Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irinotecan liposome II combination therapy regimen.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Irinotecan liposome II combination therapy regimen
Irinotecan liposome II combination therapy regimen
Primary outcome measures
- rwTEAE [Time frame: 3 years]
Secondary outcome measures (5)
- OS [Time frame: 3 years]
- PFS [Time frame: 3 years]
- ORR [Time frame: 3 years]
- TTP [Time frame: 3 years]
- DCR [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 10 centers
- Anhui Provincial Cancer Hospital — Hefei
- Peking Union Medical College Hospital — Beijing
- The First Affiliated Hospital of Guangxi Medical University — Nanning
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
- Peking Unicersity First Hospital — Beijing
- Henan Provincial People's Hospital — Henan
- Ningbo Medical Center Lihuili Hospital — Ningbo
- Fudan University Shanghai Cancer Center — Shanghai
- … and 2 more centers
Identifiers
NCT: NCT06375473 · MA-PC-RWS-011