A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced/Metastatic Pancreatic Cancer in China

Not yet recruiting

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: Nal-IRI (Onivyde®)-based treatment; Drug: Other second-line treatment

• Registration Number: NCT07026123
• Lead Sponsor: RenJi Hospital

Brief Summary

This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.

Detailed Description

Chinese patients with pancreatic cancer are mostly treated according to foreign clinical research, lacking the diagnosis and treatment data of efficacy and safety of Chinese population. In the NAPOLI-1 study, irinotecan liposomes (Onivyde®) The combination of 5-fluorouracil and folinic acid (Nal-IRI+5-FU/LV) has shown survival benefits in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have previously received gemcitabine-based treatment. The NAPOLI-3 study showed that NALIRIFOX (Nal-IRI+oxaliplatin+5-FU/LV) significantly improved overall survival (OS) and progression free survival (PFS) compared to albumin bound paclitaxel and gemcitabine in newly diagnosed mPDAC patients. However, the efficacy and safety data of Nal-IRI-based treatment regimens in China are limited. In August 2023, Onivyde® was commercially listed in China. The purpose of this study is to: ① evaluate the real world efficacy and safety of Onivyde®-based treatment schemes in Chinese patients with locally advanced or metastatic pancreatic cancer; ② analyze the efficacy of Onivyde® treatment and the efficacy of all pancreatic cancer patients who have not received relevant treatment using the project data of China Advanced pancreatic cancer Big Data Center (Renji Hospital Cancer Department is the national leading unit), in conjunction with the survival follow-up data of China Center for Disease Control and Prevention of Chronic Non communicable Diseases.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2025-07-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• Confirm pregnant or lactating women.
• The patient's clinical data is not available.
• The researchers determined that they were not suitable for inclusion in the study due to other circumstances.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Nal-IRI (Onivyde®)-based treatment	Liposomal irinotecan (Onivyde®)-based treatment.
Control group	Other second-line treatment	Real medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 24 months	Overall Survival (OS) is defined as the time from enrollment to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 24 months	Progression-Free Survival (PFS) is defined as the time from first-dose to the first documented disease progression or death
Time To Progress (TTP)	Up to 24 months	Time To Progress (TTP) is defined as the length of time from first-dose until the date of disease progression
Overall Response Rate (ORR)	Up to 24 months	Overall Response Rate (ORR) is defined as the percentage of people in this study who have a partial response or complete response (according to RESIST v1.1) to the treatment
Disease Control Rate (DCR)	Up to 24 months	Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response or stable disease, according to RESIST v1.1
Safety and tolerability by incidence, severity and outcome of adverse events	Until 30 day safety follow-up visit	Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China