A trial of nivolumab and TACE or TAE for cancer of the liver (TACE 3)

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. 

• You have a type of liver cancer called hepatocellular carcinoma (HCC). 
• You have at least one area of cancer that can be measured on a CT scan  or MRI scan .
• You aren’t suitable to have surgery to remove the cancer or to have a liver transplant. 
• Your liver is working normally (Child-Pugh A).
• You have a satisfactory score on a scoring system which shows whether you can cope with TACE (HAP score A, B or C).
• You have satisfactory blood test results. 
• You are willing to have a new sample of tissue (biopsy ) taken before starting treatment if necessary.
• You are willing to use reliable contraception for at least 5 months after treatment if you are a woman or for 7 months if you are a man and there is any chance you or your partner could become pregnant. 
• You are well enough to carry out all your normal activities but might not be able to do heavy physical work (performance status of 0 or 1).
• You are at least 16 years old. 

Who can’t take part
You cannot join this trial if any of these apply. 

Cancer related
You:

• have liver cancer that has spread outside of the liver  
• have already had embolisation or radiotherapy for HCC
• can’t have liver embolisation for any reason, for example you have a shunt in the liver, abnormal blood flow in the liver or severe problems with the arteries in the liver 
• have mild, moderate or severe liver damage (Child-Pugh B or C)
• have a score that shows you won’t cope with chemoembolisation (HAP score D)
• can’t have treatment with a type of immunotherapy such as nivolumab that targets PD-1
• have had another cancer apart from those treated successfully with surgery, non melanoma skin cancer  or CIS of the cervix 
• have had an experimental treatment  

Medical conditions
You:

• aren’t as alert as usual due to liver failure, for example you are more drowsy or confused or you have difficulty thinking 
• have had a bleed in your stomach or food pipe (oesophagus) in the 4 weeks before joining the trial 
• have a blockage in the main artery or main vein in the liver 
• have a collection of fluid on the liver and treatment to get rid of it isn’t working 
• are allergic to the contrast dye  you have for some scans
• have a condition called interstitial lung disease
• have a serious infection or an active infection that needs treatment in the 7 days before joining the trial 
• have had major surgery in the 4 weeks before joining the trial 
• have hepatitis
• have symptoms of tuberculosis (TB) or had a test that shows you have TB but aren’t showing symptoms
• are having treatment to damp down the immune system such as steroids unless it is less than 10mg of prednisolone a day
• have an inflammatory disease of the gut including Chron’s disease and ulcerative colitis 
• have an active or suspected autoimmune condition  apart from type 1 diabetes, thyroid problems that are controlled by medications, pale white patches on the skin (vitiligo), hair loss or conditions that won’t come back again 
• have any other medical condition or mental health problem that means the trial team don’t think you will be suitable to take part in this trial

Other
You:

• have had a live vaccine  within 30 days before you start trial treatment
• are allergic to any of the drugs or their ingredients used in the trial
• are pregnant or breastfeeding