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

NCT07711067 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CIV-26-06-058215
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC); Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

Hyperthermia; Medical device

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  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

  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

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Up to time of progression, death or study discontinuation; an (expected) average of 8 months

• Disease control rate (DCR)

  Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

• Objective response rate (ORR)

  Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

• Quality of Life assessments (EORTC-QLQ-C30 version 3)

  Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

• Quality of Life assessments (QLQ Pan 26)

  Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

Other Outcomes (1)

• Exploratory analyses

  Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Participants receive standard-of-care systemic treatment as indicated for metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of the first-line treatment.

Drug: Standard-of-Care Systemic therapy

Whole-body hyperthermia treatment (WBHT) group

EXPERIMENTAL

Participants will receive whole-body hyperthermia (WBHT) alongside their indicated standard-of-care systemic treatment.

Device: Whole-body hyperthermia; Drug: Standard-of-Care Systemic therapy

Interventions

Standard-of-Care Systemic therapy DRUG

Standard-of-care systemic therapy for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of first-line treatment.

Control group; Whole-body hyperthermia treatment (WBHT) group

Whole-body hyperthermia DEVICE

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.

Also known as: WBHT, WBH, Systemic hyperthermia, Whole-body thermal treatment, WBTT

Whole-body hyperthermia treatment (WBHT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects at least 18 years of age at time of signing the informed consent
• Subjects with metastatic pancreatic adenocarcinoma (PDAC) confirmed by histology
• Measurable disease per RECIST 1.1
• Subjects previously treated with chemotherapy in first line for metastatic disease
• ECOG performance status ≤ 1
• Height ≤ 2,00 m, BMI maximal 40 or positive fitting session
• 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)
• Adequate bone marrow function defined as
• white blood cell count ≥ 2000/µl
• neutrophils ≥ 1500 cells/μL
• platelets ≥ 100 x 109/L
• hemoglobin ≥ 9 g/dl (female) and ≥10 g/dl (male) documented
• Adequate coagulation defined as
• PT (%) ≥ 70%
• aPTT ≤ ULN

You may not qualify if:

• Pregnant or breastfeeding women
• Presence of brain metastasis (known or suspected)
• 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)
• 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.
• Pathology that would interfere with the placement of the bladder catheter
• Clinically significant pulmonary disease which might interfere with mechanical ventilation
• History of autonomic dysfunction (due to the influence on skin blood flow)
• History of malignant hyperthermia
• History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).
• Primary untreated diabetes type I not related to the oncological condition (due to vascular complications).
• Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, chemotherapy)
• Active infections not controlled by medication
• Presence of clinically significant ascites and/or decompensated cirrhosis/portal hypertension
• Severe, non-healing wounds, ulcers or bone fractures
• Organ allografts requiring immunosuppressive therapy

Sponsors & Collaborators

• ElmediX: lead
• Xper research: collaborator

Study Sites (4)

Universitair Ziekenhuis Antwerpen (UZA)

Antwerp, Antwerpen, 2650, Belgium

Location

Algemeen Ziekenhuis Maria Middelares (AZ MM)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Hospital Universitario HM Sanchinarro (HM CIOCC)

Madrid, Madrid, 28050, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

John-Paul Bogers, Prof. Dr.

CONTACT

+32 474296669; john-paul.bogers@elmedix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to one of two groups: A control group with standard-of-care systemic therapy or a treatment group where WBHT is added to this standard-of-care.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); BE (2)