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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Frisius Heerenveen The Netherlands

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Snbnfhbmb Rfgsbhj Uplnekksxd Mkjihxe Ckqzhr Nijmegen The Netherlands
Eqzrfmf Usmnapqizmoc Mvqkqid Chdcnqk Rvdkrdzhg (aaoktjc Mgb Rotterdam The Netherlands
Sah Ehixufidr Hdaoryfo Tmruhyl Tilburg The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.09.2022

Trial locations

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.

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 ID:
2024-513635-24-00
NCT ID:
NCT05491616
Trial Phase:
Therapeutic use (Phase IV)

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