RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)

Servier

Status: Active, not recruiting

Conditions: Pancreatic Cancer Metastatic

Study type: Observational

Funder types: Industry

Identifiers

NCT06155136

DIM-95013-001-INT

Details and patient eligibility

About

The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

Full 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

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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