Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

14 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

95

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Droga: 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.
Sperimentale: Whole-body hyperthermia treatment (WBHT) group
Participants will receive whole-body hyperthermia (WBHT) alongside their indicated standard-of-care systemic treatment.
Droga: 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.
Dispositivo: 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.
Altri nomi:
  • WBH
  • WBHT
  • Systemic hyperthermia
  • Whole-body thermal treatment
  • WBTT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Exploratory analyses
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ElmediX

Collaboratori

Xper research

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

31 marzo 2030

Completamento dello studio (Stimato)

31 dicembre 2030

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CIV-26-06-058215

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Standard-of-Care Systemic therapy

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Switzerland

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi