A trial of sorafenib in combination with 2 other treatments for liver cancer (SORAMIC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called sorafenib in combination with selective internal radiation therapy or radiofrequency ablation to treat liver cancer. The trial is open to people with a type of liver cancer called hepatocellular carcinoma (HCC) that can’t be removed by surgery. This is an international trial and in the UK treatment will be either sorafenib in combination with selective internal radiation therapy (SIRT) or sorafenib alone.
More about this trial
If you have large areas of cancer in your liver or the cancer has spread to another part of your body this is called 
. The for this is sorafenib.
Sorafenib is a type of biological therapy. It is a cancer growth blocker. Sorafenib also works by blocking the growth of new blood vessels which the cancer needs to grow.
Selective internal radiation therapy (SIRT) is a type of treatment called radioembolisation. It uses small beads (sometimes called microspheres) to reduce the cancer. The beads are put into the main blood vessel (hepatic artery) that carries blood to the liver. The beads give off . This helps to kill off the cancer cells.
The researchers think that sorafenib combined with SIRT may be better than having sorafenib only. Internationally the researchers will also look at whether giving sorafenib after local ablation therapy is a better treatment.
The team are also doing a sub study, called a diagnostic study, to find out if a or an is best to help decide if you should be in the group that has local ablation or the group that has SIRT and sorafenib or sorafenib only.
The main aims of this trial are to find
- If the combination of SIRT and sorafenib is better than sorafenib alone
- If an MRI scan is just as good or better than a CT scan to help decide to which study group you belong
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
- Your liver is working reasonably well (the trial team will be able to tell you this)
- You have satisfactory blood test results
- You are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
- You are between 18 and 85 years old
You cannot join this trial if any of these apply. You
- Have liver cancer that has spread to another part of your body apart from the
lymph nodes , bones or adrenal glands - Have cancer in more than 70% of your liver (the trial doctor can tell you this)
- Have had another cancer in the past 5 years apart from
carcinoma in situ of the skin or cervix - Have an infection that isn’t controlled by medications
- Have a build up of fluid in the abdomen (ascites) that isn’t controlled by treatment
- Have had certain types of surgery done (the trial team can advise you about this)
- Have certain problems with your heart (the trial team can advise you about this)
- Have high blood pressure that isn’t controlled by medication
- Have had blood clots in the past 6 months
- Have had bleeding in your
digestive system within 30 days of agreeing to take part in the trial - Have had bleeding from swollen veins (varices) near the lining of the food pipe (oesophagus) that hasn’t been controlled by treatment
- Have had an organ transplant
- Have HIV
- Have a problem with your
immune system - Have an
autoimmune disease , such as rheumatoid arthritis, and are taking drugs that affect how your immune system works - Have any other medical or mental health problem that the trial team think could affect you taking part in this trial
- Are having treatment, or finished treatment, as part of another clinical trial within 30 days of agreeing to take part in this trial
- Are unable to have any of the drugs used in this trial
- Are pregnant or breastfeeding
Trial design
This is an international phase 2 trial. The trial team need 665 people to join.
There are 2 parts to this trial. The 1st part is the diagnostic part. The 2nd part is the treatment part.
In the diagnostic part everyone will have a CT scan and MRI scan to find out how far your cancer has developed and if it has spread to other areas of the body (metastases). Your doctor will explain to you the results of the scans. Depending on the results your doctor will tell you if you are able to go on to the treatment part.
In the UK the treatment will be with SIRT and sorafenib. In other countries there will be the option of local ablation. This involves using treatments such as radiofrequency ablation and microwave ablation.
The 2nd part is randomised. You are put into 1 of 2 groups by a computer. Neither you nor your doctor can choose which group you are in.
- People in one group have SIRT followed by sorafenib
- People in the other group have sorafenib only
You can have up to 2 treatments within 4 to 6 weeks. A 3rd treatment might be considered if your doctor believes it is necessary.
Before you have SIRT, you will have a test to look at the blood supply inside your liver. This is to reduce the risk of the microspheres affecting any other areas of your body. The doctor will inject a dye that shows up the blood supply to the liver. Very rarely, people cannot have SIRT because they have too much blood flowing from the liver to another organ such as the lungs. If you can’t have SIRT because of this, you will still have sorafenib as part of the trial.
You take sorafenib tablets twice a day.
The trial team will ask you to fill out a questionnaire
- Before you start treatment
- Every 2 months
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life questionnaire.
If you agree to take part in this study, the researchers will ask for a sample of your cancer when you had a or have a biopsy as part of your treatment. They will also ask for some extra blood samples. The researchers will use these samples to find out more about liver cancer. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.
Hospital visits
You see the doctor to have some test before taking part. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - CT scan (if not done in the past 4 weeks)
- MRI scan
When you have SIRT, you will be in hospital for 3 days. Two weeks after each SIRT treatment you have an MRI scan.
While taking sorafenib you see the doctor every 2 months for at least 2 years to have blood tests and to see how you are.
Your doctor will then tell you how often they want to see you.
Side effects
The most common side effects of sorafenib include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Diarrhoea or constipation
- Feeling weak
- Feeling tired (fatigue)
- Pain in the mouth, tummy (abdomen), bone, joints and where the cancer is
- Headache
- High blood pressure
- Sore, red palms of your hand and soles of your feet (hand- foot syndrome)
- A rash, or red, dry itchy skin
- Loss of appetite
- Weight loss
- High temperature (fever)
- Hair loss
We have more information about sorafenib.
The most common side effects of SIRT include
- High temperature (fever)
- Changes to the way your liver works
- Mild pain in the tummy (abdomen)
- Feeling or being sick
- Diarrhoea
The trial doctor will tell you about the possible side effects of each treatment before you agree to take part in the trial.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Dan Palmer
Supported by
Bayer Pharma AG
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sirtex
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
