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Study of Durvalumab with Chemoradiation Therapy for Patients with Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma

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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 called Esophageal Squamous Cell Carcinoma, which affects the esophagus, the tube that carries food from the mouth to the stomach. The study is specifically for patients with locally advanced cases of this cancer that cannot be removed by surgery. The main treatment being tested is a medication called Durvalumab, also known by its code name MEDI4736. Durvalumab is given alongside a standard treatment called chemoradiation therapy, which combines chemotherapy and radiation therapy to treat cancer. The study will compare the effects of Durvalumab with a placebo, which looks like the real treatment but does not contain any active medication.

The purpose of the study is to see how well Durvalumab works when used with chemoradiation therapy in treating this type of cancer. Participants in the study will receive either Durvalumab or a placebo, along with chemoradiation therapy. The study will monitor the participants over a period to observe the effects of the treatment on their cancer. The study will also collect information on how the treatment affects the participants' quality of life and any side effects they may experience.

Other medications involved in the study include Fluorouracil, Cisplatin, and Capecitabine, which are types of chemotherapy drugs, as well as Infliximab and Mycophenolate Mofetil, which are used to manage immune responses. These medications are administered in different forms, such as injections, infusions, or tablets, depending on the specific treatment plan. The study aims to provide valuable information on the effectiveness and safety of using Durvalumab in combination with these treatments for patients with this type of esophageal cancer.

The research process

The trial runs in 4 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 a review of medical history and a physical examination.

    A sample of tumor tissue is required for analysis to determine the presence of a specific protein called PD-L1.

  2. Step 2

    Treatment phase

    The treatment phase involves receiving a combination of medications and radiation therapy.

    The medications include fluorouracil and cisplatin, administered through an intravenous injection and infusion, respectively.

    Additionally, capecitabine is taken orally in the form of film-coated tablets.

    The main medication being studied is durvalumab, given as an intravenous infusion. Some participants may receive a placebo instead of durvalumab.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects.

    This includes imaging tests and blood tests to evaluate the progression of the disease and the concentration of durvalumab in the blood.

    Participants are also asked to complete questionnaires about their symptoms and quality of life.

  4. Step 4

    End of treatment

    At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

    Participants may continue to be monitored for a period after the treatment to gather additional data on long-term effects and outcomes.

Who can join the trial?

9 criteria

  • Must be **18 years or older** at the time of signing the informed consent form.
  • Must have **esophageal squamous cell carcinoma**, which is a type of cancer in the esophagus, confirmed by tests.
  • The cancer must be **locally advanced**, meaning it has spread nearby but not to distant parts of the body, and be at **Stage II to IVA**.
  • The cancer must be **unresectable**, meaning it cannot be removed by surgery, or the patient must refuse surgery. The patient should be suitable for **definitive chemoradiation therapy**, which is a combination of chemotherapy and radiation therapy.
  • Must have at least one **evaluable lesion**, which is a tumor that can be measured, according to specific guidelines called **RECIST 1.1**.
  • Must provide available **tumor tissue** for testing **PD-L1 expression**, which is a protein that may be present on cancer cells.
  • Must have an **ECOG performance status** of 0 or 1, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
  • Must have **adequate organ and marrow function**, meaning the organs and bone marrow are working well enough.
  • Must have a **life expectancy of more than 3 months**.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had previous treatment for their esophageal cancer that is not allowed in the study.
  • Patients with other serious health conditions that could interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an allergy to the study medication or any of its ingredients.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent infection that requires treatment with antibiotics.
  • Patients with a history of certain heart conditions that could be worsened by the study treatment.
  • Patients who have received a live vaccine within a certain period before starting the study treatment.
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Investigated drugs

Durvalumab is a medication used in this clinical trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this study, it is given to patients with esophageal squamous cell carcinoma to see if it can improve their condition when used alongside standard cancer treatments like chemotherapy and radiation therapy.

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 locally advanced, unresectable esophageal squamous cell carcinoma. The main therapeutic indication for durvalumab in this context is to improve progression-free survival in patients with specific tumor characteristics. At the molecular level, durvalumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. This medication is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer cells.

Investigated diseases

Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma – This is a type of cancer that occurs in the esophagus, specifically affecting the squamous cells lining the esophagus. It is termed "locally advanced" because the cancer has spread beyond the innermost layer of the esophagus but has not metastasized to distant parts of the body. "Unresectable" indicates that the tumor cannot be surgically removed due to its size, location, or involvement with surrounding structures. The disease progresses as the cancer cells grow and invade nearby tissues, potentially causing symptoms such as difficulty swallowing, chest pain, and weight loss. As the condition advances, it may lead to further complications affecting the esophagus and surrounding areas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506413-22-00Protocol codeD910SC00001/KUNLUNEstimated enrolment523 patientsSponsorAstraZeneca AB

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