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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

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Trial Profile

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 of Trial: Phase III

Latest Information Update: 17 Aug 2023

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At a glance

  • Drugs Irinotecan (Primary) ; Fluorouracil; Folinic acid
  • Indications Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Jiangsu Hengrui Medicine Co.
  • Most Recent Events

    • 09 Aug 2023 Status changed from active, no longer recruiting to completed.
    • 13 Sep 2022 Primary endpoint has been met. (Overall Survival(OS)) , according to Results presented at the 47th European Society for Medical Oncology Congress
    • 13 Sep 2022 Results (cutoff date of date: 18 Nov 2021) of an analysis based on 228 deaths presented at the 47th European Society for Medical Oncology Congress

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