This clinical trial is focused on studying a type of cancer known as Advanced Gastric or Gastroesophageal Junction Cancer that shows a specific characteristic called FGFR2b overexpression. The study is testing a new treatment called Bemarituzumab, also known by its code name AMG 552, in combination with a group of chemotherapy drugs. These chemotherapy drugs include Oxaliplatin, Folinic Acid, and Fluorouracil. The trial will compare the effects of this combination against a placebo combined with the same chemotherapy drugs.
The purpose of the study is to see if the combination of Bemarituzumab and chemotherapy can improve the overall survival of patients with this type of cancer. Participants in the study will receive either the new treatment or the placebo, and their health will be monitored over time to assess the treatment’s effectiveness. The study will involve regular check-ups and assessments to track the progress of the disease and any side effects from the treatment.
Throughout the study, participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The trial aims to provide valuable information on whether this new treatment can offer better outcomes for patients with Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b overexpression. The study is expected to continue until 2025, allowing researchers to gather comprehensive data on the treatment’s impact.
1joining the study
Upon joining the study, participation begins with the administration of informed consent. This ensures understanding of the study’s purpose and procedures.
2initial assessment
An initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Tests are performed to ensure adequate organ function and to confirm the presence of FGFR2b overexpression in the tumor.
3randomization
Participants are randomly assigned to one of two groups: one receiving bemarituzumab plus chemotherapy, and the other receiving a placebo plus chemotherapy.
4treatment administration
Treatment involves the administration of bemarituzumab or placebo, along with chemotherapy drugs oxaliplatin, folinic acid, and fluorouracil.
All medications are given through intravenous infusion. The specific dosage and frequency are determined by the study protocol.
5ongoing monitoring
Regular monitoring is conducted to assess the response to treatment and to identify any side effects.
This includes physical examinations, blood tests, and imaging studies as needed.
6completion of treatment
Treatment continues until disease progression, unacceptable side effects, or completion of the study period.
Participants are followed up to assess overall survival and response to treatment.
7final assessment
A final assessment is conducted to evaluate the overall outcome of the treatment.
This includes a review of any changes in health status and quality of life.
Who Can Join the Study?
The person must agree to participate and sign a consent form before any study activities begin.
The person must be at least 18 years old or the legal adult age in their country, whichever is older.
The person must have a specific type of stomach cancer or cancer where the stomach meets the esophagus, confirmed by a tissue sample. This cancer cannot be cured with surgery.
The cancer must be advanced, meaning it cannot be removed by surgery, has spread locally, or has spread to other parts of the body.
The cancer must show a certain level of a protein called FGFR2b in at least 10% of the tumor cells, determined by a special test.
The person must be able to perform daily activities with little or no assistance, as measured by a scale called the ECOG performance status, which should be 0 or 1.
The person must have organs that are working well enough, with specific blood counts and liver and kidney function levels within acceptable ranges.
The person must have cancer that can be measured or evaluated using a standard method called RECIST v1.1.
The person must not have any medical reasons that would prevent them from receiving a type of chemotherapy called mFOLFOX6.
Who Cannot Join the Study?
Patients who have already received treatment for their advanced stomach cancer or cancer at the junction of the stomach and esophagus cannot participate. Advanced means the cancer has spread beyond its original location.
Patients whose cancer does not show a specific characteristic called FGFR2b overexpression are not eligible. FGFR2b overexpression means that the cancer cells have a high amount of a certain protein on their surface.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
Bemarituzumab is a medication being studied for its potential to treat advanced gastric or gastroesophageal junction cancer. It works by targeting a specific protein called FGFR2b, which is found in higher amounts in some cancer cells. By blocking this protein, bemarituzumab may help slow down or stop the growth of cancer cells.
Chemotherapy in this trial refers to a combination of cancer-fighting drugs used to kill or stop the growth of cancer cells. The specific regimen used in this study is called mFOLFOX6, which includes a mix of different chemotherapy drugs. These drugs work together to attack cancer cells in various ways, aiming to improve the patient’s overall survival.
Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression – This is a type of cancer that occurs in the stomach or the area where the stomach meets the esophagus. It is characterized by the overexpression of the FGFR2b protein, which can promote cancer cell growth. The disease typically progresses as cancer cells multiply and spread to nearby tissues and potentially to other parts of the body. Symptoms may include difficulty swallowing, weight loss, and stomach pain. As the cancer advances, it can lead to more severe symptoms and complications. The progression of the disease can vary based on individual factors and the specific characteristics of the cancer.
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