if you are experiencing any side effects. The study will continue until your cancer progresses or you need to stop for other reasons. Even after treatment, there will be a follow-up period to monitor your health and gather important information for the study.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than current options for your condition, or you might receive a treatment that is already established. However, there's no guarantee the treatment will work for you, and you might experience side effects, some of which could be serious. All treatments carry risks, and the study team will carefully monitor you for any problems. You will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

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Unverified
Belgium
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Unverified
Spain
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Unverified
Italy
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Unverified
France
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Unverified
Germany
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Unverified
Romania

Common questions

What is hepatocellular carcinoma?

It's the most common type of liver cancer, starting in the main cells of the liver.

What does 'intermediate-stage' mean for liver cancer?

It means the cancer is still mainly in the liver but has grown to a certain size or number of tumours, past criteria that doctors use to describe very early stages.

What are regorafenib and pembrolizumab?

These are medicines given into the body. Regorafenib is a targeted therapy designed to stop cancer growth, and pembrolizumab is an immunotherapy that helps your immune system fight cancer.

What are TACE and TARE?

These are direct treatments for liver tumours. TACE blocks blood to the tumour and delivers chemotherapy. TARE uses tiny radioactive beads to kill cancer cells, both delivered through a thin tube into the liver.

What does 'Phase III' study mean?

It's a large study that compares a new treatment against existing ones to see if it's more effective or safer before it can become a standard treatment.