Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2024
Trifluridine/tipiracil + oxaliplatin ± nivolumab vs FOLFOX ± nivolumab in HER2 negative advanced oesogastric adenocarcinoma: The PRODIGE73-UCGI40-LOGICAN trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Botsen Damien, Chabaud Sylvie, Perrier Hervé, Ammarguellat Hanifa, Jestin-Le-Tallec Véronique, Olesinski Jonathan, Toullec Clémence, Aparicio Thomas, Ben Abdelghani Meher, Borg Christophe, Bouche Olivier, Coutzac Clélia, Devaud Hervé, Di Fiore Frédéric, Dubreuil Olivier, Evesque Ludovic, Huguenin Bruno, Muller Marie, Poureau Pierre-Guillaume, Oularue Emilie, Tougeron David, Zaanan Aziz, Ammari Samy, De Sousa Carvalho Nicolas, Decazes Pierre, De La Fouchardiere Christelle
Аннотация
BACKGROUND: Trifluridine/tipiracil (FTD/TPI) is approved in third-line treatment of patients with advanced/metastatic gastric and gastroesophageal junction adenocarcinomas (aGA/GEJA). The association of oxaliplatin with FTD/TPI is promising and the combination of FTD/TPI + oxaliplatin + nivolumab has shown a predictable and manageable safety profile.
AIMS: The aim is to evaluate the efficacy and safety of FTD/TPI plus oxaliplatin with or without nivolumab in patients, with HER2 negative aGA/GEJA, unfit for triplet chemotherapy (TFOX/mFLOT regimen), in the first-line metastatic setting in comparison with the standard of care FOLFOX with or without nivolumab.
METHODS: This study is a prospective randomised, open label, comparative, multicentre, phase II trial designed to include 118 patients. The primary objective is to evaluate the superiority of FTD/TPI plus oxaliplatin with or without nivolumab over FOLFOX regimen with or without nivolumab in terms of PFS in a population of patients non candidate for triplet chemotherapy. Nivolumab will be used for patients whose tumour express PD-L1 with a CPS score ≥5.
DISCUSSION: PRODIGE73-UCGI40-LOGICAN study will provide efficacy and safety data on the association of FTD/TPI plus oxaliplatin with or without nivolumab versus FOLFOX regimen with or without nivolumab in first-line palliative setting, in patients with aGA/GEJA (NCT05476796).
AIMS: The aim is to evaluate the efficacy and safety of FTD/TPI plus oxaliplatin with or without nivolumab in patients, with HER2 negative aGA/GEJA, unfit for triplet chemotherapy (TFOX/mFLOT regimen), in the first-line metastatic setting in comparison with the standard of care FOLFOX with or without nivolumab.
METHODS: This study is a prospective randomised, open label, comparative, multicentre, phase II trial designed to include 118 patients. The primary objective is to evaluate the superiority of FTD/TPI plus oxaliplatin with or without nivolumab over FOLFOX regimen with or without nivolumab in terms of PFS in a population of patients non candidate for triplet chemotherapy. Nivolumab will be used for patients whose tumour express PD-L1 with a CPS score ≥5.
DISCUSSION: PRODIGE73-UCGI40-LOGICAN study will provide efficacy and safety data on the association of FTD/TPI plus oxaliplatin with or without nivolumab versus FOLFOX regimen with or without nivolumab in first-line palliative setting, in patients with aGA/GEJA (NCT05476796).
Предметные рубрики MeSH
AdultAgedFemaleHumansMaleMiddle AgedAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsEsophageal NeoplasmsEsophagogastric JunctionFluorouracilLeucovorinMulticenter Studies as TopicNivolumabOrganoplatinum CompoundsOxaliplatinProspective StudiesPyrrolidinesErb-b2 Receptor Tyrosine KinasesStomach NeoplasmsThymineTrifluridineNon-Randomized Controlled Trials as TopicEquivalence Trials as Topic