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1 clinical trial in this condition
BelgiumIn short
There is currently 1 ongoing clinical trial for patients with Stage II oesophageal adenocarcinoma who have undergone surgery following chemotherapy and radiation therapy. The trial is investigating whether nivolumab, an immunotherapy drug, can help prevent cancer from returning after surgical removal of the tumour. The study is being conducted across multiple European countries including France, Ireland, Romania, Poland, Denmark, Czechia, Belgium, Germany, Spain, and the Netherlands.
This trial is designed for patients who have undergone surgery to remove cancer located in the oesophagus or at the junction where the oesophagus meets the stomach. The study focuses on patients with Stage II or Stage III disease who received chemotherapy and radiation therapy before their operation.
Who can join this trial?
To be eligible for this study, patients must have been diagnosed with either adenocarcinoma or squamous cell carcinoma in the oesophagus or gastroesophageal junction. They must have completed pre-operative chemoradiotherapy, which is a combination of chemotherapy and radiation given before surgery. Following surgery, some cancer cells should have still been present, but the operation must have successfully removed all visible cancer with clear margins. Both men and women can participate, including those from vulnerable populations who may need special care or protection.
Who cannot join this trial?
The trial information provided does not specify exclusion criteria in detail, but typically patients who have not completed the required pre-surgery treatments or whose cancer has spread extensively beyond the surgical site would not be suitable candidates.
What is the goal of this trial?
The main purpose of this study is to determine how long patients can remain cancer-free after receiving nivolumab compared to those receiving a placebo. The primary measure is disease-free survival, which tracks the time from when treatment begins until the cancer returns or the patient passes away. The study also looks at overall survival, measuring how long patients live after starting the trial regardless of whether their cancer comes back. This is a double-blind study, meaning neither the patients nor the researchers know who is receiving the actual treatment versus the placebo, which helps ensure unbiased results. The study is expected to conclude in October 2025.
What treatment is being tested?
The investigational drug in this trial is nivolumab, also known by its code name BMS-936558. Nivolumab is an immunotherapy medication that works by helping the body's immune system recognize and attack cancer cells. Specifically, it blocks a protein called PD-1 on immune cells called T-cells, which enhances the immune system's ability to fight cancer. The medication is given as an intravenous infusion directly into the bloodstream at a dosage of 10 mg/mL, administered in a clinical setting under medical supervision.
Currently, there is one clinical trial available for patients with Stage II oesophageal adenocarcinoma who have completed surgery following pre-operative chemoradiotherapy. This trial is investigating nivolumab, an immune checkpoint inhibitor, as a potential therapy to prevent cancer recurrence after surgical removal. The study is being conducted across ten European countries, offering access to patients in Belgium, Czechia, Denmark, France, Germany, Ireland, the Netherlands, Poland, Romania, and Spain. The widespread geographic distribution of this trial provides broader access to this investigational treatment for eligible patients across Europe. The focus on immunotherapy represents an important area of research in preventing cancer recurrence following surgery.
This guide is here to help you understand the condition. It does not replace a conversation with your doctor, who knows your situation best.
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