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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)

2026년 7월 23일 업데이트: 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).

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

70

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 그리스
      • Athens, 그리스, 151 23
        • 모병
        • Hygeia Hospital
        • 연락하다:
      • Athens, 그리스, 124 62
        • 모병
        • Attikon University General Hospital
        • 연락하다:
      • Athens, 그리스, 145 64
        • 모병
        • General Oncology Hospital Agioi Anargyroi
        • 연락하다:
      • Athens, 그리스, 185 47
        • 모병
        • 2nd Oncology Department, Metropolitan Hospital
        • 연락하다:
          • George Oikonomopoulos
          • 전화번호: +30 21 0480 9000
          • 이메일: goik77@yahoo.com
      • Athens, 그리스
      • Larissa, 그리스
        • 모병
        • Larissa University General Hospital
        • 연락하다:
      • Pátrai, 그리스, 263 32
        • 모병
        • General Hospital Agios Andreas
        • 연락하다:
      • Thessaloniki, 그리스, 570 10
        • 모병
        • Thessaloniki General Hospital "George Papanikolaou"
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Patients with mPDAC receiving NalIriFOx as first line therapy

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
mPDAC patients
mPDAC patients receiving NalIriFox as a first line therapy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Real World Data collection
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hellenic Cooperative Oncology Group

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 30일

기본 완료 (추정된)

2029년 3월 30일

연구 완료 (추정된)

2029년 3월 30일

연구 등록 날짜

최초 제출

2026년 7월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 20일

처음 게시됨 (실제)

2026년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 23일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • HE3/24

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in South Korea

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다