Ongoing Clinical Trials for Recurrent Gastric Cancer
There is currently 1 ongoing clinical trial for patients with recurrent gastric cancer. This trial is investigating a new treatment combination involving Trastuzumab Deruxtecan (Enhertu®) for patients with advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer. The study is being conducted across multiple European countries and compares this new approach to current standard treatments.
Clinical trial locations
- Austria
- Belgium
- Czechia
- France
- Germany
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
This clinical trial is exploring new treatment options for patients with HER2-positive cancer affecting the stomach or the area where the stomach meets the esophagus. The study focuses on comparing a new treatment combination involving Trastuzumab Deruxtecan, also known as Enhertu®, with current standard treatments.
Main focus: The trial aims to determine how effective Trastuzumab Deruxtecan is when combined with chemotherapy, with or without the addition of Pembrolizumab. This combination will be compared to the current standard treatment, which includes chemotherapy and Trastuzumab, with or without Pembrolizumab. The study is designed for patients who have not yet received treatment for their advanced cancer and will last up to 60 weeks. During this time, participants will be closely monitored through regular clinic visits, imaging tests such as CT or MRI scans, and questionnaires about their well-being.
Investigational drugs: The trial uses three main medications. Trastuzumab Deruxtecan is an antibody-drug conjugate that targets the HER2 protein on cancer cells and delivers chemotherapy directly to them. Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells. Trastuzumab also targets the HER2 protein to slow down or stop cancer cell growth. These medications are given through intravenous infusion directly into the bloodstream, with some treatments taken orally as pills.
Who can participate – inclusion criteria:
- You must be at least 18 years old
- You must have HER2-positive stomach or gastroesophageal junction cancer that is advanced and cannot be removed by surgery
- You should not have received previous treatment for your advanced cancer
- Your organs and bone marrow must be functioning adequately
- You must have at least one measurable tumor that can be seen on imaging scans
- Your heart must be functioning well, with a Left Ventricular Ejection Fraction of at least 50 percent
- You must be fully active or have only minor symptoms that do not require daytime bed rest
- You must provide a tumor sample for testing to confirm HER2 and PD-L1 status
- If you can have children, you must agree to use effective birth control during the trial and for several months after the last treatment dose
- You must be willing to attend all scheduled visits and complete required tests and questionnaires
Who cannot participate – exclusion criteria:
- Patients with other types of cancer not related to this study
- Patients who have had recent cancer treatment within a specified time period
- Patients with serious heart problems or uncontrolled high blood pressure
- Patients with active infections requiring treatment
- Patients who are pregnant or breastfeeding
- Patients with allergies to the study medications or a history of severe allergic reactions
- Patients with a history of drug or alcohol abuse
- Patients who are unable to follow the study procedures
Summary
Currently, there is one active clinical trial available for patients with recurrent gastric cancer. This trial is conducted across 12 European countries, including Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Romania, and Spain, providing broad access for European patients.
The study is specifically designed for patients with HER2-positive cancer, which means the cancer cells have higher levels of the HER2 protein. The trial focuses on evaluating a new antibody-drug conjugate called Trastuzumab Deruxtecan in combination with other treatments, comparing it to current standard care options.
What makes this trial particularly notable is its focus on patients who have not yet received treatment for their advanced cancer, offering them access to potentially innovative therapeutic approaches. The wide geographical distribution across Europe reflects a collaborative effort to advance treatment options for this specific type of cancer.
