Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Nivolumab for Patients with Esophageal Cancer Undergoing Active Surveillance After Chemoradiation

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called nivolumab on patients with esophageal cancer. Esophageal cancer is a disease where cancer cells form in the tissues of the esophagus, the tube that carries food from the mouth to the stomach. The study is specifically looking at patients who have already received a treatment called neoadjuvant chemoradiation, which is a combination of chemotherapy and radiation therapy given before surgery to shrink the tumor.

The purpose of this study is to evaluate how effective nivolumab is when used during a period of active surveillance. Active surveillance is a way of monitoring a patient's condition without giving any treatment unless there are changes in test results that show the disease is getting worse. In this study, patients who have shown a complete response to the initial treatment will receive nivolumab to see if it helps keep the cancer from coming back.

Participants in the study will receive nivolumab through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients over a period of time to see how long they remain free of cancer and to observe any side effects that may occur. The goal is to understand if nivolumab can help improve outcomes for patients with esophageal cancer who are in active surveillance after their initial treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing neoadjuvant chemoradiotherapy for esophageal cancer and achieving a clinically complete response.

    Eligibility requires being part of an active surveillance protocol and providing informed consent.

  2. Step 2

    Treatment with nivolumab

    Receive treatment with nivolumab, a medication administered through an intravenous infusion.

    The medication is provided as a solution for infusion, with a concentration of 10 mg/mL.

  3. Step 3

    Active surveillance

    Undergo regular monitoring to assess the effectiveness of the treatment and detect any recurrence of the disease.

    The primary goal is to evaluate disease-free survival, which is the time until any recurrence or death.

  4. Step 4

    Monitoring for adverse events

    Be aware of potential adverse events, including serious or grade 3-4 events, as defined by the Common Terminology Criteria for Adverse Events.

    Report any side effects experienced during the treatment period.

  5. Step 5

    Completion of the study

    The study is expected to conclude by December 31, 2026.

    Final assessments will be conducted to determine the overall outcomes of the treatment.

Who can join the trial?

8 criteria

  • Patients must have **operable** esophageal cancer, which means the cancer can be treated with surgery.
  • The cancer should be **locoregionally advanced**, meaning it has spread to nearby areas but not to distant parts of the body.
  • The type of cancer should be either **squamous cell carcinoma** or **adenocarcinoma** of the esophagus or the area where the esophagus meets the stomach.
  • Patients must have completed **neoadjuvant chemoradiotherapy (nCRT)**, which is a treatment given before surgery that includes both chemotherapy and radiation therapy.
  • Patients should have a **clinically complete response** 10-14 weeks after nCRT, meaning there are no signs of cancer detectable with current medical tests.
  • Patients must be part of an **active surveillance protocol**, which means they are being closely monitored instead of having immediate surgery.
  • Patients must be at least **18 years old**.
  • Patients need to provide **written, voluntary, informed consent**, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

  • Patients who have not achieved a complete clinical response (cCR) after receiving neoadjuvant chemoradiation for esophageal cancer. This means the cancer has not fully responded to the treatment given before surgery.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who belong to a vulnerable population. This refers to groups of people who might be at a higher risk of harm or exploitation.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Nivolumab is a medication used in this trial to help the immune system fight cancer cells. It is being tested for its effectiveness in patients with esophageal cancer who have already received chemoradiation therapy. The goal is to see if nivolumab can help control the cancer during a period of active monitoring, known as active surveillance.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating esophageal cancer, particularly during active surveillance after patients have undergone neoadjuvant chemoradiation. The main therapeutic indication for nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on the surface of immune cells, which enhances the body's immune response against cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy used in cancer treatment.

Investigated diseases

Esophageal Cancer – Esophageal cancer is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As the cancer progresses, it may cause symptoms such as difficulty swallowing, weight loss, and chest pain. The disease can spread to nearby lymph nodes and other parts of the body, such as the liver and lungs. The progression of esophageal cancer can vary, with some cases growing slowly and others advancing more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513635-24-00Estimated enrolment74 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.