HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate Versus Nab-paclitaxel in Combination With Gemcitabine for First-line Treatment of Advanced 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
The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic 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
RECRUITING
Beijing
Contact Information
Primary
Jun Zhang
Jun.zhang@hengrui.com
0518-82342973
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 778
Treatments
Experimental: HR070803; Oxaliplatin; 5Fluorouracil; Calcium folinate
Active_comparator: nab-paclitaxel; gemcitabine
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.