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

14. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

95

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

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

Beskrivelse

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)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: 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.
Eksperimentel: Whole-body hyperthermia treatment (WBHT) group
Participants will receive whole-body hyperthermia (WBHT) alongside their indicated standard-of-care systemic treatment.
Medicin: 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.
Enhed: 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.
Andre navne:
  • WBH
  • WBHT
  • Systemic hyperthermia
  • Whole-body thermal treatment
  • WBTT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory analyses
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

ElmediX

Samarbejdspartnere

Xper research

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 (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. marts 2030

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIV-26-06-058215

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Pancreas Ductal Adenocarcinom (mPDAC)

Kliniske forsøg med Standard-of-Care Systemic therapy

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