Irinotecan Hydrochloride Liposome Injection (II) in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer: an Open, Randomized, Multicenter Phase III Trial.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• ECOG performance status 0 or 1
• Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease.
• Life expectancy of greater than or equal to3 months.
• At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
• Able and willing to provide a written informed consent
Locations
Other Locations
China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Zengquan Gu
zengquan.gu@hengrui.com
0518-82342973
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2028-12
Participants
Target number of participants: 662
Treatments
Experimental: Treatment group A
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
Active_comparator: Treatment group B
nab-paclitaxel in combination with gemcitabine
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.