CompletedPhase IIInterventional

ImmunoTACE

Hepatocellular carcinoma is the most common form of primary liver cancer. When surgery to remove the tumour is not possible, doctors often use a treatment called transcatheter arterial chemoembolisation (TACE). TACE delivers chemotherapy directly to the liver while blocking blood flow to the tumour. This trial is looking at whether adding low doses of a chemotherapy drug called cyclophosphamide, with or without a specialised cancer vaccine, can improve how well TACE works. The vaccine is made using your own white blood cells, trained in a laboratory to help your immune system recognise and attack liver cancer cells. Researchers want to find out if this combination can help keep the cancer under control for longer. Half of the participants will receive TACE with cyclophosphamide, and the other half will receive this plus the cancer vaccine.

At a glance

Status

Completed

Phase

Phase II

Sponsor

University of Birmingham (UK)

Enrolment target

Start

06 Jan 2014

Estimated completion

30 Sep 2019

Hepacellular Carcinoma

What is this study about?

Primary liver cancer, known as hepatocellular carcinoma, can be difficult to treat when it cannot be safely removed by surgery or treated with a liver transplant. For many people in this situation, the usual approach is a procedure called TACE. During TACE, a doctor guides a tiny tube into the blood vessels feeding the tumour to deliver chemotherapy and block its blood supply. While TACE can shrink tumours and slow their growth, researchers are constantly searching for ways to make the treatment more lasting.

The ImmunoTACE trial is exploring whether combining standard TACE with immunotherapy can train the body's natural defences to fight back. In this study, patients receive a low dose of a chemotherapy medication called cyclophosphamide. This drug is given to prepare the body by weakening cells that stop the immune system from fighting tumours.

Alongside this, some participants will receive an experimental cancer vaccine. This vaccine is custom-made from a patient's own immune cells (dendritic cells) and mixed with liver cancer proteins. Doctors hope this vaccine will teach the immune system to hunt down and attack remaining cancer cells throughout the liver, helping to keep the disease at bay for longer.

Key takeaways

Tests whether adding a cancer vaccine and low-dose chemotherapy to standard TACE improves liver cancer control.
For adults with primary liver cancer who cannot have surgery or a transplant.
Participants must not have had previous chemotherapy or immunotherapy for liver cancer.
The cancer vaccine is made in a laboratory using your own immune cells.
Taking part is voluntary, and you can withdraw at any point without losing standard care.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with primary liver cancer that can be clearly measured on a CT or MRI scan. It is meant for people who are suitable for TACE treatment, but whose cancer cannot be removed with surgery or cured with a liver transplant.

To be able to join, you must not have had any previous chemotherapy, radiotherapy, or immunotherapy for your liver cancer. You should also be generally well enough to walk around and manage day-to-day self-care, with blood tests showing that your liver, kidneys, and bone marrow are working safely.

Because trial medications can pose risks to an unborn child, women who could become pregnant must have a negative pregnancy test before starting. Both men and women must be willing to use reliable contraception during the study and for six months after treatment ends. You will also need healthy veins so the team can collect blood to make the vaccine.

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.

I am aged 18 or over.
I have been diagnosed with primary liver cancer (hepatocellular carcinoma).
My cancer cannot be treated with surgery or a liver transplant.
I have not previously had chemotherapy, radiotherapy, or immunotherapy for liver cancer.
I am well enough to look after myself and do light daily activities.
I am willing to use effective contraception during the study and for 6 months after.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first attend screening visits to have blood tests, health checks, and scans. If eligible, you will have blood taken through a needle so scientists can collect immune cells to prepare your vaccine. You will receive standard TACE treatment alongside low-dose chemotherapy tablets (cyclophosphamide), and half of the participants will also receive vaccine injections. Throughout the study, you will have regular hospital visits for scans, blood checks, and symptom reviews to monitor how your liver is responding. The active treatment and follow-up usually last over several months.

Potential risks and benefits

Taking part may help shrink your tumour, slow down the cancer, or help doctors design better treatments for people in the future, though personal benefit cannot be guaranteed. You may experience side effects from the TACE procedure (such as tummy pain, fever, or feeling sick), tiredness from cyclophosphamide, or mild flu-like symptoms from the vaccine. The medical team will monitor you closely and offer treatments to help manage any discomfort. Taking part is completely voluntary, and you are free to leave the trial at any time without it affecting your standard NHS care.

Locations (3)

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

Queen Elizabeth Hospital
Unverified
Birmingham, England
Queens Medical Centre
Unverified
Nottingham, England
Aintree University Hospital
Unverified
Liverpool, England

Common questions

What is TACE?

TACE stands for transcatheter arterial chemoembolisation. It is a standard procedure where chemotherapy is injected straight into the blood vessel feeding the liver tumour, followed by a substance that blocks blood flow to starve the cancer.

Is the cancer vaccine like a routine flu jab?

No. Unlike vaccines that prevent infections, this cancer vaccine is a treatment designed to teach your own immune system how to recognise and destroy existing cancer cells.

Can I choose whether I receive the vaccine?

No. A computer will randomly decide whether you receive the vaccine along with TACE and cyclophosphamide, or TACE and cyclophosphamide on their own. This ensures the trial results are fair and reliable.

Will taking part cost me anything?

No, the trial treatments are provided free of charge. You may also be able to get help with travel expenses to and from the hospital.

What happens if I change my mind?

You can leave the trial at any point, for any reason. Your doctors will continue to give you the best available standard care.

How to find out more

David Adams

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.