Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer (MATTERS-2)

14 juli 2026 bijgewerkt door: ElmediX

A Multi-Centric, Randomized, Pivotal Study, Evaluating Efficacy and Safety of Whole-Body Hyperthermia Alongside Standard Systemic Anticancer Therapy in Patients With Metastatic Pancreatic Cancer After Failure of First Line Treatment.

Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy. Whole-body hyperthermia (WBHT) is a non-invasive treatment approach that raises the body's core temperature under controlled conditions and may enhance the effects of anticancer therapies through multiple biological mechanisms, including improved drug delivery, modulation of the immune response, and increased sensitivity to treatment.

The MATTERS-2 study is a multicentre, randomized clinical trial designed to evaluate the efficacy and safety of WBHT in combination with standard systemic anticancer therapy in patients with metastatic PDAC after failure of first-line treatment. Participants will receive either standard systemic therapy alone or standard systemic therapy combined with WBHT.

The primary objective of the study is to determine whether the addition of WBHT improves clinical outcomes compared with standard therapy alone in terms of overall survival (OS) while maintaining safety. Secondary objectives include other clinical outcomes such as progression-free survival (PFS), disease control rate (DCR) and objective response rate (ORR). Further, quality of life assessments (QoL) and exploratory biomarker analyses will also be performed.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

95

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • België
    • Antwerpen
      • Antwerp, Antwerpen, België, 2650
        • Universitair Ziekenhuis Antwerpen (UZA)
        • Hoofdonderzoeker:
          • Timon Vandamme, Prof. Dr.
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, België, 9000
        • Algemeen Ziekenhuis Maria Middelares (AZ MM)
        • Hoofdonderzoeker:
          • Vincent Bouderez, Dr.
  • Spanje
    • Madrid
      • Madrid, Madrid, Spanje, 28050
        • Hospital Universitario HM Sanchinarro (HM CIOCC)
        • Hoofdonderzoeker:
          • Antonio Cubillo, Dr.
    • Navarre
      • Pamplona, Navarre, Spanje, 31008
        • Clinica Universidad de Navarra
        • Hoofdonderzoeker:
          • Mariano Ponz, Dr.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Subjects at least 18 years of age at time of signing the informed consent
  2. Subjects with metastatic pancreatic adenocarcinoma (PDAC) confirmed by histology
  3. Measurable disease per RECIST 1.1
  4. Subjects previously treated with chemotherapy in first line for metastatic disease
  5. ECOG performance status ≤ 1
  6. Height ≤ 2,00 m, BMI maximal 40 or positive fitting session
  7. Adequate liver structure (accessible metastasis-free and functional liver parenchyma) allowing stable liver sensor positioning without unacceptable risks of bleeding and perforation, based on echographic assessment (or any imaging modality)

  8. Adequate bone marrow function defined as

    1. white blood cell count ≥ 2000/µl
    2. neutrophils ≥ 1500 cells/μL
    3. platelets ≥ 100 x 109/L
    4. hemoglobin ≥ 9 g/dl (female) and ≥10 g/dl (male) documented

  9. Adequate coagulation defined as

    1. PT (%) ≥ 70%
    2. aPTT ≤ ULN

  10. Adequate liver function defined as

    1. Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis
    2. bilirubin ≤ 2 x ULN
  11. Adequate renal function defined as calculated eGFR ≥ 60 mL/min (CKD-EPI equation)
  12. Normal ionogram
  13. Effective contraception for both male and female subjects if applicable. Women of childbearing potential must have a negative pregnancy test at screening visit.
  14. Written informed consent must be given according to good clinical practice and national/local regulations.

