Treatment Of Irinotecan Hydrochloride Liposome Injection II In China: A Real World Study Of Pancreatic Cancer Patients

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Irinotecan liposome II combination therapy regimen

MA-PC-RWS-011

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-04-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-16
First Submitted that Met QC Criteria 2024-04-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-19
First Posted (ACTUAL) 2024-04-19	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: prospective observational study Irinotecan liposome II combination therapy regimen	DRUG: Irinotecan liposome II combination therapy regimen Irinotecan liposome II combination therapy regimen
: Retrospective observational study Irinotecan liposome II combination therapy regimen

Participant Group/Arm

Intervention/Treatment

: prospective observational study

Irinotecan liposome II combination therapy regimen

DRUG: Irinotecan liposome II combination therapy regimen

Irinotecan liposome II combination therapy regimen

: Retrospective observational study

Irinotecan liposome II combination therapy regimen

Primary Outcome Measures	Measure Description	Time Frame
rwTEAE	real word treatment emergent adverse event	3 years

Secondary Outcome Measures	Measure Description	Time Frame
OS	real word overall survival	3 years
PFS	real word progression free survival	3 years
ORR	real word objective response rate	3 years
TTP	real word time to progression	3 years
DCR	real word disease control rate	3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Taiping Zhang, doctor

Phone Number: +86 13520132976

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Taiping Zhang, doctor, Peking Union Medical College Hospital, Beijing, China

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record