RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan
Active, not recruiting
- Conditions
- Pancreatic Cancer Metastatic
- Registration Number
- NCT06155136
- Lead Sponsor
- Servier Affaires Médicales
- Brief Summary
The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI
- Detailed Description
The objectives on patients still alive one year after the first cycle of nal-IRI :
* Characterize mPDAC patient population according to their demographics
* Identify PDAC treatment by line of treatment from diagnosis to last treatment
* Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 163
Inclusion Criteria
- Age ≥ 18 years (≥ 19 years in South Korea)
- Cytologically confirmed mPDAC at initiation of the nal-IRI treatment
- All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen
- Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021)
- At least one cycle of nal-IRI-containing regimen should have been administered
- A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen)
- Availability of data related to survival outcomes in the patient medical record
- Patients deceased or not at the time of enrollment will be eligible for inclusion in the study
Exclusion Criteria
- No documentation of systemic therapy outcomes or prior treatments in patient medical records
- Patients with second concomitant metastatic malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease characteristic according to age Through study completion (approximatively 5 months) Tumor stage (localized/locally advanced/metastatic)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinikum der Universität München, - Anstalt des öffentlichen Rechts -
🇩🇪Munich, Germany