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

December 31, 2025 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

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

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Unicersity First Hospital
        • Contact:
      • Henan, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:
          • Xu Jin
      • Shanghai, China
        • Recruiting
        • Renji，Hospital
        • Contact:
      • Wuhan, China
        • Recruiting
        • Wuhan Union Hospital of China
        • Contact:
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pancreatic cancer patients in China

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Perioperative cohort
Irinotecan liposome II combination therapy regimen for perioperative patients
Drug: Irinotecan liposome II combination therapy regimen
Irinotecan liposome II combination therapy regimen
First line cohort
Irinotecan liposome II combination therapy regimen for first line advanced patients
Second line cohort
Irinotecan liposome II combination therapy regimen for second line advanced patients
Late stage third line and above cohort
Irinotecan liposome II combination therapy regimen for third line and above advanced patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Taiping Zhang, doctor, Peking Union Medical College Hospital, Beijing, China
  • Principal Investigator: Liwei Wang, doctor, Renji Hospital, Shanghai, China

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 Major Dates

Study Start (Actual)

April 19, 2024

Primary Completion (Estimated)

April 19, 2027

Study Completion (Estimated)

April 19, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-PC-RWS-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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