Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy (NALIRI-PANC)

University Hospital of Bordeaux

Status: Completed

Conditions: Pancreatic Adenocarcinoma Metastatic

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06006728

CHUBX 2023/14

Details and patient eligibility

About

The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice

Full description

Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial.

Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales.

However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• histological or cytological confirmation of pancreatic ductal adenocarcinoma
• measurable lesion(s)
• progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil.
• Performance Status (PS) 0 or 1
• Oral consent
• Health insurance

Exclusion criteria

• symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)
• thromboembolic events within six months of inclusion;
• Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.
• Patient under legal protection
• Hypersensitivity to irinotecan
• Breast feeding

Trial design

58 participants in 1 patient group

naliri

Description:

Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy