Real World Efficacy, Safety Of Nanoliposomal Irinotecan With Fluorouracil And Folinic Acid In Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy

Study Overview

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

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

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

Pancreatic Adenocarcinoma Metastatic

CHUBX 2023/14

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-08-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-11
First Submitted that Met QC Criteria 2023-08-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-12
First Posted (ACTUAL) 2023-08-23	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: naliri Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy

Primary Outcome Measures	Measure Description	Time Frame
Overall survival		Up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
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
Progression-free survival		Every 3 months up to 3 years
Cost evaluation	number of vials per patient	Every 3 months up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Servier

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record