Gastrointestinal TumorPhase 1/2HEAIS001NCT06022692
Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours
A Phase 1/2 study testing Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany) and tislelizumab (BeiGene, China) combined with PD-1 inhibitor in people with Gastrointestinal Tumor, run by Pengyuan Liu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Tumor
- What is being tested?
- Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany) and tislelizumab (BeiGene, China) combined with PD-1 inhibitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The specific treatment process is shown in the trial flow diagram. The patients underwent WIRA whole-body hyperthermia on days 1 and 8 of each HIT cycle. On day 2 (24 h after hyperthermia on day 1), 200 mg of tislelizumab prepared with 100 mL of normal saline was intravenously administered for less than 30 min. After six HIT cycles, tislelizumab was administered intravenously every 21 days until drop-out. For quality control of hyperthermia, the core temperature was set to 38·5-39·5 °C and measured using a rectal temperature-sensing probe. Hyperthermia was considered to have been achieved when this temperature range was recached and maintained for 60 min. Each hyperthermia session lasted for 2 h, including a 30-min heating stage, a 60-min insulation stage, and a 30-min cooling stage. Clinical data were collected every two HIT treatment cycles and evaluated using the RECIST version 1.1 standard.
- Conditions
- Gastrointestinal Tumor
- Being tested
- Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany), tislelizumab (BeiGene, China) combined with PD-1 inhibitor
- Keywords
- hyperthermia, immune checkpoint inhibitor
- Medical subject headings
- Digestive System Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany)Device
The patients were treated with whole-body hyperthermia (HECKEL 3000MT-4T, Germany)) on days 1 and 8 of each hyperthermia combined with immune checkpoint inhibitor treatment cycle along with administration of tislelizumab (BeiGene, China) 200 mg on day 2 (24 hours after the hyperthermia at day 1).
tislelizumab (BeiGene, China) combined with PD-1 inhibitorDrug
Also called Immune checkpoint inhibitor, PD-1 antibody
The patients were treated with whole-body hyperthermia (HECKEL 3000MT-4T, Germany)) on days 1 and 8 of each hyperthermia combined with immune checkpoint inhibitor treatment cycle along with administration of tislelizumab (BeiGene, China) 200 mg on day 2 (24 hours after the hyperthermia at day 1).
| Study group | Role | What they receive |
|---|---|---|
| hyperthermia combined with immune checkpoint inhibitor group | Experimental | 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). Receives: Device: Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany); Drug: tislelizumab (BeiGene, China) combined with PD-1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate (DCR)
DCR=(PR+CR) / (PD+SD+PR+CR) * 100%
Measured: up to 6 months
Secondary outcomes (2)
progression-free survival (PFS)
The time between enrollment and tumor progression (in any aspect) or death (for any reason).
Measured: up to 36 months
overall survival (OS)
The time between enrollment and death (for any reason).
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Jun 2020
- Primary completion31 May 2022
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pengyuan Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Hospital
- Responsible party
- Sponsor-investigator, Pengyuan Liu, Zhejiang Hospital
- Investigators
- Jun Chen, Study director, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022692
- Sponsor's protocol ID
- ZhejiangH
- Acronym
- HEAIS001
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06022692
- Acronym / sponsor ID
- HEAIS001 / ZhejiangH
- Conditions
- Gastrointestinal Tumor
- Keywords
- hyperthermia, immune checkpoint inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pengyuan LiuUniversity, hospital or other
- Collaborators
- Zhejiang Hospital
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific treatment process is shown in the trial flow diagram. The patients underwent WIRA whole-body hyperthermia on days 1 and 8 of each HIT cycle. On day 2 (24 h after hyperthermia on day 1), 200 mg of tislelizumab prepared with 100 mL of normal saline was intravenously administered for less than 30 min. After six HIT cycles, tislelizumab was administered intravenously every 21 days until drop-out. For quality control of hyperthermia, the core temperature was set to 38·5-39·5 °C and measured using a rectal temperature-sensing probe. Hyperthermia was considered to have been achieved when this temperature range was recached and maintained for 60 min. Each hyperthermia session lasted for 2 h, including a 30-min heating stage, a 60-min insulation stage, and a 30-min cooling stage. Clinical data were collected every two HIT treatment cycles and evaluated using the RECIST version 1.1 standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperthermia combined with immune checkpoint inhibitor group | Experimental | Device: Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany), Drug: tislelizumab (BeiGene, China) combined with PD-1 inhibitorThe 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany)The patients were treated with whole-body hyperthermia (HECKEL 3000MT-4T, Germany)) on days 1 and 8 of each hyperthermia combined with immune checkpoint inhibitor treatment cycle along with administration of tislelizumab (BeiGene, China) 200 mg on day 2 (24 hours after the hyperthermia at day 1). | Device | hyperthermia combined with immune checkpoint inhibitor group |
| tislelizumab (BeiGene, China) combined with PD-1 inhibitorAlso: Immune checkpoint inhibitor, PD-1 antibodyThe patients were treated with whole-body hyperthermia (HECKEL 3000MT-4T, Germany)) on days 1 and 8 of each hyperthermia combined with immune checkpoint inhibitor treatment cycle along with administration of tislelizumab (BeiGene, China) 200 mg on day 2 (24 hours after the hyperthermia at day 1). | Drug | hyperthermia combined with immune checkpoint inhibitor group |
Primary outcome
disease control rate (DCR)
Time frame: up to 6 months
DCR=(PR+CR) / (PD+SD+PR+CR) * 100%
2 secondary outcomes
progression-free survival (PFS)
Time frame: up to 36 months
overall survival (OS)
Time frame: up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Chen study director
Zhejiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany) and tislelizumab (BeiGene, China) combined with PD-1 inhibitor in people with Gastrointestinal Tumor, run by Pengyuan Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate (DCR) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.