A trial comparing treatment for primary liver cancer that cannot be removed with surgery (TACE)

Please note this trial is no longer recruiting patients.

This trial is comparing 2 treatments called chemoembolisation and embolisation to see which treatment is better at treating primary liver cancer (hepatocellular carcinoma). Primary liver cancer is cancer that started in the liver, and is different to cancer that has spread to the liver from somewhere else in the body. Embolisation is a way of cutting off the cancer’s main blood supply. The doctor injects something that blocks the blood vessels to the area of the liver containing the cancer cells. This reduces the supply of oxygen and food to the cancer, and may cause it to shrink.

Chemoembolisation is similar to embolisation. But the doctors inject a chemotherapy drug called cisplatin a few hours before they inject the substance that blocks the blood vessel.

Doctors do not know whether chemoembolisation works better than embolisation alone. The aim of this trial is to compare these two treatments to find out which works best. And to find out more about the side effects.

Please note, this trial is for cancer that started in the liver (primary liver cancer), not for cancer that started somewhere else in the body and has spread to the liver (secondary liver cancer).

Recruitment

Start 01/12/2003

End 12/01/2010

Phase

Phase 2

Who can enter

You can enter this trial if you

Have primary liver cancer (hepatic cell carcinoma, or HCC) that is contained within the liver, but cannot be removed with an operation
Have either one single tumour that is more than 3cm, or have more than one tumour in your liver
Have satisfactory blood test results
Are well enough to take part (performance status 1 or 2)
Are at least 16 years old
Are willing to use reliable contraception throughout the trial and for 3 months after treatment, if there is a chance that you could become pregnant

You cannot enter this trial if you

Have liver cancer that has spread outside the liver or to another part of the body (metastasised)
Have already had treatment for your liver cancer
Have very severe liver cirrhosis (Child-Pugh grade C)
Have an infection, or have problems with bleeding
Have problems with your liver which have damaged your brain or nervous system (hepatic encephalopathy)
Have a build up of fluid in your tummy (ascites) which is still there after treatment with water tablets (diuretics)
Have a blockage in one of the major blood vessels supplying blood to the liver (hepatic artery or portal vein)
Are allergic to contrast medium
Have had any other cancer in the past, and the doctors think this may make it difficult to assess how well you respond to this treatment
Have poor liver or kidney function
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial and will recruit 80 patients to start with. If it goes well, the doctors will recruit a further 242 patients in a phase 3 trial.

This is a randomised trial. The people taking part are put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1 you will have embolisation. You go to the X-ray department to have this treatment. First you have a local anaesthetic into your groin. The doctor puts a thin tube (a catheter) into the artery in your groin (femoral artery) and threads it up to the hepatic artery that feeds the liver. Once they are sure that the catheter is in the right place, the doctors will inject beads directly into your liver. The beads block the blood flow to the cancer. The doctors will then remove the tube. The beads dissolve after some time, so you have embolisation up to 3 times, 3 weeks apart.

If you are in group 2 you will have chemoembolisation. You will have a tube put into your groin in the same way as the people in group 1. Once the doctors are sure that the catheter is in the right place, they will inject the chemotherapy drug cisplatin into the tube in your groin, so that the chemotherapy goes directly to the cancer. You will go back to the ward for about 4 - 6 hours.

You will then return to the X-ray department and have embolisation. The doctors will inject beads directly into your liver. The beads block the blood flow to the cancer. The doctors will then remove the tube. You will have chemoembolisation up to 3 times, 3 weeks apart.

Everyone taking part will be asked to fill in a questionnaire before the treatment, several weeks after the last treatment, and 3 and 6 months after treatment. The questionnaire will ask you how you are feeling and what side effects you are having. It is called a quality of life questionnaire. You don’t have to fill this in if you don’t want to.

Hospital visits

You will have some tests before you take part in the trial. The tests include a CT scan and blood tests. You may also have an MRI scan.

You will go to the hospital on the day of each treatment, or the evening before. Everyone taking part will stay in hospital the night after the treatment, and you will spend up to 2 days in hospital.

You will have blood tests before each treatment. After all 3 treatments, you will have another CT scan and blood tests. You will continue to have blood tests and see the doctors. How often you see the doctors depends on normal practice at your hospital.

Side effects

The dose of cisplatin in this trial is low, because it is injected directly into the cancer. So you may not get many side effects from this drug. The most common side effects of cisplatin are