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. Presence of brain metastasis (known or suspected)
  3. Other malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin)
  4. Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk defined as recent major cardiovascular events (such as myocardial infarction or stroke), clinically relevant heart failure due to structural or mechanical cardiac abnormalities (e.g., valvular disease or myocardial dysfunction), and clinically significant arrhythmias.
  5. Pathology that would interfere with the placement of the bladder catheter
  6. Clinically significant pulmonary disease which might interfere with mechanical ventilation
  7. History of autonomic dysfunction (due to the influence on skin blood flow)
  8. History of malignant hyperthermia
  9. History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).
  10. Primary untreated diabetes type I not related to the oncological condition (due to vascular complications).
  11. Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, chemotherapy)
  12. Active infections not controlled by medication
  13. Presence of clinically significant ascites and/or decompensated cirrhosis/portal hypertension
  14. Severe, non-healing wounds, ulcers or bone fractures
  15. Organ allografts requiring immunosuppressive therapy
  16. Implants that are not compatible with temperature changes
  17. (History of) clinically significant (investigator decision) psychiatric disorder and/or psychosocial disorder that may interfere with adequate compliance to the protocol or signature of the informed consent
  18. Other clinically significant disease which could impair the subject's ability to participate in the study according to the investigator's opinion
  19. Participation in another clinical trial 2 weeks prior to the randomization
  20. Biological therapy during the 2 weeks prior to the randomization
  21. Radiotherapy up to 2 weeks prior to the randomization
  22. Major surgery up to 6 weeks prior to the randomization (port-a-cath placement is minor)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Control group
Participants receive standard-of-care systemic treatment as indicated for metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of the first-line treatment.
Geneesmiddel: Standard-of-Care Systemic therapy
Standard-of-care systemic therapy for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of first-line treatment.
Experimenteel: Whole-body hyperthermia treatment (WBHT) group
Participants will receive whole-body hyperthermia (WBHT) alongside their indicated standard-of-care systemic treatment.
Geneesmiddel: Standard-of-Care Systemic therapy
Standard-of-care systemic therapy for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of first-line treatment.
Apparaat: Whole-body hyperthermia
Initially every 2 weeks, until a total of 3 treatments is reached. Thereafter every 4 weeks. The treatment will raise the body temperature to 41,50 °C for a total of 4 hours.
Andere namen:
  • WBH
  • WBHT
  • Systemic hyperthermia
  • Whole-body thermal treatment
  • WBTT

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall survival (OS)
Tijdsspanne: From randomization until death from any cause, assessed up to study completion (primary analysis triggered upon occurrence of 66 death events), an (expected) average of 12 months
To compare Overall Survival (OS) between WBHT + standard-of-care (SoC) and SoC treatment group
From randomization until death from any cause, assessed up to study completion (primary analysis triggered upon occurrence of 66 death events), an (expected) average of 12 months
Safety and tolerability of WBHT + SoC and SoC alone
Tijdsspanne: From moment of enrollment (ICF signature) up to End of Treatment visit, an (expected) average of 10 months
Incidence of Adverse Events (AE), Serious Adverse Events (SAE), treatment-related AE/SAE and Adverse Device Effects (ADE). They will be reported from moment of enrollment (ICF signature) up to End of Treatment visit and will be assessed for seriousness, severity and relationship to the device and to WBHT treatment.
From moment of enrollment (ICF signature) up to End of Treatment visit, an (expected) average of 10 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free survival (PFS)
Tijdsspanne: Up to time of progression, death or study discontinuation; an (expected) average of 8 months
To compare Progression-Free Survival (PFS) between WBHT +SoC and SoC treatment group based on RECIST 1.1. criteria.
Up to time of progression, death or study discontinuation; an (expected) average of 8 months
Disease control rate (DCR)
Tijdsspanne: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
To compare Disease Control Rate (DCR) between WBHT +SoC and SoC treatment group based on RECIST 1.1 criteria.
Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
Objective response rate (ORR)
Tijdsspanne: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
To compare Objective Response Rate (ORR) between WBHT +SoC and SoC treatment group based on RECIST 1.1 criteria and further described with duration of response (DOR) and time to response (TTR).
Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
Quality of Life assessments (EORTC-QLQ-C30 version 3)
Tijdsspanne: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
Quality of Life (QoL) according to EORTC-QLQ-C30 version 3 scoring changes from baseline (at 4-weeks, 8-weeks and End of Treatment)
Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
Quality of Life assessments (QLQ Pan 26)
Tijdsspanne: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
Quality of Life (QoL) according to QLQ Pan 26 scoring changes from baseline (at 4-weeks, 8-weeks and End of Treatment)
Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
Evolution of CA19-9
Tijdsspanne: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
To evaluate CA19-9 changes from baseline in WBHT +SoC and SoC treatment groups (at 4-weeks, 8-weeks and End of Treatment)
Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exploratory analyses
Tijdsspanne: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months
To explore potential biomarkers and molecular correlates through the analysis of blood and tumor tissue samples.
Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

ElmediX

Medewerkers

Xper research

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

31 maart 2030

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

29 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juli 2026

Eerst geplaatst (Werkelijk)

17 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CIV-26-06-058215

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren