A study to test whether adding nivolumab to TACE/TAE treatment is effective and safe in patients with intermediate-stage liver cancer
This clinical trial explores a new treatment option for people with intermediate-stage liver cancer (hepatocellular carcinoma) who cannot have surgery to remove their tumour. Currently, the standard NHS treatment is a procedure called chemoembolisation (TACE), which blocks blood supply to the tumour while delivering chemotherapy directly to it. Researchers want to find out whether adding an immunotherapy drug called nivolumab to this standard treatment is safe and more effective. Nivolumab works by helping the body's own immune system recognise and attack cancer cells. Participants are placed into groups by chance to receive either the standard TACE procedure alone or TACE combined with regular doses of nivolumab. The research team will monitor how well the cancer responds and check for side effects. The results could help doctors improve future treatments and outcomes for people living with liver cancer.
At a glance
What is this study about?
Primary liver cancer, often called hepatocellular carcinoma, usually starts in cells within the liver. When the cancer is at an 'intermediate stage', there may be several tumours or a larger growth within the liver, but the disease has not spread to other parts of the body. At this stage, having surgery to cut the tumour out completely or having a liver transplant is usually not possible.
The usual treatment for intermediate liver cancer is a targeted hospital procedure known as transarterial chemoembolisation (TACE). During TACE, a doctor passes a small tube into the blood vessels feeding the tumour. They inject anti-cancer medication directly into the growth and then block the blood supply. This starves the tumour while keeping the medicine concentrated in the liver. While TACE can help shrink or control tumours, doctors are looking for ways to improve how well it works and keep tumours under control for longer.
This trial is testing whether adding an immunotherapy medicine called nivolumab can boost the benefits of TACE. Unlike chemotherapy, nivolumab does not attack cancer cells directly. Instead, it helps 'unmask' cancer cells so that the body's natural immune system can find and destroy them. Researchers believe that damaging the tumour with TACE while also stimulating the immune system with nivolumab might work better together than either treatment alone.
By taking part, participants help doctors learn whether this combination is safe and more effective than standard treatment. If the combination proves successful, it could become a standard treatment option for people with intermediate-stage liver cancer across the UK.
Key takeaways
- Tests adding the immunotherapy drug nivolumab to standard chemoembolisation (TACE).
- Designed for people with intermediate liver cancer that cannot be removed by surgery.
- Participants are randomly assigned to receive either standard TACE alone or TACE with nivolumab.
- Requires a liver tumour biopsy before treatment begins.
- Taking part is voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to adults and young people aged 16 and over who have intermediate-stage primary liver cancer that can be clearly measured on a CT or MRI scan. It is meant for people who are not able to have surgery to cut the cancer out or have a liver transplant, but who are still active and well enough to carry out everyday activities.
To make sure taking part is safe, your liver and kidneys must be functioning reasonably well, and your routine blood counts must be within safe limits. All participants must also have a small tissue sample (a biopsy) taken from their liver tumour before joining so doctors can confirm the exact diagnosis and study the cells.
You may not be eligible if you have an active autoimmune condition, such as lupus, rheumatoid arthritis, or inflammatory bowel disease, or if you take high doses of steroid medications. This is because nivolumab activates the immune system and could make autoimmune conditions worse. Participants must also agree to use reliable contraception during and after the trial to avoid pregnancy.
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 have been diagnosed with intermediate-stage primary liver cancer (hepatocellular carcinoma).
- My doctor has confirmed my cancer cannot be treated with surgery or a liver transplant.
- I am aged 16 or older.
- I am well enough to walk and look after myself day to day.
- I do not have an active autoimmune illness requiring strong steroid medicine.
- I am willing to have a liver biopsy and use reliable contraception.
What does participation involve?
Taking part in this study involves regular visits to the hospital for treatment, blood tests, and scans. All participants receive standard TACE treatment, which is carried out as a planned procedure. Depending on which group you are placed into, you may also receive nivolumab, given through a drip into a vein every few weeks. Before starting, you will have a liver biopsy and health checks to confirm you are safe to join. During the study, your medical team will perform regular physical checks, blood tests, and CT or MRI scans every few months to see how your tumour is responding. Your active treatment and follow-up checks may continue for several months to a couple of years, depending on your overall health and how your cancer responds.
Potential risks and benefits
Locations (26)
- THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUSTUnverifiedBEBINGTON WIRRAL, England
- ROYAL LIVERPOOL AND BROADGREEN UNIVERSITY HOSPITALS NHS FOUNDATION TRUSTUnverifiedLIVERPOOL, England
- AINTREE UNIVERSITY HOSPITAL NHS FOUNDATION TRUSTUnverifiedLIVERPOOL, England
- KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUSTUnverifiedLONDON, England
- UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUSTUnverifiedBIRMINGHAM, England
- NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUSTUnverifiedNOTTINGHAM, England
- UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUSTUnverifiedSOUTHAMPTON, England
- UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUSTUnverifiedBRISTOL, England
- THE CHRISTIE NHS FOUNDATION TRUSTUnverifiedMANCHESTER, England
- THE ROYAL MARSDEN NHS FOUNDATION TRUSTUnverifiedLONDON, England
- CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUSTUnverifiedCAMBRIDGE, England
- ROYAL SURREY COUNTY HOSPITAL NHS FOUNDATION TRUSTUnverifiedSURREY, England
Common questions
What is nivolumab and how does it work?
Nivolumab is an immunotherapy medicine that helps your body's own immune system recognise and attack cancer cells.
Will I definitely receive nivolumab if I take part?
No. A computer puts participants into one of two treatment groups by chance to ensure a fair test between the new combination and standard care.
Do I have to have a liver biopsy?
Yes. A biopsy is required before starting the study so the team can confirm the diagnosis and study the tumour tissue.
How often will I need to go to the hospital?
You will usually visit every few weeks for treatments, blood checks, and regular scans, depending on your treatment schedule.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without giving a reason, and you will continue to receive the standard NHS care.
How to find out more
Brenda Hall
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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