Hellenic Evaluation of the Long-Term Safety and Efficacy of NalIriFOx as a 1st-line Therapy in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (HELIOS)
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Ioanna Mitrentsi, PhD
- Telefonnummer: 24 +30 2106912520
- E-Mail: i_mitrentsi@hecog.ondsl.gr
Studieren Sie die Kontaktsicherung
- Name: Maria Moschoni
- Telefonnummer: 12 +30 2106912520
- E-Mail: m_moschoni@hecog.ondsl.gr
Studienorte
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Athens, Griechenland, 151 23
- Rekrutierung
- Hygeia Hospital
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Kontakt:
- alexios Strimpakos
- Telefonnummer: +30 21 0686 7000
- E-Mail: astrimpakos@hygeia.gr
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Athens, Griechenland, 124 62
- Rekrutierung
- Attikon University General Hospital
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Kontakt:
- kotsantis
- Telefonnummer: +30 21 0583 1000
- E-Mail: ikotsantis@gmail.com
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Athens, Griechenland, 145 64
- Rekrutierung
- General Oncology Hospital Agioi Anargyroi
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Kontakt:
- Fotis Tzoudas
- Telefonnummer: +30 21 0350 1500
- E-Mail: fotis_tzoudas@hotmail.com
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Athens, Griechenland, 185 47
- Rekrutierung
- 2nd Oncology Department, Metropolitan Hospital
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Kontakt:
- George Oikonomopoulos
- Telefonnummer: +30 21 0480 9000
- E-Mail: goik77@yahoo.com
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Athens, Griechenland
- Rekrutierung
- Ippokratio
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Kontakt:
- Gkotzamanidou
- Telefonnummer: +30 2132089511
- E-Mail: mgkotzamanidou@yahoo.com
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Larissa, Griechenland
- Rekrutierung
- Larissa University General Hospital
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Kontakt:
- Kotsakis
- Telefonnummer: +30 2413502124
- E-Mail: thankotsakis@hotmail.com
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Pátrai, Griechenland, 263 32
- Rekrutierung
- General Hospital Agios Andreas
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Kontakt:
- Athina Christopoulou
- Telefonnummer: +30 261 360 1000
- E-Mail: athinachristo@hotmail.com
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Thessaloniki, Griechenland, 570 10
- Rekrutierung
- Thessaloniki General Hospital "George Papanikolaou"
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Kontakt:
- Elena Fountzilas
- Telefonnummer: +30 231 330 7000
- E-Mail: elenafou@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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mPDAC patients
mPDAC patients receiving NalIriFox as a first line therapy
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Real World Data collection
Zeitfenster: Time from study entry untill completion (12 months)
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Record clinical practice and collect real-world data (RWD) on the clinical efficacy and safety of NalIriFOx as a first-line therapy in mPDAC
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Time from study entry untill completion (12 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Progression Free Survival (PFS)
Zeitfenster: Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 12 months]
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PFS of mPDAC patients after first line treatment with NalIriFOx
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Time from study entry to first recurrence (local, regional, distant) or death from any cause, whichever comes first, assessed up to 12 months]
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Overall Survival (OS)
Zeitfenster: Time from study entry to death from any cause, assessed up to 12 months
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To investigate the long-term prognostic significance of mPDAC patients receiving NalIriFOx as first line therapy, in terms of OS
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Time from study entry to death from any cause, assessed up to 12 months
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Athina Christopoulou, MD, PhD, Oncology Unit, General Hospital of Patras "Agios Andreas"
- Hauptermittler: George Papaxoinis, MD, 2nd Dept of Medical Oncology, "Agios Savvas" Anti Cancer Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- HE3/24
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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