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Study on Durvalumab and FLOT Chemotherapy for Patients with Resectable Gastric and Gastroesophageal Cancer

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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 patients with a type of cancer called gastric cancer or gastroesophageal junction cancer. These are cancers that occur in the stomach or where the stomach meets the esophagus. The study will explore the effects of a medication called Durvalumab, which is given as an infusion, meaning it is delivered directly into the bloodstream through a vein. Durvalumab is being tested in combination with a chemotherapy regimen known as FLOT, which includes the drugs Fluorouracil, Leucovorin (also known as Folinic Acid), Oxaliplatin, and Docetaxel. These drugs are used to kill cancer cells or stop them from growing. The study will also involve a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of this study is to see if the combination of Durvalumab and FLOT chemotherapy, followed by additional Durvalumab treatment, can improve outcomes for patients with resectable gastric or gastroesophageal junction cancer. "Resectable" means that the cancer can be surgically removed. The study will be conducted in phases, starting with treatment before surgery (neoadjuvant) and continuing after surgery (adjuvant). Participants will be randomly assigned to receive either the active treatment or a placebo, and neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This is known as a double-blind study.

The study will last for a period of up to 18 months, during which participants will receive the treatments and be monitored for their health and response to the treatment. The main goal is to assess event-free survival, which means the length of time participants live without the cancer getting worse or coming back. Secondary goals include overall survival and the rate of complete response to the treatment. This study aims to provide valuable information on the effectiveness of Durvalumab in combination with FLOT chemotherapy for treating gastric and gastroesophageal junction cancers.

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

    Upon joining the study, the patient is confirmed to have a type of cancer called gastric or gastroesophageal junction adenocarcinoma that can be surgically removed.

    The patient must not have received any previous treatment for this cancer and should have a good performance status as per the World Health Organization (WHO) or Eastern Cooperative Oncology Group (ECOG) scale.

  2. Step 2

    Neoadjuvant treatment phase

    The patient receives a combination of medications before surgery, known as neoadjuvant treatment. This includes durvalumab administered intravenously, and a chemotherapy regimen called FLOT, which consists of fluorouracil, folinic acid, oxaliplatin, and docetaxel, all given intravenously.

    The purpose of this phase is to shrink the tumor before surgical removal.

  3. Step 3

    Surgery

    The patient undergoes surgery to remove the cancerous tissue. This is a critical step in the treatment process.

  4. Step 4

    Adjuvant treatment phase

    After surgery, the patient receives additional treatment to eliminate any remaining cancer cells. This is known as adjuvant treatment.

    The patient continues to receive durvalumab intravenously to help prevent cancer recurrence.

  5. Step 5

    Follow-up and monitoring

    The patient is regularly monitored to assess the effectiveness of the treatment and to check for any signs of cancer returning.

    This phase includes regular medical check-ups and imaging tests as needed.

Who can join the trial?

9 criteria

  • Patients must have a **confirmed diagnosis** of gastric or gastroesophageal junction adenocarcinoma. This means the cancer is in the stomach or where the stomach meets the esophagus, and it has been confirmed by examining tissue under a microscope.
  • The disease must be **resectable**, meaning it can be removed by surgery, and it should be at **Stage II or higher** according to the AJCC 8th edition, which is a system used to describe the extent of cancer.
  • Patients must have undergone **radical surgery**, which is a type of surgery aimed at removing all cancerous tissue.
  • No previous **anti-cancer therapy** should have been received for the current cancer. This means the patient should not have had treatments like chemotherapy or radiation for this cancer before.
  • Patients should have a **World Health Organization (WHO)/ECOG Performance Status** of 0 or 1 at enrollment. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Patients must have **adequate organ and marrow function**, meaning their organs and bone marrow are working well enough to handle the treatment.
  • A **tumor sample** must be available before entering the study. This is a piece of the cancer that has been removed and can be used for testing.
  • Patients must have a **life expectancy** of at least 24 weeks, meaning they are expected to live for at least 24 weeks.
  • Both **male and female** patients can participate.

Who cannot join the trial?

7 criteria

  • Patients with a type of stomach cancer called **adenocarcinoma** that is not at a stage where it can be surgically removed.
  • Patients with a type of cancer that is not located in the stomach or the area where the stomach meets the esophagus.
  • Patients who have a type of cancer that is not classified as Stage II or higher according to the **AJCC 8th edition**, which is a system used to describe the extent of cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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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 both before and after surgery to see if it can improve the chances of the cancer not coming back.

  • FLOT Chemotherapy

    is a combination of four different chemotherapy drugs used together to treat gastric and gastroesophageal junction cancer. This combination is used to shrink the tumor before surgery and to kill any remaining cancer cells after surgery. The goal is to improve the overall effectiveness of the treatment and increase the chances of a successful outcome.

What is already known about the treatment

Durvalumab – Durvalumab is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its effectiveness in treating certain types of cancer, including gastric and gastroesophageal junction cancer. The main therapeutic indication for Durvalumab is its use as an immunotherapy to help the body's immune system recognize and attack cancer cells. At the molecular level, Durvalumab works by blocking the PD-L1 protein, which can prevent the immune system from attacking cancer cells. It is classified as a monoclonal antibody within the pharmacological category of immune checkpoint inhibitors.

Investigated diseases

  • Gastric Adenocarcinoma

    This is a type of cancer that begins in the glandular cells of the stomach lining. It typically progresses by invading the stomach wall and can spread to nearby lymph nodes and other organs. The disease is often categorized by stages, with Stage II or higher indicating more advanced disease. Symptoms may include abdominal pain, weight loss, and nausea. The progression can vary, with some cases remaining localized while others spread more extensively. Early detection is crucial for managing the disease effectively.

  • Gastroesophageal Junction Adenocarcinoma

    This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It develops from the glandular cells in this area and can progress by invading surrounding tissues and spreading to other parts of the body. The disease is staged similarly to gastric adenocarcinoma, with higher stages indicating more extensive disease. Common symptoms include difficulty swallowing, chest pain, and unintended weight loss. The progression can lead to complications if not addressed in a timely manner. Understanding the stage of the disease is important for determining the appropriate management approach.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507338-26-00Protocol codeD910GC00001Estimated enrolment905 patientsSponsorAstraZeneca AB

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