Clinical trial · Observational
Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
NCT06006728CI-TRIAL-00072960NALIRI-PANCcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- naliri
- description
- Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Up to 3 years
Secondary outcomes (3)
- 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). 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDecraecker 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. PMID 41316032