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

Pancreatic Cancer Clinical Trial

— MA-PC-RWS-011  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375473
• Other study ID #: MA-PC-RWS-011
• Status: Not yet recruiting
• Start date: April 19, 2024
• Est. completion date: April 19, 2027

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Taiping Zhang, doctor
• Phone: +86 13520132976
• Email: tpingzhang[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: April 19, 2027
• Est. primary completion date: April 19, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Irinotecan liposome II combination therapy regimen
Irinotecan liposome II combination therapy regimen

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rwTEAE	real word treatment emergent adverse event	3 years
Secondary	OS	real word overall survival	3 years
Secondary	PFS	real word progression free survival	3 years
Secondary	ORR	real word objective response rate	3 years
Secondary	TTP	real word time to progression	3 years
Secondary	DCR	real word disease control rate	3 years