A trial of trastuzumab deruxtecan for people with oesophageal, stomach or gastro oesophageal junction cancer (DECIPHER)
Cancer type:
Status:
Phase:
This trial is looking at trastuzumab deruxtecan after surgery. It’s for people with cancer of the:
- stomach
- food pipe (oesophagus)
- area where the stomach joins the food pipe (gastro oesophageal junction)
And both of the following:
- a large amount of the
HER2 
protein on the cancer cells - this is called HER2 positive cancer - small amounts of cancer DNA in the bloodstream after surgery - this is called
circulating tumour DNA or ctDNA
This trial is for people with cancer that has not spread to another part of the body. And it has been completely removed with surgery.
More about this trial
Surgery with chemotherapy is a common treatment for people with certain types of stomach, oesophageal or gastro oesophageal junction cancer.
You might have FLOT chemotherapy before and after surgery if you have this type of cancer and it has not spread.
Research shows that chemotherapy after surgery is less likely to work well in some people. There is some evidence that the cancer is more likely to come back if there is ctDNA in the bloodstream after chemotherapy and surgery.
Doctors would like to improve treatment for people in this situation. In this trial the team are looking at treating cancer. They think that a called trastuzumab deruxtecan could help but they don’t know for sure. They are doing this trial to try and find out.
Trastuzumab deruxtecan is a combination of the targeted cancer drug trastuzumab (also known as Herceptin) and a drug called deruxtecan or DXd.
Trastuzumab attaches to the HER2 receptor and can stop the cancer cells from growing. When it attaches to the HER2, it allows the deruxtecan to go into the cancer cell. Inside the cell, deruxtecan becomes active and kills the cancer cell.
Everyone taking part has trastuzumab deruxtecan after surgery.
The main aims of the trial are to find out:
- how well trastuzumab deruxtecan after surgery works
- what the side effects are
- how treatment affects
quality of life
Who can enter
The following bullet points are a summary of 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 you have one of the following:
- stage 1, 2 or 3
adenocarcinoma of the stomach - adenocarcinoma of the
gastro oesophageal junction that has not spread to another part of the body - adenocarcinoma of the lower food pipe (oesophagus) with the middle of the cancer being 1 to 5cm above the gastro oesophageal junction. And the cancer has not spread to another part of the body. Your doctor will know more.
And all of the following apply. You:
- have large amounts of
HER2 protein on the cancer cells - have
circulating tumour DNA (ctDNA) after surgery - had at least 6 weeks of
chemotherapy before surgery - have had all the cancer removed with surgery along with a surrounding border of tissue that was cancer free
- have recovered from your operation to remove the cancer
- are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- have satisfactory heart test results after an echocardiogram (ECHO) or
MUGA scan within the 28 days before starting treatment - have satisfactory blood test results
- are willing to use reliable contraception during the trial and for a period afterwards if there is any chance that you or your partner could become pregnant
- will not store sperm while having treatment and for a period afterwards
- will not donate eggs, or use your own eggs for fertility treatment, while taking part in the trial and for a period afterwards
- will not have a
live vaccine in the 30 days after your last dose of trastuzumab deruxtecan - are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have had a
CT scan after surgery which showed that cancer has spread to another part of the body - have had treatment with trastuzumab (Herceptin) or any other drug that targets the HER2 protein
- have had another
primary cancer in the last 3 years. You might be able to take part if you have had treatment to completely remove a non melanoma skin cancer , or you have had successful treatment for a very early (in situ) cancer or for another solid tumour . - have side effects from other cancer treatments unless they are mild or have gone back to normal for you. You might be able to take part if you have hair loss. And you might be able to take part if you still have certain moderate side effects from treatment, such as tiredness. Your doctor will know more.
Medical conditions
You cannot join this trial if any of these apply. You:
- have another serious physical or mental illness which is not well controlled, such as an active or ongoing infection
- have serious
heart problems , such as a heart attack in the last 6 months. Your doctor will know more. - have had scarring of the lungs called interstitial lung disease or
pneumonitis which have not been caused by infection in the past. Or you have, or may have, interstitial lung disease or pneumonitis now. - have an
autoimmune condition that affects your lungs - have had one of your lungs removed (pneumonectomy)
- have any other serious
lung problems . Your doctor will know more. - have an uncontrolled infection which needs treatment into the bloodstream (intravenous treatment)
- have a collection of fluid around the lung, heart or elsewhere in the body that needs draining with a tube
- have a tube to drain fluid inside your
peritoneum called a peritoneal shunt - have an immunodeficiency disorder, meaning your immune system is not working as well as it should
- have HIV or active hepatitis B or active hepatitis C
- have any other medical conditions that the trial team think would make it more difficult for you to take part
Other
You cannot join this trial if any of these apply. You:
- are allergic to trastuzumab deruxtecan or anything it contains
- have had a serious allergic reaction to another
monoclonal antibody - have been involved in planning or organising the trial in some way
- have had a
live vaccine in the 30 days before your first dose of trastuzumab deruxtecan. Please note the current COVID-19 vaccines are not live. - are using drugs in a way that could be harmful and make it more difficult for you to take part
- have any other non medical (social) circumstances which would make it difficult for you to take part. Your doctor can explain more.
