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Study on Tocilizumab for Patients with Esophageal Cancer to Improve Chemoradiotherapy Outcomes

Registered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of cancer known as esophageal adenocarcinoma, which is a form of esophageal cancer. The study is investigating the use of a medication called tocilizumab, which is also known by other names such as RO4877533 and BIIB800. Tocilizumab is administered through an intravenous route, meaning it is given directly into a vein. The purpose of this study is to see if targeting certain cells in the body, called stromal cells, with tocilizumab can improve the effectiveness of standard cancer treatments like chemotherapy and radiation therapy.

Participants in the study will receive either tocilizumab or a placebo, in addition to their regular cancer treatment. The study will monitor how well the cancer responds to the treatment by looking at changes in the tumor tissue. This will help researchers understand if tocilizumab can make the standard treatment more effective. The study will also look at other factors, such as the rate of successful tumor removal through surgery and the overall survival of participants.

Throughout the study, researchers will collect information on the safety of tocilizumab, including any side effects or complications that may arise. They will also measure certain proteins and genes in the blood and tumor tissue to understand how tocilizumab works in the body. The study aims to provide valuable insights into whether tocilizumab can be a beneficial addition to the treatment of esophageal adenocarcinoma.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of esophageal adenocarcinoma or high-grade dysplasia with suspicion of adenocarcinoma.

    A negative pregnancy test is required for women of child-bearing potential. Consent is documented, and accessibility for follow-up is confirmed.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of tocilizumab, an intravenous medication. The dosage and frequency are determined by the study protocol.

    Tocilizumab targets the stroma, a supportive tissue in tumors, to enhance the effectiveness of chemoradiotherapy.

  3. Step 3

    Chemoradiotherapy

    Following tocilizumab administration, chemoradiotherapy is provided. The response to this treatment is evaluated using the Mandard criteria, which assess the tumor's pathological response.

    The primary goal is to improve the effectiveness of chemoradiotherapy through stroma-targeting.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess treatment response and any side effects. This includes measuring levels of certain proteins and genes related to the IL-6-STAT3 pathway.

    Secondary outcomes such as survival rates, surgical outcomes, and treatment completion rates are also evaluated.

  5. Step 5

    Completion and follow-up

    The trial concludes with a final assessment of the treatment's effectiveness and any long-term effects. This includes evaluating the primary endpoint of pathological response and secondary endpoints like survival and complication rates.

    Follow-up care is provided as needed, and data is collected for analysis.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of **adenocarcinoma** of the esophagus or the area where the esophagus meets the stomach. **Adenocarcinoma** is a type of cancer that forms in mucus-secreting glands.
  • The cancer must be considered **surgically resectable**, meaning it can be removed through surgery.
  • The patient must have a **creatinine clearance** of at least 60 ml/min. **Creatinine clearance** is a test that measures how well the kidneys are working.
  • If the patient is a woman who can have children, she must have a negative pregnancy test before starting the study. If she is sexually active, she must agree to use effective birth control during the study and for a period after the study as advised by the study doctor.
  • The patient must provide written, voluntary informed consent to participate in the study. This means they agree to join the study after understanding all the details.
  • The patient must be able to attend follow-up appointments and receive treatment at the study center.
  • The study is open to both male and female patients.
  • The study includes adults and older adults.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than **esophageal adenocarcinoma** or **esophageal cancer**.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who do not meet other specific health conditions required for the study.
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Investigated drugs

Tocilizumab is a medication used in this trial to target the stroma, which is a supportive tissue surrounding cancer cells, in patients with esophageal adenocarcinoma. The goal is to see if using tocilizumab can improve the effectiveness of standard cancer treatments like chemoradiotherapy by reducing the activity of the stroma, potentially leading to better treatment outcomes.

What is already known about the treatment

Tocilizumab – Tocilizumab is administered through an intravenous infusion, typically in a clinical setting. It is currently being studied in clinical trials for its potential use in treating esophageal adenocarcinoma, a type of esophageal cancer. The main therapeutic indication being explored is its ability to enhance the effectiveness of chemoradiotherapy by targeting the stroma, which is the supportive tissue surrounding cancer cells. At the molecular level, tocilizumab works by inhibiting the interleukin-6 (IL-6) receptor, which plays a role in inflammation and may contribute to cancer progression. It is classified as an immunosuppressive drug, commonly used to treat autoimmune conditions like rheumatoid arthritis.

Investigated diseases

Esophageal adenocarcinoma – This is a type of cancer that forms in the glandular cells of the esophagus, which is the tube connecting the throat to the stomach. It typically begins in the lower part of the esophagus and is often associated with chronic acid reflux or Barrett's esophagus. As the disease progresses, it can cause difficulty swallowing, chest pain, and weight loss. The cancer cells can invade deeper layers of the esophagus and may spread to nearby lymph nodes and other organs. Over time, the tumor can grow and obstruct the esophagus, making it difficult for food and liquids to pass.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509458-77-00Estimated enrolment3 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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