NalIriFOx as first-line therapy for metastatic pancreatic cancer
Official title: Hellenic Evaluation of the Long-Term Safety and Efficacy of NalIriFOx as a 1st-line Therapy in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Run by Hellenic Cooperative Oncology Group · NCT07723261 · Data updated 2026-11-12
This real-world study will see how NalIriFOx performs as a first-line treatment for metastatic pancreatic cancer in several Greek centers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Hellenic Cooperative Oncology Group Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Athens and 8 other locations) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | March 30, 2029 |
| Study ends | March 30, 2029 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07723261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients with metastatic pancreatic ductal adenocarcinoma who start NalIriFOx as their first systemic therapy and can provide informed consent.
✕Probably not a fit
Patients who do not receive any clinical benefit or who discontinue NalIriFOx early due to intolerance or progression may not experience measurable benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, prospective, open-label, non-interventional study collects real-world data on the safety and clinical activity of NalIriFOx as a first-line option for metastatic PDAC. The analysis will describe patient outcomes, including tolerability and any adverse events, in routine clinical practice. No randomization or experimental interventions are planned beyond standard-of-care use of NalIriFOx. The study aims to complement existing evidence from controlled trials by capturing how NalIriFOx behaves in a broader patient population. Enrollment is limited to patients who are treated with NalIriFOx as their initial systemic therapy and can provide informed consent.
Why it matters
Potential benefit: If successful, the study could confirm NalIriFOx as a feasible first-line option with manageable safety in real-world patients.
How similar studies have gone: Real-world data on NalIriFOx in first-line PDAC is limited; this study adds practical insights but may have heterogeneity and lack of randomized comparison.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically or cytologically proven metastatic PDAC * 1st line treatment with NalIriFOx according to physician's choice * Patients willing to provide a Written Informed Consent Exclusion Criteria: * Patients not matching the above-mentioned inclusion criteria * Neoadjuvant or adjuvant treatment within 6 months from enrolment * Prior treatment with Liposomal irinotecan * Prior treatment of pancreatic cancer in the metastatic setting with chemotherapy or investigational therapy
Where it's running
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Attikon University General Hospital
Athens, Greece Recruiting -
General Oncology Hospital Agioi Anargyroi
Athens, Greece Recruiting -
HYGEIA Hospital
Athens, Greece Recruiting -
HYGEIA Hospital
Athens, Greece Recruiting -
2nd Oncology Department, Metropolitan Hospital
Athens, Greece Recruiting -
Ippokratio
Athens, Greece Recruiting
Show 3 more locations
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Larissa University General Hospital
Larissa, Greece Recruiting -
General Hospital Agios Andreas
Pátrai, Greece Recruiting -
Thessaloniki General Hospital "George Papanikolaou"
Thessaloniki, Greece Recruiting
Study contacts
- Principal investigator: Athina Christopoulou, MD, PhD — Oncology Unit, General Hospital of Patras "Agios Andreas"
- Study coordinator: Ioanna Mitrentsi, PhD
- Email: i_mitrentsi@hecog.ondsl.gr
- Phone: +30 2106912520
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.