The MATTERS Trial: Safety and Tolerability of Whole-Body Hyperthermia at 41.50°C in Combination with Chemotherapy in Metastatic Cancer Patients.

ABSTRACT:

Purpose

Whole-body hyperthermia (WBHT) is a promising therapy for advanced malignancies, including metastatic pancreatic ductal adenocarcinoma (PDAC). This first-in-human study evaluated the safety and tolerability of repeated WBHT sessions at 41.50°C for various treatment durations and in combination with standard-of-care chemotherapy regimens.

Patients and methods

Twelve patients with advanced solid tumors, primarily metastatic PDAC, completed the study. WBHT was administered using an innovative medical device (TempoCure, ElmediX) as monotherapy or with standard-of-care chemotherapy in escalating durations of 2, 4, and 6 hours, in four cohorts. Safety was assessed through adverse event (AE) monitoring, serious AE (SAE) reporting, and comprehensive clinical and laboratory e

SUBMITTER: Brancato L 

PROVIDER: S-EPMC12869149 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature