TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma
This study is exploring a new treatment approach for certain types of stomach (gastric) and food pipe (oesophageal) cancer that can be removed by surgery. It aims to see if combining standard chemotherapy (FLOT) with an immunotherapy drug called durvalumab, given both before and after surgery, can lead to better results for patients. The goal is to improve how well the treatment works and simplify the process for patients, potentially making it easier to complete all necessary treatment steps. Researchers hope this approach could offer a new, more effective way to cure these cancers, building on promising early findings from similar studies.
At a glance
What is this study about?
This study is looking into a new way to treat specific types of stomach cancer or cancer where the food pipe joins the stomach (oesophagogastric junction). These cancers are currently serious, and doctors are always searching for better treatments. The study focuses on cancers that are advanced but can still be removed by surgery. At the moment, people usually get chemotherapy before surgery, and sometimes more treatment afterwards.
This new approach combines standard chemotherapy with a drug called durvalumab. Durvalumab is an immunotherapy, which means it helps your body's own immune system fight cancer. The researchers want to give both these treatments *before* surgery, and then continue with durvalumab *after* surgery. The idea behind giving most of the treatment before surgery is to make the cancer smaller and easier to remove, and potentially kill more cancer cells early on. It also helps patients complete their treatment more reliably.
By moving these powerful treatments to earlier in the journey, the study hopes to achieve a 'deeper response,' meaning more of the cancer cells are destroyed. This could lead to better chances of recovery and a lower risk of the cancer coming back. The study will provide important information to help doctors decide on the best future treatments for these types of cancer, aiming for improved long-term outcomes for patients.
Key takeaways
- This study is for certain stomach or food pipe cancers that can be removed by surgery.
- It combines chemotherapy and immunotherapy (durvalumab) before and after surgery.
- The aim is to improve treatment effectiveness and make it easier for patients.
- You need to meet specific health criteria to be eligible.
- Participation involves regular hospital visits for treatment and check-ups.
- You can stop participating at any time.
Who may be eligible?
To join this study, people need to be at least 18 years old and have a specific type of stomach or food pipe cancer that doctors believe can be removed with surgery. Your doctors will need to check your general health, including your blood counts, liver, and kidney function, to make sure you are well enough for the treatments involved. They will also look at a specific marker on your cancer called PD-L1; you can still join regardless of what your PD-L1 status is.
You should also be able to visit the hospital for treatments and check-ups during the study period. If you are a woman who could become pregnant, you would need to agree to use effective contraception during and for a period after the study treatment. Basically, the medical team will make sure you meet several health requirements to ensure it's safe for you to take part.
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 stomach or food pipe cancer that doctors say can be fully removed by surgery?
- Are you generally healthy enough for strong treatments, including good blood counts, liver, and kidney function?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- If you are a woman who could get pregnant, are you willing to use effective contraception during and after treatment?
What does participation involve?
If you decide to take part, you'll first have some tests to confirm you're suitable. The treatment plan involves several stages. You will receive chemotherapy alongside durvalumab for up to four months (eight 2-week chemotherapy cycles and four 4-week durvalumab cycles). After this initial treatment, you'll have surgery to remove the cancer, typically 1 to 2 months later. Following your surgery, you will then receive durvalumab alone for up to 10 more cycles, which means you could be on this part of the treatment for up to 10 months. You will have regular appointments and tests throughout this period and during follow-up to monitor your health and the treatment's effects. The total duration of active treatment and follow-up will depend on your individual response and how many durvalumab cycles you receive after surgery.
Potential risks and benefits
Locations (29)
- Charité BerlinVerified postcodeBerlin, Germany
- Vivantes Klinikum NeuköllnVerified postcodeBerlin, Germany
- Universitätsklinikum KölnVerified postcodeCologne, Germany
- Klinikum Essen MitteVerified postcodeEssen, Germany
- Krankenhaus NordwestVerified postcodeFrankfurt am Main, Germany
- Universitätsmedizin GöttingenVerified postcodeGöttingen, Germany
- Universitätsklinikum Halle (Saale)Verified postcodeHalle, Germany
- HOPE Hamburg EppendorfVerified postcodeHamburg, Germany
- UKE HamburgVerified postcodeHamburg, Germany
- NCT HeidelbergVerified postcodeHeidelberg, Germany
- Marien Hospital HerneVerified postcodeHerne, Germany
- Universitätsklinikum LeipzigVerified postcodeLeipzig, Germany
Common questions
What is immunotherapy?
Immunotherapy is a type of treatment that helps your body's own immune system find and fight cancer cells more effectively.
What is durvalumab?
Durvalumab is a specific immunotherapy drug that will be used in this study, typically given through a drip.
What does 'resectable' mean?
'Resectable' means that your doctors believe the cancer can be completely removed by surgery.
Will I still have surgery if I join this study?
Yes, if you join, surgery to remove the cancer is still a key part of your treatment plan, typically after the initial chemotherapy and immunotherapy.
How long will the treatment last?
The pre-surgery treatment takes up to 4 months, followed by surgery, and then up to 10 months of post-surgery immunotherapy. So, the main treatment phases could last over a year.
How to find out more
Thorsten Götze, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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