OncoMatch/Clinical Trials/NCT07270991
Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma
Is NCT07270991 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Targeted therapy
Other
Cancer type
Esophageal Carcinoma
Gastric Cancer
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.
Frequently asked questions
Is NCT07270991 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior trifluridine/tipiracil, fruquintinib, regorafenib disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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