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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06375473
Acronym
MA-PC-RWS-011
Enrollment
3000
Registered
2024-04-19
Start date
2024-04-19
Completion date
2027-04-19
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

real word study, irinotecan hydrochloride liposome injection II, pancreatic cancer

Brief 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.

Interventions

Irinotecan liposome II combination therapy regimen

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
rwTEAE3 yearsreal word treatment emergent adverse event

Secondary

MeasureTime frameDescription
OS3 yearsreal word overall survival
PFS3 yearsreal word progression free survival
ORR3 yearsreal word objective response rate
TTP3 yearsreal word time to progression
DCR3 yearsreal word disease control rate

Countries

China

Contacts

Primary ContactTaiping Zhang, doctor
tpingzhang@yahoo.com+86 13520132976

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026