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Study on the Effectiveness of Bemarituzumab and FLOT Chemotherapy for Patients with Resectable Gastric and Gastroesophageal Junction 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 a type of cancer called gastric and gastroesophageal junction adenocarcinoma. This cancer affects the stomach and the area where the stomach meets the esophagus. The study is investigating a treatment that combines a new drug called bemarituzumab with a chemotherapy regimen known as FLOT. FLOT is a combination of four drugs: fluorouracil, levoleucovorin, oxaliplatin, and docetaxel. These drugs are used to treat cancer by stopping the growth of cancer cells.

The purpose of the study is to evaluate how effective this combination treatment is when given before and after surgery to patients with this type of cancer. The study will involve patients who have a specific characteristic in their cancer cells, known as FGFR2b overexpression. This means that the cancer cells have higher levels of a protein called FGFR2b, which may make them more responsive to the treatment being tested.

Participants in the study will receive the treatment over a period of six months. The treatment will be administered through an intravenous infusion, which means it will be given directly into the bloodstream through a vein. The study will monitor the participants' health and the response of their cancer to the treatment. The goal is to see if the combination of bemarituzumab and FLOT can improve outcomes for patients with this type of cancer. The study will also track any side effects or complications that may arise during and after the treatment.

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 visit and preparation

    Upon joining the study, you will have an initial visit where medical staff will explain the trial process. You will receive detailed information about the medications and procedures involved.

    You will undergo a series of tests to confirm your eligibility, including providing a sample of your tumor tissue for analysis. This is to check for a specific protein called FGFR2b.

  2. Step 2

    Start of treatment

    The treatment involves a combination of medications administered through an intravenous infusion. This means the medication is given directly into your bloodstream through a vein.

    The medications include fluorouracil, docetaxel, oxaliplatin, bemarituzumab, and levoleucovorin. The exact dosage and frequency will be determined by the medical team based on your specific condition.

  3. Step 3

    Treatment schedule

    You will receive the treatment in cycles. Each cycle consists of a period of receiving the medication followed by a rest period to allow your body to recover.

    The medical team will monitor your health closely through regular visits and tests to ensure the treatment is working effectively and to manage any side effects.

  4. Step 4

    Surgery

    If the treatment is successful in reducing the size of the tumor, you may undergo surgery to remove the remaining cancerous tissue.

    The surgery will be followed by a recovery period, during which your health will continue to be monitored.

  5. Step 5

    Post-treatment follow-up

    After completing the treatment and surgery, you will have regular follow-up visits for up to five years. These visits are to monitor your recovery and check for any signs of cancer returning.

    During these visits, you will undergo various assessments, including nutritional status checks and quality of life evaluations.

Who can join the trial?

15 criteria

  • Participants must have signed and dated an informed consent form before any study-specific procedures. This means you agree to take part in the study and understand what it involves.
  • Participants must be willing and able to attend scheduled visits, follow the treatment schedule, and complete laboratory tests and other study requirements.
  • Participants must have a confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma. This is a type of cancer found in the stomach or where the stomach meets the esophagus.
  • Tumor tissue must be provided for analysis to check for FGFR2b overexpression. This is a specific protein found in some cancer cells.
  • The cancer must show positive FGFR2b overexpression status, meaning the protein is present in a certain amount of the tumor cells.
  • Participants must have an ECOG performance status score of 0 or 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
  • The cancer must be classified as cT2-T4a or N+ based on scans and tests, without spreading to distant parts of the body or nearby structures. If there is a suspicion of cancer spread in the abdomen, a procedure called laparoscopy is required to rule it out.
  • Participants must have adequate blood and organ function, as shown by specific laboratory tests. This includes:
    • Normal levels of liver enzymes (ALT and AST), which should be no more than three times the upper limit of normal.
    • Albumin levels of at least 30 g/L, which is a protein in the blood.
    • Adequate bone marrow function, with specific counts for white blood cells, platelets, and hemoglobin.
    • Normal kidney function, with a serum creatinine level no more than 1.5 times the upper limit of normal and a creatinine clearance of at least 50 mL/min.
    • Normal blood clotting function, unless on stable anticoagulation therapy.
    • Participants must be adults, 18 years of age or older.
    • Women who can become pregnant must agree to use contraception during the study and for a specified time after the last dose of study drugs.
    • Men who are sexually active with women who can become pregnant must agree to use contraception during the study and for a specified time after the last dose of study drugs.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides gastric and gastro-oesophageal junction adenocarcinomas cannot participate.
  • Patients who have had previous treatment with the same or similar drugs used in this study cannot participate.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are unable to follow the study procedures or comply with the study requirements cannot participate.
  • Patients with known allergies to the study drugs or their components cannot participate.
  • Patients who have participated in another clinical trial within a certain period before this study cannot participate.
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Investigated drugs

  • Bemarituzumab

    is a type of medication known as a monoclonal antibody. It is designed to target and attach to a specific protein called FGFR2b, which is found on the surface of some cancer cells. By binding to this protein, bemarituzumab can help slow down or stop the growth of cancer cells. In this clinical trial, bemarituzumab is being used to see if it can improve the effectiveness of chemotherapy in treating certain types of stomach and gastroesophageal junction cancers.

  • FLOT Chemotherapy

    is a combination of four different chemotherapy drugs used together to treat cancer. These drugs work in various ways to stop cancer cells from growing and dividing. FLOT stands for the names of the drugs in the combination: 5-Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel. This combination is used to treat stomach and gastroesophageal junction cancers, and in this trial, it is being tested in combination with bemarituzumab to see if it can be more effective in shrinking tumors before surgery.

What is already known about the treatment

Bemarituzumab – Bemarituzumab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials as a potential treatment for certain types of stomach cancer, specifically gastric and gastro-oesophageal junction adenocarcinomas that overexpress a protein called FGFR2b. The main goal of using bemarituzumab is to help treat these cancers when combined with a specific chemotherapy regimen known as FLOT. At the molecular level, bemarituzumab works by targeting and blocking the FGFR2b protein, which can help slow down or stop the growth of cancer cells. It is classified as a monoclonal antibody, a type of drug designed to target specific proteins in the body.

Investigated diseases

  • Gastric Adenocarcinoma

    Gastric adenocarcinoma is a type of cancer that originates in the glandular cells of the stomach lining. It typically begins in the innermost layer of the stomach and can gradually invade deeper layers. As the disease progresses, it may spread to nearby lymph nodes and other organs. The growth of the tumor can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain. Over time, the cancer can metastasize to distant parts of the body. The progression of the disease can vary depending on the individual and specific characteristics of the tumor.

  • Gastro-oesophageal Junction Adenocarcinoma

    Gastro-oesophageal junction adenocarcinoma is a cancer that occurs where the esophagus meets the stomach. It arises from the glandular cells in this region and can grow into the surrounding tissues. As the tumor enlarges, it may cause symptoms like difficulty swallowing, chest pain, and unintentional weight loss. The cancer can spread to nearby lymph nodes and other organs as it advances. This type of adenocarcinoma can also metastasize to distant sites in the body. The rate of progression can differ based on various factors, including the tumor's characteristics and the patient's overall health.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514078-29-00Protocol codeICO-2023-10Estimated enrolment49 patientsSponsorInstitut De Cancerologie De L Ouest

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).