A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer
This study is for people who have recently had surgery to remove oesophageal (food pipe) or gastroesophageal junction (where the food pipe meets the stomach) cancer, whether it's adenocarcinoma or squamous cell carcinoma. It's testing a drug called Nivolumab (also known as OPDIVO) against a dummy drug (placebo) to see if it can stop the cancer from returning. Researchers want to find out if patients who receive Nivolumab live longer without their cancer coming back compared to those who receive the placebo. They will also look at how long people live overall. This is a large study (Phase III) to confirm if Nivolumab is effective and safe as an 'adjuvant' treatment, meaning it's given after the main treatment (surgery) to reduce the risk of the cancer returning.
At a glance
What is this study about?
This research study is looking into a new treatment for a type of cancer that affects the food pipe (oesophagus) or the area where the food pipe joins the stomach (gastroesophageal junction). This particular study is for people who have already had surgery to remove their cancer. The aim is to see if a drug called Nivolumab can help prevent the cancer from coming back after surgery.
After cancer surgery, there's always a risk that some tiny cancer cells might have been left behind, even if they can't be seen. These cells could cause the cancer to return later. This study is trying to answer whether taking Nivolumab after surgery can reduce this risk and improve how long people stay cancer-free.
Researchers will compare Nivolumab with a 'placebo' – which looks just like the real drug but contains no active medicine. This comparison helps them understand if any benefits seen are truly due to Nivolumab and not just other factors. They will be carefully tracking how long people live without their cancer returning, and also how long people live overall, to see if Nivolumab makes a difference.
Key takeaways
- Tests a new drug (Nivolumab) to prevent cancer recurrence after surgery.
- For oesophageal or gastroesophageal junction cancer that has been removed.
- Compares Nivolumab to a dummy drug (placebo).
- Aims to see if patients live longer without their cancer returning.
- Involves regular hospital visits for treatment and monitoring.
- Participation includes long-term follow-up to track your health.
Who may be eligible?
This study is looking for both men and women aged 18 or older. You would be considered if you have had surgery for a specific type of oesophageal or gastroesophageal junction cancer – either adenocarcinoma or squamous cell carcinoma.
It's important that your cancer has been successfully removed by surgery. The study is designed for patients who are recovering from their operation and now need further treatment to try and prevent the cancer from coming back.
There will be other detailed medical checks to make sure your overall health is suitable for taking part and that the treatment would be safe for you. These will be discussed with you by the research team.
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 old or older?
- Have you had surgery to remove oesophageal or gastroesophageal junction cancer?
- Is your cancer type adenocarcinoma or squamous cell carcinoma?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you generally feeling well enough to participate in a medical study?
What does participation involve?
If you join this study, you would first go through some screening tests to check if you're suitable. Once confirmed, you would be randomly assigned to receive either Nivolumab or the placebo. Neither you nor your doctor would know which one you are receiving – this is called 'double-blind'.
The treatment would be given as a drip into your arm (an infusion) at regular intervals. You would have planned clinic visits where the study team would monitor your health, check for any side effects, and carry out tests like blood samples or scans to see how you are doing and check for any signs of the cancer returning.
Your participation would involve regular visits for treatment and check-ups over a period of time, followed by long-term follow-up to track your health. The total duration of your involvement could be several years, even after you stop receiving the study drug, to monitor your long-term health and any return of the cancer.
Potential risks and benefits
Locations (10)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedRomania
- —UnverifiedIreland
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedDenmark
- —UnverifiedNetherlands
- —UnverifiedGermany
Common questions
What is 'resected' cancer?
Resected means the cancer has been removed by surgery.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real drug but contains no active medicine.
What does 'double-blind' mean?
Double-blind means neither you nor your doctor will know if you are receiving the active drug or the placebo.
What is 'disease-free survival'?
This is how long you live after treatment without the cancer coming back.
Can I still receive my usual care if I join?
Yes, joining the study will not affect your standard medical care, and you can withdraw at any time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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