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

Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06155136

Acronym

NALLONG

Enrollment

163

Registered

2023-12-04

Start date

2023-10-06

Completion date

2024-09-30

Last updated

2024-04-22

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

Conditions

Pancreatic Cancer Metastatic

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Disease characteristic according to age	Through study completion (approximatively 5 months)	Tumor stage (localized/locally advanced/metastatic)

Countries

Germany

Outcome results