NCT05074589

Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer

A Randomized, Double-blind, Single-dummy, Parallel-controlled, Multicentre, Phase III Clinical Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.

Conditions

• Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

Interventions

Type	Name	Description
DRUG	Irinotecan liposome、5-Fluorouracil、Leucovorin	Irinotecan liposome、5-Fluorouracil、Leucovorin
DRUG	Placebo、5-Fluorouracil、Leucovorin	Placebo、5-Fluorouracil、Leucovorin

Timeline

• Start date: 2018-01-25
• Primary completion: 2021-11-18
• Completion: 2022-03-10
• First posted: 2021-10-12
• Last updated: 2023-08-14

Locations

1 site across 1 country: China