NCT04617457

Brief Summary

This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial. Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Oct 2021

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

3.2 years

First QC Date

October 29, 2020

Last Update Submit

January 9, 2024

Conditions

Pancreatic CancerMetastasisSurgeryOligometastatic Disease

Keywords

pancreatic cancerNAPOXchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival after R0/R1 resection (OS-res)

    OS for patient after macroscopic tumor resection

    max 24 months follow-up

Secondary Outcomes (7)

  • R0/R1 resection rate after neoadjuvant chemotherapy

    direct after operation

  • Overall survival (OS)

    max 24 months follow-up

  • Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1

    max 24 months follow-up

  • Type, frequency and severity of adverse events (AE) with severity (SAE) according to NCI CTCAE version 5.0

    direct after IMP administration up to 3 months after completion of study

  • HR-QoL according to EORTC QLQ-C30

    90 days after operation

  • +2 more secondary outcomes

Study Arms (1)

NAPOX chemotherapy

EXPERIMENTAL

NAPOX chemotherapy in 14-day cycles with the four IMPs given intravenously in the following order: nal-irinotecan, oxaliplatin, folinic acid and 5-fluouracil.

Drug: nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)

Interventions

nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)DRUG

preoperative chemotherapy

Also known as: nal-irinotecan (nal-iri), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA), ONIVYDE TM
NAPOX chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Measurable disease according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate renal, hepatic and bone marrow function, defined as
  • Calculated creatinine clearance ≥60 mL/min
  • Total bilirubin ≤2 mg/dL; patients with biliary stent may be included if bilirubin level decreased to ≤2 mg/dL after stent insertion
  • alanin-aminotransferase and aspartat-aminotransferase (ALT and AST) ≤5 × upper limit of normal (ULN)
  • Absolute neutrophil count (ANC) ≥1.5 × 109/L
  • Thrombocytes ≥100 × 109/L
  • Haemoglobin ≥9 g/dL
  • activated partial thromboplastin time (aPTT) ≤1.5 × ULN and Quick value ≥70%
  • Patients ≥18 years at the time of signing the informed consent
  • Females of childbearing potential (FCBPs) must agree to use highly effective contraceptive measures (Pearl index \<1) or practice true abstinence from any heterosexual intercourse for the duration of treatment and for at least 1 month after the last IMP administration (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient). A woman will be considered as being of childbearing potential unless she is at least 50 years old and, moreover, has gone through menopause for at least 2 years or has been surgically sterilised.
  • Males must agree to use condoms or practice true abstinence from any heterosexual intercourse for the duration of IMP treatment and at least 6 months after the last IMP administration (true abstinence is acceptable if this is in line with the patient's preferred and usual lifestyle). Male patients must furthermore refrain from donating sperm during the clinical trial until at least 6 months after the last IMP administration.
  • Patient's written informed consent prior to any trial-specific procedure
  • Patient's legal capacity to consent to participation in the clinical trial

You may not qualify if:

  • Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
  • Symptomatic clinically significant ascites
  • Any tumour-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures)
  • Any malignancies other than adenocarcinoma of the pancreas in the 5 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumours (Ta, Tis and T1)
  • Hypersensitivity to any of the IMPs or any of the excipients
  • Any major surgery within 4 weeks before the first IMP administration
  • Pregnant or breast-feeding female
  • Known chronic inflammatory bowel disease, bowel obstruction or chronic diarrhoea Grade ≥2 according to NCI CTCAE version 5.0
  • Peripheral polyneuropathy Grade ≥2 according to NCI CTCAE version 5.0
  • Known interstitial lung disease (ILD) or pulmonary fibrosis
  • Radiographic evidence of severe portal hypertension
  • Liver cirrhosis ≥ Child Pugh B
  • Cholestasis or cholangitis despite adequate biliary stenting; treatment with anti-infectious agents is permitted; patient must be disease-free and without anti-infectious treatment for 7 days before the first IMP administration
  • Active infection requiring systemic therapy
  • Known HIV seropositivity
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University Aachen

Aachen, Germany

RECRUITING

University of Berlin, Charité, Campus Benjamin-Franklin

Berlin, Germany

ACTIVE NOT RECRUITING

University of Bonn

Bonn, Germany

ACTIVE NOT RECRUITING

Städtisches Klinikum Dresden

Dresden, Germany

RECRUITING

University of Düsseldorf

Düsseldorf, Germany

ACTIVE NOT RECRUITING

University of Freiburg

Freiburg im Breisgau, Germany

RECRUITING

University of Halle (Saale)

Halle, Germany

RECRUITING

University of Heidelberg

Heidelberg, Germany

RECRUITING

Klinikum Großhadern, LMU München

München, Germany

ACTIVE NOT RECRUITING

Klinikum Rechts der Isar Technische Universität München

München, Germany

RECRUITING

University of Regensburg

Regensburg, Germany

RECRUITING

Related Publications (1)

  • Gebauer F, Damanakis AI, Popp F, Quaas A, Kutting F, Lutz K, Held S, Deuss B, Goser T, Waldschmidt D, Bruns C. Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC). BMC Cancer. 2021 Nov 18;21(1):1239. doi: 10.1186/s12885-021-08966-3.

    PMID: 34794396BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasm Metastasis

Interventions

irinotecan sucrosofateOxaliplatinFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Florian Gebauer, MD

    University of Witten/Herdecke

    PRINCIPAL INVESTIGATOR

  • Dirk Waldschmidt

    University of Cologne

    STUDY DIRECTOR

Central Study Contacts

Florian Gebauer, MD

CONTACT

+492028961563florian.gebauer@helios-gesundheit.de

Dirk Waldschmidt, MD

CONTACT

dirk.waldschmidt@uk-koeln.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 5, 2020

Study Start

October 10, 2021

Primary Completion

December 31, 2024

Study Completion

September 30, 2025

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(11)