A multicenter observational study of Liposomal Irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON 2) (Prospective part)

A multicenter observational study of Liposomal Irinotecan and fluorouracil/leucovorin in patients with unresectable or recurrent pancreatic cancer (NAPOLEON 2) (Prospective part) - NAPOLEON 2 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043939

Enrollment

150

Registered

2021-06-01

Start date

2021-06-01

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

Pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 1. whose unresectable or recurrent pancreatic cancer are judged by abdominal CT. 2. who are going to receive NAL-IRI/FU/LV after at least one regimen. 3. whose tumors are not NET. 4. who submitted ICs. 5. of greater than or equal to 20 years old. 6. with adequate organ functions. 7. with ECOG PS 0-2.

Exclusion criteria

Exclusion criteria: Patients 1. with active double cancers. 2. whom the doctor in-chief judged not to be indicated for this study. 3. who cannot submit ICs. 4. who have allergy for NAL-IRI. 5. who are contraindicated for NAL-IRI.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Response rate, disease control rate, progression-free survival	—

Countries

Japan

Contacts

Public ContactTaiga Otsuka

Minato Medical Clinic Department of Internal Medicine

otsuka-t@umin.ac.jp092-711-6900

Outcome results