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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06375473
Other study ID # MA-PC-RWS-011
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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