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

23. juli 2026 opdateret af: Hellenic Cooperative Oncology Group
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).

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Pancreatic cancer is an aggressive malignancy with a dismal prognosis, often diagnosed at an advanced stage where curative treatment options are limited. It is the seventh leading cause of cancer-related deaths globally, with a five-year survival rate of less than 10%.

Progress with systemic therapy for patients with advanced pancreatic cancer has historically been slow. However, therapeutic advances in the past 12 years have resulted in modest yet tangible improvements for patients.

Current first-line treatment options for metastatic pancreatic cancer include combination chemotherapy regimens such as FOLFIRINOX (a combination of folinic acid, fluorouracil, irinotecan, and oxaliplatin) and gemcitabine plus nab-paclitaxel.

FOLFIRINOX has demonstrated significant improvements in overall survival and progression-free survival compared to gemcitabine alone, albeit with increased toxicity. Although FOLFIRINOX has achieved longer median OS compared to gemcitabine - nab-Paclitaxel, its poor toxicity profile made its use very difficult in clinical practice. Therefore, FOLFIRINOX has practically been substituted by the better tolerated modified FOLFIRINOX which has not been formally tested in a randomized clinical trial. Therefore, it remains a need for more effective and better-tolerated first-line therapies for metastatic pancreatic cancer patients.

Liposomal irinotecan or nal-IRI, also known as pegylated liposomal irinotecan and abbreviated as MM-398 or PEP02, has emerged as the only registered post-gemcitabine treatment in mPDAC, often used in the second line after a gemcitabine-based first -line regimen. Nal-IRI is an intravenous liposomal formulation that encapsulates the topoisomerase I inhibitor irinotecan in a lipid-bilayer vesicle.

Nal-IRI was developed to overcome the pharmacological and clinical shortcomings of the conventional formulation of the drug, aiming to maximize antitumor efficacy while minimizing treatment-related toxicities. Results from the NAPOLI-1 study (NCT01494506) demonstrated the survival benefit of nal-IRI plus 5-FU/LV following disease progression with gemcitabine-based therapy in patients with mPDAC.

The combination therapy of nal-IRI + 5-FU/LV significantly increased the median overall survival (OS: 6.1 months, 95% confidence interval [CI]: 4.8-8.9) and progression-free survival (PFS) (3.1 months, 95% CI: 2.7-4.2) as compared with 5-FU/LV alone (OS: 4.2 months, 95% CI: 3.3-5.3; PFS: 1.5 months, 95% CI: 1.4-1.8). It was confirmed in an updated analysis published in 2019.

Moreover, in a phase 1/2 trial (NCT02551991), liposomal irinotecan, in combination with fluorouracil, leucovorin, and oxaliplatin (NALIRIFOX), demonstrated promising antitumor activity in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma.

The NALIRIFOX regimen, comprising nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin, has emerged as a promising alternative to traditional FOLFIRINOX.

Considering the efficacy of FOLFIRINOX and the improved properties of nanoliposomal irinotecan, the NALIRIFOX regimen holds the potential to provide a more potent and well-tolerated first-line treatment option.

The results of the Phase 3 Study NAPOLI 3 were very prominent. The rationale of the NAPOLI 3 study was to evaluate the efficacy and safety of the NALIRIFOX regimen in patients metastatic pancreatic cancer who have not received prior treatment for metastatic disease, aiming to improve survival outcomes and quality of life for this patient population.

Median overall survival was 11·1 months (95% CI 10·0-12·1) with NALIRIFOX versus 9·2 months (8·3-10·6) with nab-paclitaxel-gemcitabine (hazard ratio 0·83; 95% CI 0·70-0·99; p=0·036). Grade 3 or higher treatment-emergent adverse events occurred in 322 (87%) of 370 patients receiving NALIRIFOX and 326 (86%) of 379 patients receiving nab-paclitaxel-gemcitabine; treatment-related deaths occurred in six (2%) patients in the NALIRIFOX group and eight (2%) patients in the nabpaclitaxel-gemcitabine group.

The data from the clinical trial NAPOLI 3 justify using the combination of NalIriFOx as a first-line therapy in mPDAC. Although randomized controlled trials (RCTs) are crucial in assessing drug efficacy and safety, the generated data are often different from those obtained in daily clinical practice.

By leveraging real-world data, this study aims to provide comprehensive insights into the regimen's clinical performance, patient outcomes, and tolerability in routine clinical practice, thereby informing and optimizing treatment strategies for this challenging disease.

Real-world data (RWD) and real-world evidence (RWE) play a crucial role in understanding the performance of new therapies in diverse patient populations outside the controlled environment of clinical trials. RWD can reveal variations in treatment responses, identify rare adverse events, and offer insights into patient quality of life and healthcare resource utilization.

This RWE study will thus contribute valuable information on the applicability and benefits of the NALIRIFOX regimen in a real-world setting, aligning clinical efficacy with practical utility.

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).

NaLIriFOX falls within the current practice as first-line treatment in patients with metastatic ductal adenocarcinoma. No additional diagnostic or monitoring procedures will be applied to the patients participating in this study.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Grækenland
      • Athens, Grækenland, 151 23
        • Rekruttering
        • Hygeia Hospital
        • Kontakt:
      • Athens, Grækenland, 124 62
        • Rekruttering
        • Attikon University General Hospital
        • Kontakt:
      • Athens, Grækenland, 145 64
        • Rekruttering
        • General Oncology Hospital Agioi Anargyroi
        • Kontakt:
      • Athens, Grækenland, 185 47
        • Rekruttering
        • 2nd Oncology Department, Metropolitan Hospital
        • Kontakt:
          • George Oikonomopoulos
          • Telefonnummer: +30 21 0480 9000
          • E-mail: goik77@yahoo.com
      • Athens, Grækenland
      • Larissa, Grækenland
        • Rekruttering
        • Larissa University General Hospital
        • Kontakt:
      • Pátrai, Grækenland, 263 32
        • Rekruttering
        • General Hospital Agios Andreas
        • Kontakt:
      • Thessaloniki, Grækenland, 570 10
        • Rekruttering
        • Thessaloniki General Hospital "George Papanikolaou"
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with mPDAC receiving NalIriFOx as first line therapy

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
mPDAC patients
mPDAC patients receiving NalIriFox as a first line therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Real World Data collection
Tidsramme: Time from study entry untill completion (12 months)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 12 months]
PFS of mPDAC patients after first line treatment with NalIriFOx
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)
Tidsramme: Time from study entry to death from any cause, assessed up to 12 months
To investigate the long-term prognostic significance of mPDAC patients receiving NalIriFOx as first line therapy, in terms of OS
Time from study entry to death from any cause, assessed up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hellenic Cooperative Oncology Group

Efterforskere

  • Ledende efterforsker: Athina Christopoulou, MD, PhD, Oncology Unit, General Hospital of Patras "Agios Andreas"
  • Ledende efterforsker: George Papaxoinis, MD, 2nd Dept of Medical Oncology, "Agios Savvas" Anti Cancer Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2026

Primær færdiggørelse (Anslået)

30. marts 2029

Studieafslutning (Anslået)

30. marts 2029

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HE3/24

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

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