
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial is looking at giving pembrolizumab and lenvatinib before surgery for people with liver cancer.
It is open to people with a type of liver cancer called hepatocellular carcinoma.
Surgery is one of the main treatments for liver cancer. The is to just have surgery.
In this study researchers want to see if having drugs before and after surgery might help. The drugs they are looking at are pembrolizumab and lenvatinib.
Pembrolizumab is an immunotherapy. It works by stimulating the to find the cancer cells and attack them. Doctors already use pembrolizumab to treat other types of cancer but not liver cancer.
Lenvatinib is a . It is a cancer growth blocker. Lenvatinib blocks signals that cancer cells need to grow and divide. By blocking these signals it can cause the cancer cell to die.
Lenvatinib also blocks cancer cells from growing new blood vessels. Without new blood vessels the cancer gets less nutrients and oxygen that it needs. This means that it shrinks or stops growing. Doctors use lenvatinib for some cancers including liver cancer that has spread to another part of the body.
Before surgery you might have:
After surgery everyone has pembrolizumab.
The aims of the trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is a phase 2 UK trial. The team need 60 people to take part.
This is a randomised trial. A computer puts you into 1 of 3 groups. Neither you nor your doctor choses which group you are in.
The 3 groups are:
You have pembrolizumab as a drip into a vein. You have it once every 3 weeks. Each 3 week period is a . You have 2 cycles of treatment before surgery.
Lenvatinib is a capsule. You take the capsules once a day every day for 6 weeks before surgery. Your doctor will tell you how many to take.
After surgery everyone has pembrolizumab every 3 weeks for up to a year. This is as long as it is helping and the side effects aren’t too bad.
Diary
You have a diary to write down any side effects that you might have. If you are taking lenvatinib you also write down when you took the capsules and how many you took.
You need to bring this diary with you to every hospital appointment. Your doctor or nurse will go through it with you.
Samples of tissue
The doctor will ask to take a piece of liver cancer tissue ():
You must agree to have these samples taken to take part in the trial.
Your doctor will only take these samples if they think it is safe to do so. If they think it isn’t safe then you won’t be able to take part in the trial.
Samples for research
You give several blood samples during the trial. Your doctor will tell you more about how often and when they take the samples. Where possible they take these samples when you give blood as part of your routine care.
Researchers will use these samples to find out more about liver cancer and how to treat it.
You see the doctor to have tests before taking part. These include:
You see the doctor regularly before surgery. This is to:
You see the doctor a month after surgery and before starting pembrolizumab. This is to see how well you are recovering from surgery.
You then see the doctor every 3 months for a year. You have:
During the follow up if your cancer comes back the doctor will take another tissue sample (biopsy).
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Pembrolizumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
The most common side effects of pembrolizumab are:
The most common side effects of lenvatinib are:
We have more information about:
Your doctor will talk to you about the possible side effects of the treatments before you agree to join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Tim Meyer
University College London (UCL)
Merck, Sharp & Dohme
Cancer Research UK & UCL Cancer Trials Centre
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.