A trial of radioembolisation with TheraSphere before sorafenib for liver cancer (STOP-HCC)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Liver cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at a treatment called radioembolisation before starting a drug called sorafenib for liver cancer. It is for people who have a type of liver cancer called hepatocellular carcinoma that can’t be removed with surgery.

More about this trial

If hepatocellular carcinoma (HCC) can’t be removed with surgery, or a type of treatment called chemo embolisation, Open a glossary item doctors usually treat it with a drug called sorafenib. But researchers are looking for ways to improve treatment. In this trial they are looking at a treatment called radioembolisation.

TheraSphere is one product that is used for radioembolisation Open a glossary item . It uses millions of tiny glass radioactive beads. The beads are put directly into the liver and they give off radiation for a few weeks. The radiation damages the cancer cells and the cancer’s blood supply. As the beads only give off radiation to a small area, they cause little damage to the surrounding healthy tissue.

The researchers think that having radioembolisation before starting sorafenib may be better at extending life than having sorafenib alone. In this trial, half the people will have radioembolisation before they start sorafenib and the other half will only have sorafenib.

The aims of this trial are to find out

If having radioembolisation before starting sorafenib is better at extending life than having sorafenib alone for HCC
How the cancer responds to treatment
More about the side effects
How having radioembolisation before sorafenib affects quality of life

Who can enter

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) that can’t be removed with surgery
Your cancer can be measured on a CT scan or MRI scan
Your doctor has decided that the best treatment for you is sorafenib
Your liver is working reasonably well (Child-Pugh score of no more than 7 points). Your doctor can tell you this
You are able to have a fine tube (catheter) put into a blood vessel in your groin as part of the radioembolisation treatment
You have satisfactory blood test results
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are willing to use a reliable contraception during treatment and for at least a month afterwards if there is any chance 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 to another part of your body apart from your lungs and the lymph nodes in your tummy (abdomen) or around your liver and these are no more than 2cm across in size
You are able to have treatment with the aim to cure your liver cancer such as radiofrequency ablation or surgery such as a liver transplant
Your cancer takes up 70% or more of your liver or 50% or more and your blood test results show there a low level of a protein made in the liver called albumin (your doctor can tell you this)
You have a blockage in the main vein into your liver (the portal vein)
You had surgery to remove part of your liver in the last 2 months
You have had any anti cancer drugs for your liver cancer
You have had radiotherapy to your liver or tummy (abdomen)
You have already had radioembolisation to your liver
You have had treatment called embolisation or chemo embolisation in the last 2 months if the area of cancer treated was in the area of the liver that the trial team want to treat now
You have taken an experimental drug as part of a clinical trial in the last month
You are still having side effects from any earlier treatment
You have had another cancer in the last 5 years. You may be able to join if you had a cancer that was treated successfully more than 5 years ago
You have certain heart problems or problems with your digestive system (the trial team can advise you about this)
You have a build up of fluid around your tummy (ascites ) unless it is a very small amount that is only seen on a scan
You have HIV. You might be able to join if your HIV is well managed, well controlled and your viral load can't be detected
You have breathing problems
You have a blockage or problem where the tube from the pancreas and bile duct come together (your doctor can confirm this)
You have any other medical condition or mental health problem that the trial team thinks could affect you taking part
You are taking certain medications that the trial team thinks could affect you taking part
You are allergic to any of the drugs or the contrast medium used in the trial
You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The trial team need 520 people to join.

It is a randomised trial. The people taking part will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

• People in one group have sorafenib only
• People in the other group have sorafenib and radioembolisation Open a glossary item

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People in both groups take 2 sorafenib tablets twice a day. As long as you don’t have bad side effects, you can carry on having this treatment for as long as it helps you.

If you are the group having radioembolisation, you start by having one or two treatments. The doctor makes a small cut in your groin and passes a fine tube (a catheter) from there up into blood vessels in your liver. The doctor then injects the tiny glass beads through the catheter and they get stuck in the small blood vessels in and around the cancer. You may have more radioembolisation treatment if your cancer continues to grow or new areas of cancer form.

Before you have radioembolisation, you will have a test to look at the blood supply inside your liver (angiography). This is to reduce the risk of the glass beads affecting any other areas of your body. The doctor will inject a dye that shows up the blood vessels on a digital X-ray. Very rarely, people cannot have radioembolisation because they have too much blood flowing from the liver to the lungs, stomach and intestines.

Everybody taking part will be asked to fill out a questionnaire before starting treatment, every 2 months during treatment and after finishing treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You see the doctor and have some tests before taking part in the trial. These include

Physical examination
CT scan or MRI scan of your chest, tummy (abdomen) and pelvis
Tests to see how well your liver is working (Child-Pugh score tests)
Blood tests

During treatment you see the doctor every 2 months for

A physical examination
Blood tests
CT scan or MRI scan

When you finish treatment, you see the trial team again and have some of the tests you had when you started the trial. After that they will check how you are every 2 months at routine hospital visits.

Side effects

The most common side effects of radioembolisation include

Tiredness (fatigue)
Tummy (abdominal) pain or bleeding in your tummy
Feeling sick
High temperature (fever)
Changes in your liver function tests

There is a small risk that the tiny glass beads may not reach or stay in your liver. They can then affect other parts of the body such as the tummy (abdomen) or lungs. This is very rare, but if it happens, it could cause

Ulcers in the stomach or intestine
Fluid retention or scarring of the lungs

There is also a small risk of having an allergic reaction to the dye used to test the liver’s blood supply, and a small risk of long term damage to healthy parts of the liver.

The most common side effects of sorafenib include