"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at GC33 for advanced liver cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called GC33 for a type of liver cancer called hepatocellular cancer (HCC) that has spread.
Doctors usually treat hepatocellular cancer with chemotherapy. But sometimes the cancer starts to grow again. When this happens it is often more difficult to treat.
In this trial doctors are looking at a drug called GC33. It is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins on the cells’ surface.
Doctors know that some liver cancer cells have a protein called GPC-3 on the surface. They are called GPC-3 positive. Your doctor will test your liver cancer to find out if it has this protein.
The aims of this trial are to find out
- How well the new drug GC33 works for GPC-3 positive hepatocellular cancer
- If GC33 works for GPC-3 negative hepatocellular cancer
- What the side effects are
Who can enter
You may be able to enter this trial if you
- Have liver cancer (hepatocellular cancer) that has spread and cannot be removed with surgery
- Have cancer that can be measured on CT scan
- Have satisfactory blood test results
- Have recovered from any recent surgery
- Have a sample of tissue that can be tested for GPC-3
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during treatment and for 3 months afterwards (for women) or 40 days afterwards (for men) if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have not had treatment that reaches the whole body (
systemic treatment) in the past
- Have a type of liver cancer called fibrolamellar HCC
- Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or carcinoma in situ of the bowel that was successfully treated at least 5 years ago
- Have cancer that has spread to your brain or spinal cord (
- Have an infection that needs treating except for hepatitis B or C
- Have had any sort of severe bleeding in the last 4 weeks
- Have had an organ transplant
- Need treatment other than the trial treatment for your cancer
- Have had treatment for your cancer in the last 2 weeks
- Still have side effects from previous treatment
- Have medical problems that are a cause for concern
- Are HIV positive
- Are known to be allergic to monoclonal antibodies
- Take drugs to thin the blood (anticoagulants), apart from a low dose of heparin or aspirin
- Are pregnant or breastfeeding
This trial will recruit about 171 people. If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. If no tissue sample is available, you will need to have a biopsy taken. This is to find out if your liver cancer is GPC-3 positive or not. Researchers will also take extra blood samples for research. Everyone taking part has either GC33 or dummy drug (
They will be put into treatment groups by a computer this is called randomisation. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
You have GC33 or the dummy drug (
You see the doctors and have some tests before you start treatment. The tests include
You have CT or MRI scans every 6 weeks for 18 weeks then every 8 weeks until you finish trial treatment.
You have heart traces (ECG’s) frequently while you are having trial treatment and again when you stop treatment.
On day 1 of each cycle and when you stop treatment you have
- Physical examination
- Blood tests
- Urine tests
The trial team will see you one month after stopping treatment for a blood test and then every 8 weeks to see how you are.
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.
Dr Phillip Harrison
Experimental Cancer Medicine Centre (ECMC)