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| Name | Class |
|---|---|
| Servier | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naliri | Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to 3 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Pessac | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41316032 | Derived | Decraecker M, Le Joncour S, Aurillac V, Sangnier M, Ducerf C, Berroneau A, Rouleau L, Tougeron D, Laplace C, Madau M, Dumon C, Perrier H, Blanc JF. Real-world efficacy of nanoliposomal irinotecan in patients with advanced pancreatic cancer. BMC Cancer. 2025 Nov 28;26(1):3. doi: 10.1186/s12885-025-15346-8. |
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| 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 |