Ongoing Clinical Trials for Oesophageal Squamous Cell Carcinoma Stage II
This article provides information about ongoing clinical trials for patients with Stage II oesophageal squamous cell carcinoma. Currently, there is 1 clinical trial investigating treatment options for patients who have undergone surgery to remove their cancer. This trial is being conducted across multiple European countries and focuses on preventing cancer recurrence 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 designed for patients who have undergone surgery to remove cancer of the oesophagus or gastroesophageal junction, which is the area where the oesophagus meets the stomach. The study examines whether a medication called nivolumab can help prevent the cancer from returning after surgery.
Who can participate: The trial is open to patients who have been diagnosed with Stage II or III cancer in the oesophagus or gastroesophageal junction. Eligible participants must have either squamous cell carcinoma or adenocarcinoma, the two main types of cancer that can develop in these areas. To join the study, patients must have completed a treatment approach called pre-operative chemoradiotherapy, which combines chemotherapy and radiation therapy given before surgery. Following this treatment, patients must have had surgery to remove the cancer, with all visible cancer removed and clear margins, though some cancer cells may still have been present in the tissue examined after surgery. Both men and women are welcome to participate.
Main focus and goals: The primary purpose of this study is to determine whether nivolumab can help patients live longer without their cancer returning. This is measured through something called disease-free survival, which tracks the time from when treatment begins until the cancer comes back or the patient passes away. The study also looks at overall survival, which is how long patients live after starting the treatment, regardless of whether the cancer returns. The researchers want to understand if nivolumab provides a benefit compared to a placebo, which is an inactive treatment that looks the same but contains no medication.
How the study works: Participants will be randomly assigned to receive either nivolumab or the placebo. Neither the patients nor the researchers will know which treatment each person is receiving during the study, which helps ensure the results are not influenced by expectations. Nivolumab is given as an infusion directly into the bloodstream through a vein at a dosage of 10 mg/mL. The treatment schedule and duration follow the study protocol, and patients will be monitored regularly to check for any signs of cancer recurrence.
The investigational drug: Nivolumab, also known by its code name BMS-936558, is a type of immunotherapy medication. It works by blocking a protein called PD-1 on immune cells called T-cells. By blocking this protein, nivolumab helps the immune system recognize and attack cancer cells more effectively. This medication is classified as a monoclonal antibody and belongs to a group of treatments known as immune checkpoint inhibitors. Nivolumab is already used to treat various types of cancer and is being studied in this trial specifically to see if it can prevent cancer recurrence after surgery.
The study is expected to conclude by October 2025, and participants will be informed of relevant findings related to their health. This research aims to provide valuable information about whether adding nivolumab to the standard care after surgery can improve outcomes for patients with oesophageal or gastroesophageal junction cancer.
Summary
Currently, there is one ongoing clinical trial available for patients with Stage II oesophageal squamous cell carcinoma who have undergone surgery. This trial is being conducted across ten European countries, including Belgium, Czechia, Denmark, France, Germany, Ireland, Netherlands, Poland, Romania, and Spain, providing broad access to patients across Europe.
The trial focuses on testing nivolumab, an immunotherapy drug that helps the immune system fight cancer cells. The study is particularly relevant for patients who have completed chemotherapy and radiation therapy before surgery and have had their cancer surgically removed. The main goal is to determine whether this treatment can help prevent cancer from returning after surgery.
This trial represents an important research effort to improve long-term outcomes for patients with this type of cancer, particularly in preventing recurrence after surgical treatment. The wide geographic distribution of trial sites across Europe makes this research accessible to patients in multiple countries.
