A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors

Summary

This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.

Timeline

Start

2016-05-05

Primary completion

2018-06-06

Completion

2018-06-06

Publications

• Ji D, Shen W, Li T, Wang H, Bai J, Cao J, Hu X. Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. Invest New Drugs. 2024 Aug;42(4):462-470. doi: 10.1007/s10637-024-01442-2. Epub 2024 Jul 22.

Drugs

Indications