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Study of Durvalumab with Chemotherapy and Radiotherapy for Patients with Unresectable Esophageal Cancer

Verified siteRegistered 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 treatments for unresectable esophageal cancer, which means the cancer cannot be removed through surgery. The study involves patients with two types of esophageal cancer: adenocarcinoma and squamous cell carcinoma. The main treatment being tested is a medication called durvalumab, also known by its code name MEDI4736. Durvalumab is used in combination with other treatments, including FOLFOX (a chemotherapy regimen that includes fluorouracil, folinic acid, and oxaliplatin) and a type of radiation therapy called IMRT (Intensity-Modulated Radiation Therapy).

The purpose of the study is to evaluate how effective durvalumab is when used alongside these treatments and then as a maintenance therapy, which means it is continued after the initial treatment to help keep the cancer from coming back. The study will compare the outcomes of patients receiving this combination of treatments to those receiving other standard treatments. Patients will receive the treatments over a period of time, and their progress will be monitored to see how well the cancer responds and how long they remain free from cancer progression.

Throughout the study, the safety of the treatments will be closely monitored, and any side effects will be recorded. The study will also assess the overall survival of patients, which refers to the length of time patients live after starting the treatment, regardless of whether the cancer progresses. Additionally, the quality of life of patients will be evaluated using questionnaires designed to understand how the treatments affect their daily lives and well-being. The study aims to provide valuable information on the potential benefits of combining radiochemotherapy and immunotherapy for treating unresectable esophageal cancer.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with a combination of medications and radiation therapy. The medications include durvalumab, fluorouracil, folinic acid, and oxaliplatin. These are administered as solutions for infusion.

    Durvalumab is given as a concentrate for solution for infusion. The specific dosage and frequency will be determined by the medical team based on individual patient needs.

    The radiation therapy involves Intensity-Modulated Radiation Therapy (IMRT) with a total dose of 50 Gy. This is a type of radiation treatment that uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor.

  2. Step 2

    Maintenance therapy phase

    After the initial treatment phase, durvalumab is continued as a maintenance therapy. This phase aims to maintain the effects of the initial treatment and prevent the progression of the disease.

    The duration and frequency of durvalumab administration during this phase will be determined by the medical team.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess the treatment's effectiveness and any side effects. This includes clinical examinations, vital signs checks, electrocardiograms (ECG), and laboratory tests.

    Progression-Free Survival (PFS) and Overall Survival (OS) will be evaluated. PFS is the time from the start of the trial until the disease progresses or the patient passes away. OS is the time from the start of the trial until death from any cause.

    Quality of life will be assessed using questionnaires designed for patients with cancer, focusing on physical, emotional, and social well-being.

Who can join the trial?

17 criteria

  • The patient must have a type of esophageal cancer called squamous cell carcinoma or adenocarcinoma, confirmed by a test called a biopsy.
  • The patient must have normal results from blood tests done within 7 days before joining the study.
  • The patient must have normal blood clotting, shown by a test called prothrombin time (PT), within 7 days before joining the study.
  • The patient must have normal levels of calcium, potassium, and magnesium in their blood, checked within 7 days before joining the study.
  • Women must be past menopause or agree to use effective birth control during the study and for at least 6 months after. Non-menopausal women must have a negative pregnancy test within 72 hours before joining. Men must agree to use effective birth control during the study and for at least 6 months after, especially after the last dose of a drug called oxaliplatin.
  • The patient must agree to participate by signing a consent form before any study-related procedures.
  • The patient must be part of a social security system.
  • The patient must have a uracilemia level less than 16 ng/ml, which is a measure of a substance in the blood.
  • The patient must have a forced expiratory volume (FEV) greater than 1 liter or more than 50% of the expected value, which measures lung function.
  • The cancer must be unresectable, meaning it cannot be removed by surgery due to its location or the patient's health condition.
  • The patient must have at least one tumor that can be measured and is larger than 10 mm, as seen on a special type of X-ray called a spiral CT scan.
  • The patient must not have had any previous treatment for this cancer, including chemotherapy or radiotherapy, except for radiotherapy given for another cancer that is now in remission for the past 5 years.
  • The patient must be 18 years old or older.
  • The patient must have a WHO performance status of less than 2, which means they are fully active or can do light work.
  • The patient must weigh more than 35 kg (about 77 pounds).
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must have normal blood cell counts from tests done within 7 days before joining the study.

Who cannot join the trial?

5 criteria

  • Patients who have had any prior **chemotherapy** (treatment with drugs to kill cancer cells), **surgery** (operation), or **radiotherapy** (treatment with high-energy rays) for their esophageal cancer cannot participate.
  • Patients with any other type of cancer besides **adenocarcinoma** or **squamous cell carcinoma** of the esophagus are not eligible. Adenocarcinoma and squamous cell carcinoma are specific types of cancer that start in different types of cells in the esophagus.
  • Patients with esophageal cancer that can be surgically removed are not eligible. **Unresectable** means the cancer cannot be removed with surgery.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which may include those who cannot give consent or have special needs, are not eligible.
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Investigated drugs

  • Durvalumab

    is an immunotherapy medication used in this trial. It helps the body's immune system to detect and fight cancer cells more effectively. In this study, it is initially combined with other treatments and later used as a maintenance therapy to help manage localized unresectable esophageal cancer.

  • FOLFOX

    is a combination of chemotherapy drugs used to treat cancer. It includes a mix of medications that work together to stop the growth of cancer cells. In this trial, FOLFOX is used alongside other treatments to help manage esophageal cancer.

  • IMRT 50 Gy

    stands for Intensity-Modulated Radiation Therapy, which is a type of radiation treatment. It uses advanced technology to target cancer cells more precisely, minimizing damage to surrounding healthy tissue. In this trial, it is used in combination with other therapies to treat esophageal cancer.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating localized unresectable esophageal cancer, specifically adenocarcinoma or squamous cell carcinoma, without prior chemotherapy, surgery, or radiotherapy. The main therapeutic indication for durvalumab in this context is to improve progression-free survival in patients. At the molecular level, durvalumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.

Investigated diseases

Localized Unresectable Adenocarcinoma or Squamous Cell Carcinoma of the Oesophagus – This disease involves cancer that originates in the cells lining the esophagus, which is the tube connecting the throat to the stomach. In this condition, the cancer is confined to the esophagus but cannot be surgically removed due to its location or extent. Adenocarcinoma typically begins in glandular cells, while squamous cell carcinoma starts in the flat cells lining the esophagus. The disease progresses as the cancer cells grow and potentially invade nearby tissues, but it has not spread to distant parts of the body. Patients with this condition have not received prior chemotherapy, surgery, or radiotherapy. The progression of the disease is monitored to assess changes in the size or spread of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512165-13-00Protocol codeUC-0110/1719Estimated enrolment120 patientsSponsorUnicancer

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