Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Irinotecan liposome II combination therapy regimen

• Registration Number: NCT06375473
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study Start: 2024-04-19
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2027-04-19
• Study Completion: 2027-04-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients with pancreatic ductal adenocarcinoma diagnosed by pathology or imaging;
• Age ≥18 years old, male or female;
• Patients receiving treatment based on irinotecan hydrochloride liposome injection II;
• The subjects voluntarily joined the study and signed the informed consent.

Exclusion Criteria

• Confirmed pregnant or lactating women;
• The researchers determined that other conditions were not suitable for inclusion in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prospective observational study	Irinotecan liposome II combination therapy regimen	Irinotecan liposome II combination therapy regimen

Primary Outcome Measures

Name	Time	Method
rwTEAE	3 years	real word treatment emergent adverse event

Secondary Outcome Measures

Name	Time	Method
TTP	3 years	real word time to progression
OS	3 years	real word overall survival
PFS	3 years	real word progression free survival
DCR	3 years	real word disease control rate
ORR	3 years	real word objective response rate

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China