- are pregnant, breastfeeding or planning a pregnancy
Trial design
This is a phase 2 trial. The researchers would like 25 people to take part.
Everyone has trastuzumab deruxtecan as . You start treatment around 8 to 12 weeks after surgery. This gives you time to recover from your operation.
Each cycle takes 21 days. You have treatment on day 1 of the cycle.
You have up to 8 cycles of treatment on the trial. This means around 6 months of treatment, as long as it’s working, and the side effects are not too bad.
You stop treatment on the trial if your cancer comes back. Your doctor will talk with you about other treatment options if this happens.
Research samples
The team ask for a piece of the tissue sample (biopsy) from your surgery. They check that your cancer has the HER2 protein to make sure that trastuzumab deruxtecan is a suitable treatment for you.
If your cancer comes back, the team ask for a tissue sample. They use the sample to look at possible reasons why the treatment was not successful. This is optional. You can say no and still take part in the main trial.
The researchers also use the tissue samples to look at changes in the cancer cells. They want to find out which people are more likely to benefit from trastuzumab deruxtecan than others.
You have blood tests as part of the trial. These are to look for ctDNA in the bloodstream and what effect the treatment is having on your body.
You have research blood tests:
- before starting treatment on the trial
- before cycle of treatment 1,2,3,4 and 5
- around a week after your final cycle of treatment has finished
- every 3 months for the first year after treatment
- every 6 months until 2 years after treatment
Quality of life questionnaires
You fill in quality of life questionnaires before, during and after treatment. This is to find out more about any side effects you’ve had, and how you are coping with day to day life.
You fill them in:
- before treatment
- around day 1 of each treatment cycle
- every 3 months for up to 2 years after treatment
- if your cancer comes back
Hospital visits
You see the doctor and have some tests before taking part. These include:
- a
physical examination - a CT scan
- blood tests
- a pregnancy test - if there is any chance you could become pregnant
- a urine test
lung function tests - heart trace (
ECG ) - a heart scan - either an ECHO or
MUGA - eye test
You have trastuzumab deruxtecan as a drip into the bloodstream. It takes less than an hour each time. You have treatment as an in the hospital.
You see the trial team at the hospital around once every 21 days. This is so they can check how you are. You have some tests at these visits before you have your treatment. These include:
- blood tests
- a physical examination
- a pregnancy test - if there is any chance you could become pregnant
You have an extra visit to hospital a week after your first dose of trastuzumab deruxtecan. You see the trial team and have some blood tests. This is to check if you have had any treatment side effects in this first week.
At the end of treatment, you have a hospital appointment about a week after your last treatment cycle. This is called your end of treatment visit. You have some tests at this visit. These are:
- blood tests
- a physical examination
- eye tests
Follow up
The trial team monitor how you are doing for about 2 years after you finish treatment. They see how you are feeling and look for any signs of your cancer coming back. This is called follow up.
You see the trial team every 3 months until the end of the 2 years.
At these visits you have:
- a CT scan
- blood tests
- a physical examination
You might have a pregnancy test if needed at some of these follow up visits.
The trial ends after 2 years.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of trastuzumab deruxtecan are:
- feeling or being sick
- tiredness (fatigue)
- hair loss
- diarrhoea or constipation
- reduced appetite
- decreased red blood cells, white blood cells and platelets which may cause tiredness, increased risk of infection or bleeding
- coughing
- tummy (abdominal pain)
- headaches
- increased liver
enzymes - sores in and around your mouth
- difficulty breathing
- severe nosebleeds
- low potassium levels in the blood
We have more information about trastuzumab deruxtecan including possible side effects.
Location
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
Dr Elizabeth Smyth
Supported by
University of Southampton
Southampton Clinical Trials Unit
AstraZeneca
Other information
You can watch a video about the trial here. It has been made by the trial team.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
