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

Pancreatic Adenocarcinoma Metastatic Clinical Trial

— NALIRI-PANC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06006728
• Other study ID #: CHUBX 2023/14
• Status: Completed
• Start date: October 6, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma Metastatic

Locations

Country	Name	City	State
France	CHU Bordeaux	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Servier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 3 years
Secondary	Response rate to treatment	Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI).; Duration of treatment is calculated from the day of nal-IRI initiation to the day of disease progression, switch to other treatment regimens or when the patient is lost to follow-up.; Tumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9.	Every 3 months up to 3 years
Secondary	Progression-free survival		Every 3 months up to 3 years
Secondary	Cost evaluation	number of vials per patient	Every 3 months up to 3 years