A trial looking at using chemotherapy, a cancer vaccine and chemoembolisation for liver cancer (ImmunoTACE)

Cancer type:

Liver cancer

Status:

Open

Phase:

Phase 2

This trial is for people with hepatocellular carcinoma (HCC), a type of liver cancer. It is comparing two treatments.

One treatment is a combination of a cancer vaccine, chemotherapy and chemoembolisation. The other treatment is chemotherapy and chemoembolisation. The researchers want to find which is better.

More about this trial

Chemoembolisation is also called trans arterial chemoembolisation (TACE). It means you have chemotherapy directly into the area of the liver that contains the cancer. The doctor then blocks off the blood supply to the tumour. This kills the cancer cells.

When the cancer cells die they release substances that trigger the immune system. The immune system can then recognise and kill more cancer cells. But giving TACE alone does not prevent the cancer from re-growing.

In this trial doctors are looking at using a vaccine made from dendritic cells Open a glossary item. These are a type of white blood cell. They can recognise cancer cells and get the immune system to destroy them (an immune response Open a glossary item).

The doctors also want to see if having a low dose of a chemotherapy drug with the treatment will also help it to work better. They think that it will increase the immune response. The type of chemotherapy is cyclophosphamide.

There will be 2 treatment groups

  • 1 group have TACE and cyclophosphamide
  • The other group have TACE, cyclophosphamide and dendritic cell (DC) vaccine

The main aim of the trial is to see which treatment controls the HCC longest.

Depending on the results of the trial the doctors would also like to see if it would be possible to do a larger trial in the future.

Who can enter

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.

You may be able to join this trial if all of the following apply.

  • You have been diagnosed with HCC
  • You have at least 1 area of cancer that can be measured using a scan
  • You have a Child-Pugh score of 7 or less
  • You are able to have TACE
  • You are not able to have the cancer surgically removed
  • You are not able to have a liver transplant
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance that you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply.

  • Your cancer has spread outside of the liver including into the main portal vein (a large vein that brings blood from your bowel to the liver)
  • You have had chemoembolisation, chemotherapy, radiotherapy or immunotherapy for your HCC
  • You have had either radiofrequency ablation (RFA) or percutaneous ethanol injection (PEI) for your HCC within 6 weeks of joining the trial
  • You have had an experimental treatment or major surgery within 4 weeks of joining the trial
  • You have hepatic encephalopathy
  • You have fluid build up in your tummy (abdomen) called ascites that can’t be treated
  • You have had a serious infection within 2 weeks of joining the trial
  • You have certain heart conditions such as congestive cardiac failure or you have had a heart attack in the last 6 months
  • You have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • You have an active autoimmune disease Open a glossary item
  • You have HIV
  • You have a urine infection
  • You have blockage stopping you passing urine
  • You are allergic or sensitive to cyclophosphamide or any of the contrast mediums Open a glossary item used in the trial
  • You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The doctors need 70 people to take part.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

There are 2 treatment groups

  • 1 group have TACE and cyclophosphamide
  • The other group have TACE, cyclophosphamide and dendritic cell (DC) vaccine

Diagram for ImmunoTACE

The first day of treatment is called Day 1

Both groups have

Day 1
Cyclophosphamide – as a drip into your vein

Day 29
Cyclophosphamide – as a drip into your vein

Day 31
You have TACE treatment and the treatment to block the blood supply to the area.

To have TACE your doctor puts a fine tube (catheter) into your groin. You then have a chemotherapy drug (doxorubicin) through the catheter directly into the area of cancer.

The doctor also injects tiny plastic beads called microspheres (Embozene) to block the blood flow to the cancer.

Day 31 to up to Day38
You stay in hospital for between 4 and 7 days after the TACE treatment

If you continue treatment you have more doses of cyclophosphamide as a drip into your vein on days

  • 60
  • 90
  • 120

TACE, cyclophosphamide and dendritic cell (DC) vaccine group

You have treatment the same as the other group. Your doctors also need to make the vaccine for you to have. They make the vaccine from your own dendritic cells.

Your doctor needs to collect dendritic cells from your blood. They do this using a procedure called leukapheresis (pronounced loo-kah-fur-ee-sis).

To have leukapheresis you have a tube into a vein in each arm.

One tube removes blood. The blood then passes into a machine that removes the white blood cells. The rest of your blood cells and normal blood fluid (plasma) then go back into your body through the tube in your other arm.

You have leukapheresis after randomisation and up to 14 days before Day 1 of your cyclophosphamide treatment.

Day 31
You have the dendritic cell vaccine at the same time as you have TACE. You have the 1st dose of the vaccine through the catheter into your groin at the same time as you have the TACE treatment.

You have more doses of cyclophosphamide as a drip into your vein on days

  • 60
  • 90
  • 120

Then you have the vaccine 2 days after each dose of cyclophosphamide. You have it as a drip into your vein.

If test results show the treatment is working well, the doctors may decide to continue it.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

  • Blood tests
  • A physical examination
  • Heart trace (ECG Open a glossary item)
  • CT scan of your chest
  • CT or MRI scan of your tummy (abdomen)

You go to hospital for all your treatment.

You have the first 2 doses of cyclophosphamide as an outpatient.

You stay in the hospital when you have TACE. This is for between 4 to 7 days.

After your TACE you go back to the hospital once a week for a check up for 3 weeks. You then have the additional doses of cyclophosphamide, and if you are having it, the DC vaccine as an outpatient.

Around 1 month after you have the TACE treatment you have a scan to check how well the treatment has worked on your cancer. This might be a CT or MRI scan. Your doctor will explain which one you’ll have.

After you finish treatment you see the doctors every 3 months for next year. Throughout the time you are in the trial you have regular blood tests.

Side effects

The most common side effects of cyclophosphamide are

The most common side effects of DC vaccine are

  • Aching muscles
  • High temperature (fever)

The most common side effects of TACE are

  • High temperature (fever)
  • Feeling or being sick
  • Mild constipation
  • Tummy (abdominal) pain

We have information on doxorubicin the chemotherapy drug used during TACE.

We also have more information on cyclophosphamide

Location

Birmingham
Liverpool

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor David Adams

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Efficacy and Mechanism Evaluation (EME) Programme
University of Birmingham
 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9660

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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