
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at adding nivolumab to TACE or TAE for people with cancer of the liver. It is for people who have a type of liver cancer called hepatocellular carcinoma (HCC).
TACE involves injecting a substance (such as a gel or tiny beads) that carry a chemotherapy drug into blood vessels in the liver.
TAE works by reducing the blood supply to the liver.
There are a number of different treatments for liver cancer. One treatment is called trans arterial chemoembolisation (TACE) or trans arterial embolisation (TAE).
TACE involves injecting a substance (such as a gel or tiny beads) that carry a chemotherapy drug into blood vessels in the liver. The chemotherapy drug you have in this trial is called doxorubicin.
The beads block the blood supply to the liver. This prevents the cancer getting oxygen and food that it needs to grow. The beads release chemotherapy which can kill the cancer cells.
TAE works by reducing the blood supply to the liver. It involves injecting a substance (such as a gel or tiny beads) into your blood vessel to block the blood supply to the liver tumour. This stops the cancer getting the oxygen and nutrients it needs to survive.
Doctors are trying to improve treatment. In this trial they are looking at a drug called nivolumab. It is a type of immunotherapy. It helps your find and kill cancer cells. It works by blocking a protein called PD-1 on the surface of certain immune cells called
. Blocking this protein activates the T cells to find and kill cancer cells.
Researchers think that nivolumab might improve treatment. But they aren’t sure so want to find out more. In this trial some people have TACE or TAE and nivolumab. And some have TACE or TAE on its own.
The aims of this trial are to find out:
The following bullet points list 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.
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is a phase 2/3 trial. The trial team need 522 people to take part.
It is a randomised trial. You are part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in.
You have 1 of the following:
TACE or TAE
Your doctor will decide on the most appropriate procedure, either TACE or TAE for your condition.
To have TACE your doctor puts a fine tube (catheter) into your groin. They inject a dye to outline the blood vessels and blood supply of the cancer. The doctor injects a substance (such as a gel or tiny plastic beads) into the small arteries feeding the tumour. This blocks the blood flow to the cancer and slowly releases the chemotherapy.
You have TAE in the same way. The doctor injects gel or tiny plastic beads into the small arteries which blocks the blood flow to the cancer.
To have this procedure you have a drug to make you sleepy (sedation). You stay in hospital overnight.
The team arrange your TACE or TAE appointment and tell you when this takes place. You may have TACE or TAE more than once. Your doctor can tell you more if this applies to you.
TACE or TAE and nivolumab
You have TACE or TAE in the same way as described above. You have nivolumab as a drip into a vein. This takes an hour each time.
You have treatment in the following order:
You have nivolumab for up to 2 years as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Follow up
When you finish treatment you see the team every 4 weeks for a check up.
Samples for research
You have some extra blood samples for research. The trial team hope to use these to learn more about hepatocellular liver cancer. They also ask to have a sample of tissue you had collected when you had a biopsy.
The team plan to look for . And they might use the samples for other tests in the future.
Quality of life
The trial team ask you to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire asks about any side effects you have had and how you have been feeling. This is called a quality of life study.
You see a doctor to have some tests before you join the trial. These include:
You might also need to have a sample of tissue taken from the liver.
During treatment you have regular blood tests and check ups with the team.
You have a CT and if required, an MRI scan:
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.
Nivolumab can affect the immune system. It may cause inflammation in different parts of the body which 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.
If you have any of these side effects, you should tell the 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 nivolumab are:
The side effects of TACE or TAE are:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Daniel Palmer
Bristol-Myers Squibb
Clatterbridge Cancer Centre NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”