Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic O
Advanced cancer of the stomach and the gastro-esophageal junction (G/GEJ) remains a very serious disease. Today, only about 10-15% of patients are alive after 5 years. Treatments mainly aim to control symptoms, extend life, and maintain quality of life. First treatments usually combine two chemotherapies, but recent ye
| Condition(s) | Metastatic Oesogastric Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Advanced cancer of the stomach and the gastro-esophageal junction (G/GEJ) remains a very serious disease. Today, only about 10-15% of patients are alive after 5 years. Treatments mainly aim to control symptoms, extend life, and maintain quality of life. First treatments usually combine two chemotherapies, but recent years have brought real progress. Immunotherapy - drugs that "unlock" the immune system - has shown clear benefits. For patients whose tumors have certain markers (like PD-L1), combining drugs such as nivolumab or pembrolizumab with chemotherapy can help patients live longer. Another breakthrough is zolbetuximab, a targeted therapy that attacks a protein (Claudin 18.2) found on many gastric cancers, also improving survival. When cancer grows despite these therapies, second-line |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years (patients enrolled gender independently). 2. Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus. 3. Prior treatment by two or three lines of treatment for metastatic setting (patients who received adjuvant therapy and developed metastatic disease within 6 months of completing treatment should be considered as having failed first-line therapy for metastatic disease). 4. Prior treatment (progression or intolerance) with platinum salts (oxaliplatin or cisplatin), fluoropyrimidine and irinotecan and/or taxane (+/- anti-HER2 agents +/- immune checkpoint inhibitors +/- ramucirumab +/- anti-claudin 18.2). 5. Measurable or non-measurable lesions. (Response Evaluation Criteria in Solid Tumors (RECIS |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Federation Francophone de Cancerologie Digestive |
| Locations | Aurillac, France; Avignon, France; Bayeux, France; Bayonne, France; Bayonne, France; Bezannes, France (+58 more sites) |
| Start date | 2025-12-15 |
| NCT ID | NCT07270991 |
| Official listing | https://clinicaltrials.gov/study/NCT07270991 |