Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer

Phase 2 Recruiting 118 enrolled UNICANCER Servier · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.

Timeline

Start: 2023-06-23
Primary completion: 2026-01
Completion: 2027-01

Publications

Botsen D, Chabaud S, Perrier H, Ammarguellat H, Jestin-Le-Tallec V, Olesinski J, Toullec C, Aparicio T, Ben Abdelghani M, Borg C, Bouche O, Coutzac C, Devaud H, Di Fiore F, Dubreuil O, Evesque L, Huguenin B, Muller M, Poureau PG, Oularue E, Tougeron D, Zaanan A, Ammari S, De Sousa Carvalho N, Decazes P, De La Fouchardiere C. Trifluridine/tipiracil + oxaliplatin +/- nivolumab vs FOLFOX +/- nivolumab in HER2 negative advanced oesogastric adenocarcinoma: The PRODIGE73-UCGI40-LOGICAN trial. Dig Liver Dis. 2024 Aug;56(8):1281-1287. doi: 10.1016/j.dld.2024.04.032. Epub 2024 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	1000 mg/m2	—
Comparator	Leucovorin	Small molecule	200 mg/m2	—
Comparator	Leucovorin	Small molecule	400 mg/m2	—
Subject	Nivolumab	Monoclonal antibody	240 mg	—
Subject	Oxaliplatin	Small molecule	70 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Trifluridine/Tipiracil	Unknown	35 mg/m2	—
Comparator	fluorouracil	Small molecule	400 mg/m2	—
Comparator	fluorouracil	Small molecule	2400 mg/m2	—

Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer

Summary

Timeline

Publications

Drugs

Indications