
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing an experimental drug called lenvatinib with an approved drug called sorafenib for people with a type of primary liver cancer called hepatocellular carcinoma.
Doctors use a number of different treatments for hepatocellular carcinoma (HCC). If it is not possible to remove the cancer with surgery, one treatment your doctor may recommend is sorafenib. This is a standard treatment for some people with advanced HCC.
Lenvatinib (previously known as E7080) targets certain proteins on cancer cells or on blood vessels including receptors for vascular endothelial growth factor (VEGF).
VEGF helps cancers to grow blood vessels, so they can get food and oxygen from the blood. All cancers need a blood supply to be able to survive and grow. Lenvatinib blocks the receptor for this protein, stopping VEGF binding to it. This prevents the cancer from developing new blood vessels and hopefully stops the cancer from growing.
Lenvatinib has been looked at in trials in other types of cancer including thyroid cancer, and in an earlier small study for people with HCC. The researchers now want to compare lenvatinib with sorafenib.
The main aims of this trial are to find out
You may be able to join this trial if all of the following apply.
You cannot join this trial if a scan has shown that your HCC
And as well as the above, you cannot join if any of these apply. You
This is an international phase 3 trial. The researchers need 940 people to join worldwide.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in. But you will both know which treatment you are having.
Whichever drug you have, you take it by mouth. If you have lenvatinib, you take 2 or 3 capsules once a day depending on your body weight. The trial team will tell you how many capsules you need to take. You cannot take certain medicines during the research study. This includes aspirin (at any dose) and any medicines that contain aspirin.
If you have sorafenib, you take 2 tablets twice a day.
Whichever group you are in, you have treatment for as long as it is helping you and you don't have bad side effects.
The trial team will monitor you closely during treatment. If you have bad side effects, your doctor may stop your treatment for a while, lower the dose of the drug, or stop your treatment permanently.
They will ask you to fill out 3 questionnaires before you start treatment, every 4 weeks during treatment and after you finish treatment. These questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctors and have some tests to decide whether you can take part in this trial. The tests include
You may have some of these tests again before you start treatment.
You go to hospital about every 2 weeks during treatment. A trial doctor will also telephone you a week after you start treatment, to check how you are.
At these 2 weekly appointments, your doctor will ask you how you are and about any side effects you are having. Your tests will include
If you have lenvatinib, you will need to have some extra blood tests that the group taking sorafenib will not have. So every 4 weeks, you have an extra blood test before and after taking lenvatinib.
Every 2 months you have
You have a scan again when you finish treatment (unless you have had one in the last 4 weeks).
After you finish treatment, you will see the doctors every 3 months. Or if this is not possible, the trial team may telephone you to ask how you are. You may have some further scans.
As lenvatinib is a new drug, there may be side effects we don’t know about yet. The most common side effects we do know about include
The most common side effects of sorafenib include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Debashis Sarker
Eisai
NIHR Clinical Research Network: Cancer
Quintiles
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”