NCT06172036

Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab

A Multicenter, Multi-cohort, Randomized, Phase II Study of Irinotecan Liposome Combined With 5-FU / LV and Oxaliplatin for Resectable Pancreatic Cancer With or Without Addebelizumab

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate

Detailed description

For patients with surgically resectable pancreatic cancer who have not received any anti-tumor therapy. To evaluate the efficacy and safety of irinotecan liposomes with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin (LV) with or without adelizumab for resectable pancreatic cancer by assessing the 12-month EFS rate.

Conditions

• Neoadjuvant Chemotherapy
• Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	irinotecan liposome + oxaliplatin + 5-FU / LV	Efficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer
DRUG	Adebellizumab	Efficacy and safety of irinotecan liposome combined with oxaliplatin, 5-fluorouracil (5-FU) / leucovorin calcium (LV) with or without adbellizumab for resectable pancreatic cancer

Timeline

• Start date: 2024-01-20
• Primary completion: 2026-01-20
• Completion: 2027-01-20
• First posted: 2023-12-15
• Last updated: 2023-12-15