NCT07238283

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• First-line Treatment of Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate	Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
DRUG	nab-paclitaxel; gemcitabine	nab-paclitaxel in combination with gemcitabine

Timeline

• Start date: 2025-12-02
• Primary completion: 2028-10-01
• Completion: 2028-12-01
• First posted: 2025-11-20
• Last updated: 2025-12-09

Locations

1 site across 1 country: China