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Real-world evidence on patients with metastatic pancreatic ductal adenocarcinoma (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
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051641
Enrollment
50
Registered
2023-07-18
Start date
2023-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Metastatic pancreatic ductal adenocarcinoma (mPDAC)

Interventions

None listed

Sponsors

Servier Affaires Medicales
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult Patients must meet all the following inclusion criteria to be eligible for the study: 1. 18 years and older (19 years and older for South Korea) 2. Cytologically confirmed mPDAC at initiation of nal-IRI treatment 3. All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen 4. Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021) 5. At least one cycle of nal-IRI-containing regimen should have been administered 6. A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen) 7. Availability of data related to survival outcomes in the patient medical record 8. Patients deceased or not at the time of enrollment will be eligible for inclusion in the study

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will not be included in the study: 1. No documentation of systemic therapy outcomes or prior treatments in patient medical records 2. Patients with second concomitant metastatic malignancy

Design outcomes

Primary

MeasureTime frame
Not Applicable as data collection is performed to describe population, disease and treatment characteristics.

Secondary

MeasureTime frame
Not Applicable as data collection is performed to describe population, disease and treatment characteristics.

Countries

Japan,Asia(except Japan),Europe

Contacts

Public ContactSatoko Otani

Linical Co., Ltd. Contract Medical Affairs Business unit

otani-satoko@linical.co.jp03-6215-8005

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026