Hellenic Evaluation of the Long-Term Safety and Efficacy of NalIriFOx as a 1st-line Therapy in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

NCT07723261 | Recruiting

• 1 other identifier: HE3/24
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 9

Brief Summary

This is multicenter, prospective, open label, non-interventional study that will collect real-world data (RWD) on the clinical efficacy and safety of NalIriFOx as a first-line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC).

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

mPDAC; NalIriFOx; safety

Outcome Measures

Primary Outcomes (1)

• Real World Data collection

  Record clinical practice and collect real-world data (RWD) on the clinical efficacy and safety of NalIriFOx as a first-line therapy in mPDAC

  Time from study entry untill completion (12 months)

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 12 months]

• Overall Survival (OS)

  Time from study entry to death from any cause, assessed up to 12 months

Study Arms (1)

mPDAC patients

mPDAC patients receiving NalIriFox as a first line therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mPDAC receiving NalIriFOx as first line therapy

You may qualify if:

• Patients with histologically or cytologically proven metastatic PDAC
• st line treatment with NalIriFOx according to physician's choice
• Patients willing to provide a Written Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (9)

Attikon University General Hospital

Athens, 124 62, Greece

RECRUITING

General Oncology Hospital Agioi Anargyroi

Athens, 145 64, Greece

RECRUITING

HYGEIA Hospital

Athens, 151 23, Greece

RECRUITING

HYGEIA Hospital

Athens, 151 23, Greece

RECRUITING

2nd Oncology Department, Metropolitan Hospital

Athens, 185 47, Greece

RECRUITING

Ippokratio

Athens, Greece

RECRUITING

Larissa University General Hospital

Larissa, Greece

RECRUITING

General Hospital Agios Andreas

Pátrai, 263 32, Greece

RECRUITING

Thessaloniki General Hospital "George Papanikolaou"

Thessaloniki, 570 10, Greece

RECRUITING

Study Officials

• Athina Christopoulou, MD, PhD

  Oncology Unit, General Hospital of Patras "Agios Andreas"

  PRINCIPAL INVESTIGATOR

• George Papaxoinis, MD

  2nd Dept of Medical Oncology, "Agios Savvas" Anti Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioanna Mitrentsi, PhD

CONTACT

+30 2106912520; i_mitrentsi@hecog.ondsl.gr

Maria Moschoni

CONTACT

+30 2106912520; m_moschoni@hecog.ondsl.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): March 30, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

GR (9)