Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab
This study is for people with advanced oesophageal cancer. We're trying to find a faster way to know if a treatment called durvalumab is working. Durvalumab is a medicine that helps your body’s own immune system fight cancer. Currently, we use scans to see if treatments are effective, which can take months. This study will measure something called 'circulating tumour DNA' (ctDNA) in blood. We want to see if changes in this ctDNA can tell us much sooner if the treatment is helping. If it can, this means patients who aren't responding could switch to a different treatment faster, avoiding unnecessary side effects and time on a treatment that isn't working for them.
At a glance
What is this study about?
When people have cancer, doctors often use medicines that help their body's natural defense system, called the immune system, fight off cancer cells. These medicines, like durvalumab in this study, aim to give your immune system a boost against the disease. However, it can sometimes be hard to tell early on if these treatments are actually working for each individual. Currently, we usually rely on imaging tests, like CT scans, which means waiting several months to see if the cancer has shrunk or stopped growing.
This study is looking into a new and potentially much faster way to check if a treatment is effective. We will be measuring something called 'circulating tumour DNA,' or ctDNA, in your blood. Think of ctDNA as tiny bits of cancer cells' genetic material that can be found floating in your bloodstream. By taking blood samples regularly, we can track if the amount of this ctDNA changes after you start treatment.
The main idea is that if the treatment is working, the amount of ctDNA in your blood might go down quickly. If it's not working, the levels might stay the same or even go up. If we can see these changes sooner than with traditional scans, it means doctors could make decisions about your treatment much earlier. This would be a big step forward because it could help people switch therapies sooner if the first one isn't helping, saving valuable time and reducing the time you might spend dealing with side effects from a treatment that isn't right for you. This study focuses on people with advanced oesophageal cancer and will take place at Addenbrooke's Hospital in Cambridge.
Key takeaways
- The study aims to find a faster way to see if oesophageal cancer treatment is working.
- It uses a blood test (ctDNA) instead of just scans to check treatment response.
- The treatment is durvalumab, an immunotherapy that helps your immune system.
- This could help patients switch treatments sooner if needed, reducing side effects.
- The study involves about 19 patients at Addenbrooke's Hospital, Cambridge.
Who may be eligible?
This study is looking for around 19 adults, aged 18 or over, who have advanced oesophageal cancer. You must have already had at least one other type of standard cancer treatment.
Your general health needs to be good enough to take part in the study. This means having a predicted life expectancy of at least 3 months and being active enough to manage everyday tasks (doctors use a scale for this, and you'd need an 'ECOG score' of 0 or 1). Your blood tests and other organ functions also need to be within healthy limits. We also need to be able to measure your cancer on scans and, importantly, you'd need to have a part of the tumour that can be safely biopsied for extra research if you agree.
There are also some reasons why you might not be able to join. For example, if you are currently having other active cancer treatments (like chemotherapy or other immune therapies), or if you've recently had a lot of radiotherapy. Certain existing health conditions, especially autoimmune diseases (where your immune system mistakenly attacks your own body), might also prevent you from taking part, along with some recent symptoms from previous treatments.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Do you have advanced oesophageal cancer and have had at least one previous treatment?
- Is your general health good enough for a study, with a predicted life expectancy of at least 3 months?
- Do you have a tumour that can be measured and safely biopsied for research purposes?
- Are your blood tests and organ functions within healthy limits?
What does participation involve?
If you decide to take part in this study, you will receive the study drug, durvalumab, which is given as an infusion (through a drip). You will continue to receive this treatment until your cancer gets worse, or if you experience side effects that prevent you from continuing.
Throughout the study, you will have regular blood tests to check the levels of ctDNA, as well as routine checks of your overall health and any side effects. You'll also have regular scans, just as you would with standard care, to allow us to compare the ctDNA results with traditional ways of monitoring your cancer. The study will assess your tumour and immune response in detail. All of this will take place at Addenbrooke's Hospital in Cambridge. The study will continue until your cancer progresses or you stop treatment for other reasons.
Potential risks and benefits
Locations (1)
- Cambridge University Hospitals NHS Foundation TrustVerified postcodeCambridge, United Kingdom
Common questions
What is oesophageal cancer?
Oesophageal cancer is a cancer that starts in the gullet, which is the tube that carries food from your mouth to your stomach.
What is durvalumab?
Durvalumab is a type of medicine called immunotherapy. It helps your body's immune system fight cancer cells more effectively.
What is ctDNA?
ctDNA stands for 'circulating tumour DNA'. These are tiny fragments of DNA that come from cancer cells and can be found in your blood.
Will I get 'fake' treatment (a placebo) in this study?
No, all patients in this study will receive the active drug, durvalumab. There is no placebo group.
Where does the study take place?
This study is happening at a single location, Addenbrooke's Hospital in Cambridge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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