Clinical trialObsCompleted
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
- Outcome
- Finished, no results posted
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- 6 October 2023
- Expected end
- 31 October 2023
- Enrollment
- 58 participants
- Sites
- 1
- Primary outcomes
- Overall survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 12 January 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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