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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Pancreatic Adenocarcinoma Metastatic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic adenocarcinoma