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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006728
Collaborator
Servier (Industry)
55
Enrollment
1
Location

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    55 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    naliri

    Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [Up to 3 years]

    Secondary Outcome Measures

    1. Response rate to treatment [Every 3 months up to 3 years]

      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.

    2. Progression-free survival [Every 3 months up to 3 years]

    3. Cost evaluation [Every 3 months up to 3 years]

      number of vials per patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Bordeaux Pessac France

    Sponsors and Collaborators

    • University Hospital, Bordeaux
    • Servier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Bordeaux
    ClinicalTrials.gov Identifier:
    NCT06006728
    Other Study ID Numbers:
    • CHUBX 2023/14
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Bordeaux
    pancreatic adenocarcinoma
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Aug 23, 2023