Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A PHASE IB/II, OPEN-LABEL, MULTICENTER, RANDOMIZED PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT IMMUNOTHERAPY COMBINATIONS IN PATIENTS WITH SURGICALLY RESECTABLE HEPATOCEULLULAR CARCINOMA (MORPHEUS-NEO HCC)

This research study is for people with a specific type of liver cancer called hepatocellular carcinoma, where surgery is usually an option. Scientists are testing new combinations of anti-cancer drugs, including ones called Tecentriq, Avastin, and Tiragolumab. The main goal is to find out if these combinations help shrink the tumour before surgery, making the operation more successful, and to see if they are safe. This study is taking place in different hospitals and is designed to compare these new treatments to see which ones work best for patients.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

25 Oct 2023

Hepatocellular Carcinoma (Morpheus-Neo HCC)

What is this study about?

This study, called MORPHEUS-NEO HCC, is for people in the UK who have a type of liver cancer called hepatocellular carcinoma that can be treated with surgery. Doctors want to see if giving a combination of new drugs before surgery can help improve the outcome for patients. Think of it like taking some medicine first to make the surgery easier or more effective.

Researchers are using several different treatment combinations, including medicines like Tecentriq, Avastin, and Tiragolumab. These are types of medications that work with your body's immune system or blood supply to fight cancer. The study is designed to carefully compare these different options to find out which ones are most effective and safe for patients. By doing this before surgery, doctors hope to achieve better results.

The main things the researchers will be watching for are how much the cancer shrinks before surgery, how many people have no signs of cancer left after surgery, and how long people stay free from cancer or live well after their treatment. They will also be looking very closely at any side effects patients might experience to make sure these treatments are safe.

Key takeaways

It's for a specific liver cancer (hepatocellular carcinoma) that can be removed with surgery.
New drug combinations (like Tecentriq, Avastin, Tiragolumab) are given before surgery.
The aim is to see if these treatments improve surgical success and are safe.
You'll have regular hospital visits for treatments and checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged at least 18 years old. Both men and women are welcome to take part.

Crucially, you would have been diagnosed with a specific type of liver cancer called hepatocellular carcinoma, and importantly, your doctors must believe that your cancer can be removed through surgery.

There will also be other medical checks and criteria that your study doctor will discuss with you to ensure this study is a suitable and safe option for your individual situation.

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 (a type of liver cancer)?
Have your doctors said your liver cancer can be removed by surgery?
Are you prepared 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, you would receive one of the experimental drug combinations as an infusion (given into your vein). This treatment would happen before your planned surgery. You would have regular appointments at the hospital for these infusions, along with blood tests, scans, and other checks to see how your body is responding and to monitor for any side effects. Doctors will measure how much your tumour shrinks before surgery and check how your surgery goes.

After your surgery, you would continue to have follow-up appointments, scans, and tests. This allows the study team to track your progress and long-term health. The total time you would be involved in the study would depend on your treatment plan and ongoing monitoring, but it would involve several months of active treatment and follow-up care.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the new drug combinations might help shrink your cancer before surgery, potentially leading to a more successful operation and better long-term outcomes than standard treatment alone. However, there's no guarantee the treatment will work for everyone, and you might experience side effects. These side effects can range from mild to serious, similar to other cancer treatments. The research team will carefully monitor you for any side effects and support you throughout. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
Austria
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Unverified
Spain
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Unverified
Germany
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Unverified
France

Common questions

What kind of liver cancer is this study for?

This study is specifically for a type of liver cancer called hepatocellular carcinoma that doctors believe can be removed with surgery.

What drugs are being tested?

The study is testing combinations of modern anti-cancer drugs, including Tecentriq, Avastin, and Tiragolumab.

Will I still have surgery if I join this study?

Yes, the study involves giving these medicines before your planned surgery to see if they can improve the surgical outcome.

What are doctors hoping to learn?

Doctors want to see if these new drug combinations can shrink the cancer effectively before surgery, making the surgery more successful, and if they are safe for patients.

How long will I be involved in the study?

You'll be involved during the treatment before surgery, the surgery itself, and then for follow-up appointments to check your long-term health. The exact duration will be discussed with you.