Clinical trial · Interventional
Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours
Water-filtered Infrared A Radiation Whole-body Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours: A Prospective Open-label Single-arm Phase 2 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Tumor | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tislelizumab (BeiGene, China) combined with PD-1 inhibitor | Drug | — | UNRESOLVED |
| Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hyperthermia combined with immune checkpoint inhibitor group
- description
- 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).
- interventionNames
- Device: Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany)
- Drug: tislelizumab (BeiGene, China) combined with PD-1 inhibitor
Primary outcomes (1)
- measure
- disease control rate (DCR)
- timeFrame
- up to 6 months
- description
- DCR=(PR+CR) / (PD+SD+PR+CR) \* 100%
Secondary outcomes (2)
- measure
- progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced GIT who have previously received third-line or above treatment. * Patients are aged 18-75. * Patients with at least one measurable tumor lesion. * Patients' all physiological indexes meet the HIT requirements. Exclusion Criteria: * Patients have participated in other clinical trials within 4 weeks before enrollment. * Patients contraindicate to whole-body hyperthermia. * Patients contraindicate to immunotherapy. * Patients cannot fully cooperate with HIT and follow-up. * Pregnant or lactating women. * Other circumstances may affect the results.
References
Publications (0)
Data not yet available