Clinical trial

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

Name

MA-PC-RWS-011

Description

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.

Trial arms

Trial start

2024-04-19

Estimated PCD

2027-04-19

Trial end

2027-04-19

Status

Not yet recruiting

Treatment

Irinotecan liposome II combination therapy regimen

Arms:

prospective observational study

Size

3000

Primary endpoint

rwTEAE

3 years

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 3000, 'type': 'ESTIMATED'}}

Updated at

2024-04-19

1 organization

1 product

1 indication

Organization

Peking Union Medical College Hospital

Product

Irinotecan liposome II

Indication

Pancreatic Cancer