Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2026
FRUQUITAS trial: Study design of an ENGIC intergroup randomized phase III of trifluridine/tipiracil +/- fruquintinib in pre-treated metastatic gastro-oesophageal adenocarcinoma.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Tougeron David, Rivera Fernando, Kanonnikoff Tania Fleitas, Le Malicot Karine, Guarssifi Meriem, Fares Nadim, Soularue Emilie, Dos Santos Melanie, Wagner Mathilde, Taieb Julien, Aparicio Thomas, Laurent-Puig Pierre, Hacker Ulrich T, Fernández Montes Ana, Al-Batran Salah-Eddin, Lordick Florian
Аннотация
BACKGROUND: Prognosis of metastatic oesogastric adenocarcinoma (mOGC) beyond second‑line therapy remains poor. Trifluridine/tipiracil monotherapy is recommended in later lines but provides limited survival benefits. Anti‑angiogenic drugs have demonstrated significant efficacy in mOGC. Fruquintinib is a selective VEGFR‑1, ‑2 and ‑3 inhibitor with demonstrated activity in refractory colorectal adenocarcinoma. This design paper reports the rationale and design of the academic ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS trial within the European network in gastro-intestinal oncology intergroup (ENGIC).
METHODS: ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS is an international, multicentre, open‑label, randomized phase III trial comparing trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil alone in patients with metastatic oesophageal, gastro-oesophageal junction or gastric adenocarcinoma previously treated with two or three treatment lines. Patients are randomized 1:1 and stratified by treatment line, time from metastatic diagnosis to randomization, WHO performance status and prior anti‑angiogenic exposure. The primary endpoint is overall survival. Secondary endpoints include progression‑free survival, time to progression, objective response rate, disease control rate, safety, quality of life and translational biomarker analyses.
PERSPECTIVES: ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS is designed to determine whether VEGFR inhibition with fruquintinib plus trifluridine/tipiracil can meaningfully improve survival outcomes in pre-treated mOGC.
TRIAL REGISTRATION: EU CT number 2025‑522395‑92‑00.
METHODS: ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS is an international, multicentre, open‑label, randomized phase III trial comparing trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil alone in patients with metastatic oesophageal, gastro-oesophageal junction or gastric adenocarcinoma previously treated with two or three treatment lines. Patients are randomized 1:1 and stratified by treatment line, time from metastatic diagnosis to randomization, WHO performance status and prior anti‑angiogenic exposure. The primary endpoint is overall survival. Secondary endpoints include progression‑free survival, time to progression, objective response rate, disease control rate, safety, quality of life and translational biomarker analyses.
PERSPECTIVES: ENGIC 06 - PRODIGE 114 - FFCD 2401 - FRUQUITAS is designed to determine whether VEGFR inhibition with fruquintinib plus trifluridine/tipiracil can meaningfully improve survival outcomes in pre-treated mOGC.
TRIAL REGISTRATION: EU CT number 2025‑522395‑92‑00.
Предметные рубрики MeSH
HumansAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsEsophageal NeoplasmsEsophagogastric JunctionPyrrolidinesQuinazolinesResearch DesignStomach NeoplasmsThymineTrifluridineUracilRandomized Controlled Trials as TopicClinical Trials, Phase III as TopicMulticenter Studies as TopicBenzofurans