Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma

Summary

The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy. The hypotheses are as follows: H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected.

Timeline

Start

2019-03-07

Primary completion

2024-04-15

Completion

2024-09-29

Publications

• Background Randrian V, Adenis A, Desrame J, Barbier E, Di Fiore F, Lievre A, Dahan L, Laurent-Puig P, Mineur L, Breysacher G, Roquin G, Louafi S, Lopez A, Louvet C, Borg C, Metges JP, Faroux R, Gaba L, Manfredi S, Tougeron D. Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre, randomised, non-comparative phase II study. Dig Liver Dis. 2020 Mar;52(3):347-350. doi: 10.1016/j.dld.2019.11.014. Epub 2019 Dec 30.
• Tougeron D, Mineur L, Zaanan A, Kadi M, Poisson Ligeza C, Bourgeois V, Martin-Babau J, Fadin A, Jestin le Tallec V, Ly Lebrun V, Dubreuil O, Khemissa Akouz F, Thimonier E, Bouche O, Lievre A, Di Fiore F, Lecomte T, Lepage C, Hautefeuille V; PRODIGE 62-FFCD 1701-OESIRI investigators/collaborators. Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (PRODIGE 62-FFCD 1701-OESIRI). Eur J Cancer. 2025 Oct 1;228:115741. doi: 10.1016/j.ejca.2025.115741. Epub 2025 Aug 22.

Drugs

Indications