NCT04467593

Safety Study of Whole Body Hyperthermia for Advanced Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: ElmediX · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
DEVICE	Whole body hyperthermia	Whole body hyperthermia to treat stage IV cancer patients
DRUG	Standard of Care (SOC) chemotherapy according to the NCCN guidelines.	Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy

Timeline

• Start date: 2021-07-28
• Primary completion: 2024-12-25
• Completion: 2024-12-25
• First posted: 2020-07-13
• Last updated: 2025-08-05

Locations

1 site across 1 country: Belgium