Clinical trialNACompleted
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
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 28 July 2021
- Expected end
- 25 December 2024
- Enrollment
- 16 participants
- Sites
- 1
- Primary outcomes
- Safety of WBHT at 41.50 °C in Combination With Chemotherapy; Tolerability of WBHT at 41.50 °C in Combination With Chemotherapy
- Sponsor
- Industry
- Results posted
- 2026-10-23
- Last update
- 23 October 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Safety of WBHT at 41.50 °C in Combination With Chemotherapy [Up to 4 weeks after last treatment (last treatment administered up to 40 days from baseline)]. Number, Number of adverse events. Total AE and SAE related or unrelated to the treatment: Cohort A1 (n=4): 55; Cohort A2 (n=1): 20; Cohort B (n=4): 62; Cohort C (n=3): 49. Total AE and SAE related to the treatment: Cohort A1 (n=4): 39; Cohort A2 (n=1): 17; Cohort B (n=4): 35; Cohort C (n=3): 37. Total SAE related or unrelated to treatment: Cohort A1 (n=4): 9; Cohort A2 (n=1): 4; Cohort B (n=4): 3; Cohort C (n=3): 4. Total SAE related to treatment: Cohort A1 (n=4): 5; Cohort A2 (n=1): 2; Cohort B (n=4): 1; Cohort C (n=3): 1.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tolerability of WBHT at 41.50 °C in Combination With Chemotherapy [Up to 4 weeks after last treatment (last treatment administered up to 40 days from baseline)]. Count Of Participants, Participants. Patients that completed all intended treatments: Cohort A1 (n=4): 2; Cohort A2 (n=1): 1; Cohort B (n=4): 3; Cohort C (n=3): 3. Patients that did not complete all intended treatments: Cohort A1 (n=4): 2; Cohort A2 (n=1): 0; Cohort B (n=4): 1; Cohort C (n=3): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Measured Percent Change in Serum Marker CA19-9 in Response to Thermal Treatment [1 day after the first hyperthermia treatment (2 days from baseline)]. Mean, Percentage change (Standard Deviation). Cohort A1 (n=1): -17.5 (0); Cohort B (n=3): -17.3 (8.4); Cohort C (n=3): -1.0 (21.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Feasibility of Whole-body Thermal Treatment Delivery. [Up to 4 weeks after last treatment (last treatment administered up to 40 days from baseline)]. Number, Number of dose-limiting toxicities. Cohort A1 (n=4): 0; Cohort A2 (n=1): 0; Cohort B (n=4): 0; Cohort C (n=3): 0.