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Study on Atezolizumab with Drug Combination for Patients with Gastric Cancer and Esophagogastric Junction Adenocarcinoma

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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 and another type known as adenocarcinoma of the esophagogastric junction. These cancers affect the stomach and the area where the esophagus meets the stomach. The study is investigating the effectiveness and safety of a treatment combination that includes a medication called atezolizumab, which is also known by its code name RO5541267, in combination with a chemotherapy regimen called FLOT. FLOT is a combination of four drugs: fluorouracil, leucovorin, oxaliplatin, and docetaxel. The study will compare this combination to the FLOT regimen alone.

The purpose of the study is to see if adding atezolizumab to the FLOT regimen can improve outcomes for patients. Participants in the study will receive treatment over a period of up to 12 months. The study will monitor how well the cancer responds to the treatment and how long patients remain free from cancer progression or relapse after surgery. Some participants will receive the combination of atezolizumab and FLOT, while others will receive only the FLOT regimen. A placebo may be used in some cases to help compare the effects of the treatments.

Throughout the study, participants will undergo regular assessments to monitor their health and the status of their cancer. These assessments may include imaging tests like MRI or CT scans to check for changes in the cancer. The study aims to provide valuable information on whether the addition of atezolizumab can offer better outcomes for patients with these types of cancer. The trial is expected to continue until 2028, with the goal of improving treatment options for patients with gastric cancer and adenocarcinoma of the esophagogastric junction.

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 treatment phase

    The initial treatment phase involves the administration of a combination of medications. These medications are given through an intravenous (IV) route, which means they are delivered directly into the bloodstream through a vein.

    The medications used in this phase include calcium folinate pentahydrate, oxaliplatin, atezolizumab, fluorouracil, and docetaxel. Each of these medications is provided as a solution for injection or infusion.

  2. Step 2

    Medication administration schedule

    The specific schedule for medication administration is determined by the study protocol. Each medication has a defined dosage and frequency, which is carefully followed to ensure the effectiveness and safety of the treatment.

    The duration of this phase is based on the study's design and may vary depending on individual response and tolerance to the treatment.

  3. Step 3

    Surgical intervention

    Following the initial treatment phase, a surgical procedure may be performed. This surgery is intended to remove the tumor and any affected tissues, as deemed necessary by the medical team.

    The timing and specifics of the surgery are planned according to the patient's condition and the study's requirements.

  4. Step 4

    Post-surgery treatment phase

    After surgery, additional treatment may be administered to support recovery and reduce the risk of cancer recurrence. This phase may involve further administration of the medications used in the initial treatment phase.

    The post-surgery treatment is tailored to the patient's needs and the study's objectives, ensuring comprehensive care throughout the trial.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and response to the treatment. These appointments include various assessments and tests to evaluate the effectiveness of the treatment and detect any potential side effects.

    The follow-up period is an essential part of the trial, providing valuable information on the long-term outcomes of the treatment.

Who can join the trial?

10 criteria

  • Must have given written permission to participate in the study.
  • Must have good blood, liver, and kidney function. This means having enough white blood cells, platelets, and red blood cells, and normal levels of certain substances in the blood like bilirubin, liver enzymes, and creatinine.
  • Must be willing and able to follow the study plan, including having surgery if needed.
  • Must be 18 years of age or older.
  • Must have a confirmed diagnosis of a specific type of cancer in the stomach or where the stomach meets the esophagus. The cancer must be at a stage where it can be removed by surgery and not spread to other parts of the body.
  • Must not have had any previous cancer treatments like chemotherapy or targeted therapy.
  • Must not have had any part of the esophagus or stomach removed due to cancer.
  • Must have a performance status of 0 or 1 on the ECOG scale, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • For Phase II: Must have a tumor sample available for testing certain markers like PD-L1 and MSI. For Phase III: Must have results for specific markers like MSI-high, PD-L1 CPS≥1, TMB ≥10/MB, or EBV+ before starting the study.
  • Women who can have children must agree to use highly effective birth control methods or not have heterosexual intercourse during the study and for at least 5 months after the last treatment. Men must agree to use birth control methods or not have heterosexual intercourse during the study and for at least 3 months after the last treatment. Men must also agree not to donate sperm during this time.

Who cannot join the trial?

9 criteria

  • Patients with other types of cancer that are not the specific type being studied cannot participate.
  • Patients who have had previous treatment for this type of cancer, such as surgery, chemotherapy, or radiation, are not eligible.
  • Patients with serious heart problems, like heart failure or a recent heart attack, cannot join the study.
  • Patients with severe liver or kidney disease are excluded from participating.
  • Patients with uncontrolled infections, meaning infections that are not being effectively treated, cannot take part.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with a history of severe allergic reactions to similar medications are excluded.
  • Patients who are currently participating in another clinical trial cannot join this study.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are not eligible.
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Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells. In this study, it is being tested in combination with another treatment to see if it can improve outcomes for patients with gastric cancer and adenocarcinoma of the oesophago-gastric junction.

  • FLOT

    is a combination of four chemotherapy drugs used to treat certain types of cancer, including gastric cancer. It includes a mix of medications that work together to kill cancer cells or stop them from growing. In this trial, FLOT is used both alone and in combination with atezolizumab to evaluate its effectiveness in treating the cancer.

What is already known about the treatment

Atezolizumab – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating gastric cancer and adenocarcinoma of the esophagogastric junction. Atezolizumab is primarily used to help the immune system fight cancer by blocking a protein that prevents immune cells from attacking cancer cells. It belongs to a class of drugs known as immune checkpoint inhibitors.

Investigated diseases

Adenocarcinoma of the Esophagogastric Junction – This is a type of cancer that occurs where the esophagus meets the stomach. It begins in the glandular cells that line the esophagus and stomach, which are responsible for producing mucus and other fluids. The disease is considered locally advanced when it has spread to nearby tissues or lymph nodes but not to distant parts of the body. As it progresses, the tumor may grow larger and invade surrounding structures, potentially causing symptoms like difficulty swallowing or weight loss. The condition is termed resectable when it can be surgically removed, although surgery may be complex due to the tumor's location. The progression of the disease can vary, and it may require a combination of treatments to manage effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-514945-12-00Protocol codeDANTE/FLOT8Estimated enrolment674 patientsSponsorFrankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

sourced from the EU Clinical Trials Register and site verification

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