OncoMatch/Clinical Trials/NCT07270991
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Is NCT07270991 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including trifluridine/tipiracil and fruquintinib for metastatic oesogastric adenocarcinoma.
Treatment: trifluridine/tipiracil · fruquintinib — 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 treatments are used. The most common is chemotherapy with paclitaxel + ramucirumab, which blocks the tumor's blood supply. These drugs extend survival, but usually only by a few months. For patients who need a third option, the oral drug trifluridine/tipiracil (TAS-102) can provide extra time, though benefits remain limited. That's why researchers are now exploring combinations. Since stomach tumors rely on forming new blood vessels, combining trifluridine/tipiracil with anti-angiogenic drugs - medicines that cut off the tumor's blood supply - looks promising. One of the most exciting of these drugs is fruquintinib, already proven effective in colorectal cancer. A new international trial, FRUQUITAS (ENGIC 06/PRODIGE 114), is now testing whether adding fruquintinib to trifluridine/tipiracil can improve survival for patients with advanced stomach or gastro-esophageal cancer.
Check if I qualifyExtracted eligibility criteria
Disease stage
Metastatic disease required
Histologically proven metastatic adenocarcinoma
Performance status
WHO 0–1
Prior therapy
Must have received: platinum-based chemotherapy (oxaliplatin, cisplatin) — metastatic
Prior treatment (progression or intolerance) with platinum salts (oxaliplatin or cisplatin)
Must have received: fluoropyrimidine — metastatic
Prior treatment (progression or intolerance) with...fluoropyrimidine
Must have received: irinotecan — metastatic
Prior treatment (progression or intolerance) with...irinotecan
Must have received: taxane — metastatic
Prior treatment (progression or intolerance) with...taxane
Cannot have received: trifluridine/tipiracil (trifluridine/tipiracil)
Prior treatment with trifluridine/tipiracil
Cannot have received: fruquintinib (fruquintinib)
Prior treatment with fruquintinib
Cannot have received: regorafenib (regorafenib)
Prior treatment with regorafenib
Cannot have received: anti-VEGFR tyrosine kinase inhibitor
Prior treatment with any anti-VEGFR tyrosine kinase inhibitor
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, hemoglobin ≥ 9 g/dL, platelets ≥ 100 G/L
Kidney function
creatinine clearance > 30 mL/min (CKD EPI)
Liver function
AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), total bilirubin ≤ 1.5 x ULN
Cardiac function
Severe cardiac disorders (including but not limited to acute myocardial infarction, stroke, unstable angina, NYHA class III/IV heart failure, or LVEF<50%) within 6 months [excluded]
Adequate organ function: ANC ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, platelets ≥ 100 G/L, AST/ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastase(s)), total bilirubin ≤ 1.5 x ULN, creatinine clearance > 30 mL/min (CKD EPI). Severe cardiac disorders (including but not limited to acute myocardial infarction, stroke, unstable angina, NYHA class III/IV heart failure, or LVEF<50%) within 6 months [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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