Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Study ID
- NCT05074589
- Phase
- PHASE3
- Status
- Completed
Conditions
- Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan liposome、5-Fluorouracil、Leucovorin — DRUGIrinotecan liposome、5-Fluorouracil、Leucovorin
- Placebo、5-Fluorouracil、Leucovorin — DRUGPlacebo、5-Fluorouracil、Leucovorin
Study Details
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.
Key Dates
- Start date
- Jan 25, 2018
- Status verified
- Aug 2023
- Primary completion
- Nov 18, 2021
- Completion
- Mar 10, 2022
Study Design
- Enrollment
- 298 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment group AIrinotecan liposome plus 5-fluorouracil, Leucovorin
- Active Comparator: Treatment group BPlacebo plus 5-fluorouracil, Leucovorin
Primary Outcome Measure
Overall Survival(OS) [ Time Frame: The maximum time in follow up was approximately 12 months ]