NCT06022692: HEAIS001

Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours

Completed Phase 1, PHASE2 Last updated 5 September 2023

What this trial tests

Phase 1, PHASE2 trial testing Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany) in Gastrointestinal Tumor in 18 participants. Completed in 1 August 2023.

Timeline

1 June 2020

Primary endpoint
31 May 2022

1 August 2023

Quick facts

Lead sponsor	Pengyuan Liu
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 June 2020
Primary completion	31 May 2022
Estimated completion	1 August 2023
Sites	1 location across China

Drugs / interventions tested

• Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany)
• tislelizumab (BeiGene, China) combined with PD-1 inhibitor — full drug profile →

Conditions studied

• Gastrointestinal Tumor — all drugs for Gastrointestinal Tumor →

Sponsor

Pengyuan Liu — full company profile →

Who can join

Adults 18 to 75, any sex, with Gastrointestinal Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastrointestinal tumours (GITs) are the most common and fatal cancers worldwide; 96% of GITs show the microsatellite-stable (MSS)/proficient mismatch repair (pMMR) phenotype, and these tumours have a poor response to immune checkpoint inhibitor (ICI) therapy. Hyperthermia combined with ICI treatment (HIT) has been reported to show a synergistic sensitisation effect in numerous basic studies. This study aimed to validate the effectiveness, safety, and feasibility of water-filtered infrared A radiation (WIRA) whole-body hyperthermia combined with PD-1 inhibitor therapy and evaluate the real-world clinical application prospects of HIT. This open-label single-arm phase 2 clinical trial aimed to enrol advanced GIT patients with the MSS/pMMR phenotype in the East Asian population who had received third-line or higher treatment. The patients were treated with whole-body hyperthermia on days 1 and 8 of each HIT cycle along with administration of tislelizumab 200 mg on day 2 (24 h after the hyperthermia at day 1). The primary outcome was the disease control rate (DCR), while the secondary outcomes were progression-free survival (PFS), overall survival (OS), safety, and improvement in quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Water-filtered infrared A radiation hyperthermia combined with immunotherapy for advanced gastrointestinal tumours.
   Liu P, Wu J, Chen L, Wu Z, et al · · 2024 · cited 5× · PMID 39049187 · DOI 10.1002/cam4.70024