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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Cjmtdb Lppz Bidxum	Lyon	France
Ipbxgkdk Pykovkjxwhwijpw Cyaaew Cpmtut	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

Adenocarcinoma gastric

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 ID:

2024-514078-29-00

Protocol code:

ICO-2023-10

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Bemarituzumab and FLOT Chemotherapy for Patients with Resectable Gastric and Gastroesophageal Junction Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?