This study is looking at metastatic oeso-gastric adenocarcinoma, which is a type of cancer that has spread and affects the stomach, the area where the esophagus meets the stomach, or the esophagus itself. The treatments being tested include trifluridine combined with tipiracil hydrochloride, which is a medicine sold as Lonsurf, and fruquintinib, which is sold as FRUZAQLA. These medicines are taken by mouth as tablets or capsules. The study will compare two treatment approaches: one group will receive Lonsurf together with FRUZAQLA, while another group will receive only Lonsurf. This study includes patients who have already received two or three previous treatments for their cancer that included certain types of chemotherapy medicines.
The main purpose of this study is to find out if adding FRUZAQLA to Lonsurf helps people live longer compared to taking Lonsurf alone. The study will also look at how long patients live without their cancer getting worse, how well the tumors respond to treatment, and how the treatments affect quality of life. The safety of the treatments will be carefully monitored, and any side effects will be recorded. Patients will be assigned randomly to one of the two treatment groups, meaning that neither the patient nor the doctor chooses which treatment is given.
During the study, patients will take their assigned medicines for up to six months, and their health will be regularly checked through medical examinations and scans to see how the cancer is responding. Quality of life will be measured using questionnaires that ask about daily activities and symptoms. The study is expected to start enrolling patients in early 2026 and continue until early 2029. Patients will need to provide tumor tissue samples for testing and agree to participate in additional biological studies as part of the research.
France 
Germany 
Spain 
