Advanced CancerMATTERSNCT04467593
Safety Study of Whole Body Hyperthermia for Advanced Cancer
A study testing Whole body hyperthermia in people with Advanced Cancer and Pancreatic Cancer Metastatic, run by ElmediX at 1 site in Belgium.
Trial summary
Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer, Pancreatic Cancer Metastatic
- What is being tested?
- Whole body hyperthermia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jul 2021to 25 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18- and 75-years of age at time of signing the informed consent
- Patients with advanced solid cancer (for cohort A1, A2 only) or metastatic pancreatic adenocarcinoma confirmed by histology (for cohort B/C/D only)
- Patients previously treated or under treatment with standard of care treatment (cohort B/C/D only) or patients without treatment options
- WHO performance status ≤ 1(see appendix V)
- Maximum waist circumference ≤ 150 cm
- Weight ≤ 100 kg
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- Height ≤ 1,90 m
- Adequate liver structure (confirmed by CT scan) allowing the placement of the liver sensor
- No (prostate) pathology that would interfere with the placement of the bladder catheter
- Adequate bone marrow function defined as
- white blood cell count ≥ 2000/µl
- neutrophils ≥ 1500 cells/μL
- platelets ≥ 100 x 109/L
- hemoglobin ≥ 10 g/dl documented within 1 week prior to first treatment
- Adequate coagulation defined as
- PT (%) ≥ 70%
- aPTT ≤ ULN
- Von Willebrand Factor Antigen ≥ LLN
- Von Willebrand Factor Activity ≥ LLN
- PFA COL/EPI CT ≤ 1.15 ULN
- PFA COL/ADP CT ≤ 1.15 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 documented
- Adequate renal function defined as
- serum creatinine ≤ 1.6 mg/dL (male); ≤ 1.3 mg/dL (female);
- albumin ≥ 30g/L
- calculated eGFR ≥ 60 mL/min (CKD-EPI equation) documented within 1 week prior to randomization
- No blood donation 3 months prior to the WBHT treatment
- No participation in other clinical trial 4 weeks prior to the WBHT treatment
- No biological therapy 4 weeks prior to the WBHT treatment or during WBHT treatment
- No surgery 4 weeks prior to the WBHT treatment
- No radiotherapy 3 weeks prior to the WBHT treatment or during WBHT treatment
- No chemotherapy 1 week prior to the WBHT treatment (for cohort A/B/C/D) or during WBHT treatment (for Cohort A1/A2)
- No anti-platelet aggregation medication intake from 5 days prior to the first WBHT treatment until 5 days after the last treatment
- No anticoagulant medication intake between screening and last follow-up visit. However, if deemed necessary by the investigator, the patient may receive prophylactic Low Molecular Weight Heparin on the day prior to the first WBHT treatment until 10 days after the last WBHT treatment
- No transdermal patches during participation in the study
- No piercings (internally or externally)during WBHT treatment
- Life expectancy of at least 18 weeks
- Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
- Written informed consent must be given according to good clinical practice and national/local regulations.
Who cannot join
- Pregnant or breastfeeding women (based on HCG levels)
- 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, coronary stenting or myocardial infarction in the last year
- Clinically significant pulmonary disease which might interfere with mechanical ventilation
- History of autonomic dysfunction (due to the influence on skin blood flow)
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- History of malignant hyperthermia or a positive diagnostic test (Caffeine-Halothane Contracture test) in case of family history of malignant hyperthermia.
- History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).
- Primary diabetes type I (due to vascular complications)
- Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, (chemotherapy used in cohort B/C/D))
- Active infections not controlled by medication
- Severe, non-healing wounds, ulcers or bone fractures
- Organ allografts requiring immunosuppressive therapy
- (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 patient's ability to participate in the study according to the investigator's opinion
- Participation in another clinical trial during this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mono-centric, First In-human (FIH), Safety and Preliminary Efficacy Study of (Neo)Adjuvant, Model-based, Whole-body Hyperthermia (WBHT) Treatment in Advanced Solid Cancer Patients or Stage IV (TxNxM1) Metastatic Pancreatic Adenocarcinoma Patients
Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. The sponsor has developed a novel device to use hyperthermia for advanced cancer. This study is to prove the safety in human patients of this device \& therapy and get the first data on efficacy.
- Conditions
- Advanced Cancer, Pancreatic Cancer Metastatic
- Being tested
- Whole body hyperthermia, Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body hyperthermiaDevice
Whole body hyperthermia to treat stage IV cancer patients
Standard of Care (SOC) chemotherapy according to the NCCN guidelines.Drug
Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | Three patients with advanced solid cancer will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15) Receives: Device: Whole body hyperthermia |
| Cohort A2 | Experimental | One patient with advanced solid cancer will receive 3 hyperthermia treatments of 4 hours per treatment. The next patient with advanced solid cancer will receive 3 hyperthermia treatments of 6 hours per treatment. Receives: Device: Whole body hyperthermia |
| Cohort B | Experimental | Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines. Receives: Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines. |
| Cohort C | Experimental | Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines. Receives: Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines. |
| Cohort D | Experimental | Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines. Receives: Device: Whole body hyperthermia; Drug: Standard of Care (SOC) chemotherapy according to the NCCN guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of WBHT at 41.50 °C in Combination With Chemotherapy
Assessment of the safety of whole-body hyperthermia (WBHT) administered at 41.50 °C in combination with standard-of-care chemotherapy, based on the incidence and severity of adverse events.
Measured: Up to 4 weeks after last treatment (last treatment administered up to 40 days from baseline)
Tolerability of WBHT at 41.50 °C in Combination With Chemotherapy
Ability to complete all planned WBHT sessions within the protocol at the intended target temperature and duration without premature discontinuation of a treatment or withdrawal before completion of intended treatments.
Measured: Up to 4 weeks after last treatment (last treatment administered up to 40 days from baseline)
Secondary outcomes (2)
Measured Percent Change in Serum Marker CA19-9 in Response to Thermal Treatment
Evolution of clinically significant biological parameter will be measured after first treatment (only hyperthermia) compared to baseline. Percent change from baseline in serum CA19-9 was calculated for each participant as ((post-treatment CA19-9 - baseline CA19-9) / baseline CA19-9) × 100. The reported value represents the mean percent change across participants within each cohort.
Measured: 1 day after the first hyperthermia treatment (2 days from baseline)
Feasibility of Whole-body Thermal Treatment Delivery.
Feasibility of WBHT delivery assessed by dose-limiting toxicities.
Measured: Up to 4 weeks after last treatment (last treatment administered up to 40 days from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start28 Jul 2021
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElmediX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Peeters, MD PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467593
- Sponsor's protocol ID
- MATTERS 1
- Acronym
- MATTERS
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2020
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brancato L, Gorbaslieva I, Rudenko O, Logghe T, van Zwol E, Boulet G, Van den Bossche L, Van den Bossche J, Peeters M, Chapelle T, Saldien V, Vueghs P, Vandamme T, Dankerlui R, Ysebaert D, Bogers J. The MATTERS Trial: Safety and Tolerability of Whole-Body Hyperthermia at 41.50 degrees C in Combination with Chemotherapy in Metastatic Cancer Patients. Cancer Res Commun. 2026 Feb 1;6(2):273-283. doi: 10.1158/2767-9764.CRC-25-0660.
PubMed 41642747