Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 5:22 AM
Study NCT ID:
NCT06006728
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Response rate to treatment', 'timeFrame': 'Every 3 months up to 3 years', 'description': 'Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI).\n\nDuration 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.\n\nTumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Every 3 months up to 3 years'}, {'measure': 'Cost evaluation', 'timeFrame': 'Every 3 months up to 3 years', 'description': 'number of vials per patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic adenocarcinoma'], 'conditions': ['Pancreatic Adenocarcinoma Metastatic']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nNanoliposomal 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.\n\nHowever, 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient treated with nanoliposomal irinotecan with fluorouracil and folinic acid for metastatic pancreatic adenocarcinoma after progression with gemcitabine-based treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* histological or cytological confirmation of pancreatic ductal adenocarcinoma\n* measurable lesion(s)\n* 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.\n* Performance Status (PS) 0 or 1\n* Oral consent\n* Health insurance\n\nExclusion Criteria:\n\n* symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease)\n* thromboembolic events within six months of inclusion;\n* Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension.\n* Patient under legal protection\n* Hypersensitivity to irinotecan\n* Breast feeding'}, 'identificationModule': {'nctId': 'NCT06006728', 'acronym': 'NALIRI-PANC', 'briefTitle': 'Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy', 'orgStudyIdInfo': {'id': 'CHUBX 2023/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'naliri', 'description': 'Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pessac', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Servier', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}