Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients (MA-PC-RWS-011)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Drug: Irinotecan liposome II combination therapy regimen

Study type: Observational

Funder types: Other

Identifiers

NCT06375473

MA-PC-RWS-011

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 4 patient groups

Perioperative cohort

Description:

Irinotecan liposome II combination therapy regimen for perioperative patients

Treatment:

Drug: Irinotecan liposome II combination therapy regimen

First line cohort

Description:

Irinotecan liposome II combination therapy regimen for first line advanced patients

Second line cohort

Description:

Irinotecan liposome II combination therapy regimen for second line advanced patients

Late stage third line and above cohort

Description:

Irinotecan liposome II combination therapy regimen for third line and above advanced patients