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

Starting soon · Phase 2/Phase 3

Conditions studied: Pancreatic Ductal Adenocarcinoma (mPDAC), Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

In brief

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.

Key facts

Study ID: NCT07711067
Run by: ElmediX
People needed: 95
Starts: 2026-10-01
Expected to finish: 2030-12-31
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

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
Implants that are not compatible with temperature changes
(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
Other clinically significant disease which could impair the subject's ability to participate in the study according to the investigator's opinion
Participation in another clinical trial 2 weeks prior to the randomization
Biological therapy during the 2 weeks prior to the randomization
Radiotherapy up to 2 weeks prior to the randomization
Major surgery up to 6 weeks prior to the randomization (port-a-cath placement is minor)

Where it is running

Universitair Ziekenhuis Antwerpen (UZA) — Antwerp, Antwerpen, Belgium
Algemeen Ziekenhuis Maria Middelares (AZ MM) — Ghent, Oost-Vlaanderen, Belgium
Hospital Universitario HM Sanchinarro (HM CIOCC) — Madrid, Madrid, Spain
Clinica Universidad de Navarra — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.