Ongoing Clinical Trials for Oesophageal Squamous Cell Carcinoma Stage III
Currently, there is one ongoing clinical trial for patients with Stage III oesophageal squamous cell carcinoma who have undergone surgery following chemotherapy and radiation therapy. This trial is testing an immunotherapy treatment called nivolumab across multiple European countries to see if it can help prevent cancer from returning after surgery.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- France
- Germany
- Ireland
- Netherlands
- Poland
- Romania
- Spain
Study of Nivolumab or Placebo for Patients with Removed Esophageal or Gastroesophageal Junction Cancer
This clinical trial is investigating the effectiveness of nivolumab in patients who have undergone surgery to remove cancer located in the oesophagus or at the junction where the oesophagus meets the stomach. The study is designed for patients who completed chemotherapy and radiation therapy before their surgery and were diagnosed with Stage II or Stage III cancer.
Who can participate:
- Patients who have had adenocarcinoma or squamous cell carcinoma of the oesophagus or gastroesophageal junction
- Those diagnosed with Stage II or Stage III cancer
- Patients who completed pre-operative chemoradiotherapy, which is a combination of chemotherapy and radiation given before surgery
- Those who have undergone surgery to remove the cancer with clear margins, meaning all visible cancer was removed
- Patients with residual pathologic disease, meaning some cancer cells were still present in the tissue examined after surgery
- Both male and female patients are eligible
Who cannot participate: The trial does not specify detailed exclusion criteria in the available information, but typically patients who do not meet the inclusion requirements or have certain health conditions that might interfere with the treatment would not be eligible.
What the trial aims to do: The main goal of this study is to determine how long patients can remain cancer-free after treatment with nivolumab compared to a placebo. This is measured as disease-free survival, which tracks the time from the start of treatment until the cancer returns or the patient passes away. The study also looks at overall survival, which measures how long patients live after starting the trial, regardless of whether the cancer comes back.
How the treatment works: Nivolumab, also known by its code name BMS-936558, is an immunotherapy medication that helps the immune system recognise and attack cancer cells. It works by blocking a protein called PD-1 on immune cells, which allows these cells to better fight cancer. The medication is given as an infusion directly into the bloodstream at a dose of 10 mg/mL. Participants in the study will receive either nivolumab or a placebo, and neither the patients nor the doctors will know which treatment is being given. This double-blind approach helps ensure that the results are not influenced by expectations about the treatment.
The study is being conducted across ten European countries and is expected to be completed by October 2025. Throughout the trial, patients will be closely monitored to track their progress and assess whether the cancer returns.
Summary
There is currently one active clinical trial available for patients with Stage III oesophageal squamous cell carcinoma who have completed surgery after receiving chemotherapy and radiation therapy. This trial is testing nivolumab, an immunotherapy treatment that works by helping the immune system fight cancer cells more effectively.
The trial is widely available across Europe, being conducted in ten countries: Belgium, Czechia, Denmark, France, Germany, Ireland, Netherlands, Poland, Romania, and Spain. This broad geographic coverage provides more opportunities for eligible patients to participate.
The focus of this research is on preventing cancer from returning after surgery, which is a critical concern for patients who have undergone treatment for this type of cancer. By comparing nivolumab to a placebo, researchers hope to determine whether this immunotherapy approach can improve outcomes for patients in this situation.
