A randomized phase II study comparing liposomal irinotecan + fluorouracil + levofolinate to FOLFIRINOX as second-line chemotherapy for pancreatic cancer (NUPAT-09 trial)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041200082

Enrollment

Registered

2020-12-24

Start date

2020-12-24

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

1. FF+nal-IRI arm Irinotecan liposome formulation (70 mg/m2 as irinotecan), levofolinate 200 mg/m2, fluorouracil 2400 mg/m2 for 46 hours, every 2 weeks. 2. FOLFIRINOX arm Oxaliplatin 85 mg/m2, irinote

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Advanced or recurrent pancreatic cancer treated with primary chemotherapy including gemcitabine 2. ECOG performance status 0 or 1 3. Neutrophil count >= 2,000/mm3 4. Platelet count >= 100,000/mm3 5. Total bilirubin >= upper limit of normal x 1.5

Exclusion criteria

Exclusion criteria: 1. Complications of infectious diseases 2. Serious cardiac disease or a history of such disease 3. Intestinal paralysis or intestinal obstruction 4. Interstitial pneumonia or pulmonary fibrosis 5. Massive ascites or pleural effusions 6. Severe dysesthesia or sensory deficiency with functional impairment 7. A history of hypersensitivity to oxaliplatin or other platinum-containing drugs, irinotecan, liposomal irinotecan, fluorouracil, or levofolinate. 8. Pregnant women or women who may be pregnant 9. Patients on atazanavir sulfate

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Progression free survival, time to treatment failure and response rate	—

Contacts

Public ContactOsamu Maeda

Nagoya University Hospital

maeda-o@med.nagoya-u.ac.jp+81-52-744-1903

Outcome results

None listed

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