Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
This study (DECIPHER) is a UK trial for people with stomach or food pipe (gastro-oesophageal) cancer that has a specific protein called HER2. Participants would have already had chemotherapy and surgery. The study is for those who still have tiny, invisible traces of cancer DNA in their blood, which suggests the cancer might return. Instead of standard chemotherapy after surgery, participants will receive a new drug, trastuzumab deruxtecan (Enhertu). This drug targets and destroys HER2-positive cancer cells. The main goal is to see if this new treatment can reduce these traces of cancer and stop the cancer from coming back. About 25 patients will take part, and they will be followed for up to two years to see how well the treatment works.
At a glance
What is this study about?
When people are diagnosed with stomach or food pipe cancer, they usually have chemotherapy before surgery, and then more chemotherapy afterwards. However, even with this treatment, the cancer still comes back for many people.
Doctors can now look for tiny bits of cancer DNA in the blood, called "circulating tumour DNA" (ctDNA). If this ctDNA is found after surgery and chemotherapy, it means there are still microscopic cancer cells in the body that can't be seen on scans. This often means the cancer is more likely to return.
This study, called DECIPHER, is for people whose cancer cells have a specific protein called HER2. This protein can make cancer grow faster. The study aims to use a new drug called trastuzumab deruxtecan (also known as Enhertu) for patients who are HER2-positive and who still have ctDNA in their blood after their initial treatment. This drug works by attaching to the HER2 protein on cancer cells and killing them. The idea is that treating these microscopic cancer cells with trastuzumab deruxtecan early on, instead of the usual chemotherapy, might stop the cancer from coming back. This is a Phase II trial, meaning it's an early-stage study looking at how effective the treatment is.
Key takeaways
- This study is for people with HER2-positive stomach or food pipe cancer.
- It's for those who have tiny traces of cancer DNA in their blood after chemotherapy and surgery.
- The study uses a new drug, trastuzumab deruxtecan, to try and stop the cancer from coming back.
- About 25 patients will take part across the UK.
- Participants will receive the drug for about 6 months and be followed for up to 2 years.
- The aim is to treat any hidden, microscopic cancer cells.
Who may be eligible?
To be considered for this study, you would need to have been diagnosed with stomach or food pipe cancer (specifically, a type called adenocarcinoma) and have already had chemotherapy before surgery, followed by surgery where all visible cancer was removed.
Your cancer cells must also show a specific protein called HER2. After your surgery, doctors will check your blood for tiny traces of cancer DNA (ctDNA), and you would need to be positive for this to join the study. You must also be at least 18 years old.
There are also some health checks you would need to pass to make sure the treatment is safe for you, such as having good general health, a healthy heart, and normal blood test results for your liver and blood counts. You also shouldn't have been treated with any HER2-targeted drugs before.
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.
- I have stomach or food pipe cancer (adenocarcinoma).
- My cancer is HER2 positive.
- I have already had chemotherapy before surgery, and then had surgery to remove the cancer.
- After my surgery and chemotherapy, a blood test showed tiny traces of cancer DNA (ctDNA).
- I am at least 18 years old.
- I have not had any HER2-targeted drugs before.
What does participation involve?
If you join the study, you would receive the study drug, trastuzumab deruxtecan, every 21 days for a total of 8 cycles. This means you would have an infusion about every three weeks. Before each treatment, you would likely have appointments for blood tests and other checks to make sure you're well enough for treatment.
After your treatment cycles are complete, doctors will continue to follow your health and monitor your condition for up to two years. This means you would have regular check-ups and scans to see how you're responding and if the cancer has returned. The whole process of treatment and follow-up could last up to two years.
Potential risks and benefits
Locations (14)
- Royal Surrey NHS Foundation Trust, Royal Surrey County HospitalVerified postcodeGuildford, United Kingdom· Not yet recruiting
- University Hospitals Coventry and Warwickshire, University Hospital CoventryVerified postcodeCoventry, United Kingdom· Recruiting
- Belfast Health and Social Care Trust, Belfast City HospitalVerified postcodeBelfast, United Kingdom· Recruiting
- Cambridge University Hospital NHS Foundation Trust, Addenbrookes HospitalVerified postcodeCambridge, United Kingdom· Recruiting
- University Hospitals of Derby and Burton NHS Foundation Trust, Royal Derby HospitalVerified postcodeDerby, United Kingdom· Recruiting
- NHS Tayside, Ninewells HospitalVerified postcodeDundee, United Kingdom· Recruiting
- Hull University Teaching Hospitals NHS Trust, Castel Hill HospitalVerified postcodeHull, United Kingdom· Recruiting
- Leeds Teaching Hospitals NHS Trust, St James's University HospitalVerified postcodeLeeds, United Kingdom· Recruiting
- University College London Hospitals NHS Foundation Trust, University College Hospital LondonVerified postcodeLondon, United Kingdom· Recruiting
- Guys & St Thomas NHS Foundation Trust, Guy's HospitalVerified postcodeLondon, United Kingdom· Recruiting
- The Christie NHS Foundation TrustVerified postcodeManchester, United Kingdom· Recruiting
- Oxford University Hospitals NHS Trust, Churchill HospitalVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What is HER2 positive cancer?
HER2 positive means your cancer cells have a lot of a specific protein on their surface. This protein can make cancer grow faster. Drugs that target HER2, like the one in this study, can help stop this growth.
What is ctDNA and why is it important?
ctDNA is tiny bits of cancer DNA found in your blood. If it's present after surgery and chemotherapy, it means there might still be very small amounts of cancer in your body that could cause the cancer to come back.
What is trastuzumab deruxtecan (Enhertu)?
It's a drug that specifically targets HER2-positive cancer cells and destroys them. It's already approved for some types of breast cancer in the UK and for stomach/food pipe cancer in other countries.
How long will the treatment last?
If you qualify for the study, you would receive 8 cycles of treatment, with each cycle lasting 21 days. This means the treatment period would be about six months. After that, you would be followed for up to two years.
Will I still get my usual treatment for cancer?
In this study, if you are eligible, you would receive trastuzumab deruxtecan instead of the standard chemotherapy you might normally receive after surgery. The study is comparing this new approach.
How to find out more
Elizabeth Smyth
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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