NCT06571461

Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Irinotecan	Liposomal Irinotecan：i.v. infusion
DRUG	Oxaliplatin	Oxaliplatin;：i.v. infusion
DRUG	S-1	S-1: Oral
DRUG	Gemcitabine	Gemcitabine: i.v. infusion
DRUG	Capecitabine	Capecitabine: Oral

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-01-01
• Completion: 2029-03-01
• First posted: 2024-08-26
• Last updated: 2024-08-27