Advanced Solid TumorsHEAIS-009NCT07793214
ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors
An observational study of Advanced Solid Tumors and Advanced Solid Tumors Cancer, run by Zhejiang Hospital at 1 site in China.
Trial summary
This ambispective observational cohort study will evaluate biological changes, palliative outcomes, and safety associated with ET-SPACE whole-body infrared hyperthermia in patients with advanced solid tumors. This noninvasive treatment uses infrared energy to raise body temperature in a controlled manner. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Solid Tumors, Advanced Solid Tumors Cancer
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise consecutive adults with unresectable locally advanced, recurrent, or metastatic solid tumors who initiated at least one session of ET-SPACE whole-body infrared hyperthermia at Zhejiang Hospital between January 1, 2022, and December 31, 2028. Retrospective participants will be identified from electronic medical records and hyperthermia treatment records, while prospective participants will be consecutively enrolled and followed using the same eligibility criteria. No restrictions will be imposed based on sex, primary tumor type, metastatic site, treatment line, previous or concomitant anticancer therapy, performance status, comorbidities, or number of hyperthermia sessions. Participants with missing individual laboratory tests, questionnaires, imaging assessments, or follow-up variables will remain eligible, provided that the diagnosis and hyperthermia exposure can be confirmed.
Who may be able to join
- Age 18 years or older at the time of the first whole-body infrared hyperthermia session.
- Histologically, cytologically, or clinically and radiologically confirmed advanced solid malignancy, including unresectable locally advanced, recurrent, or metastatic disease.
- Initiated at least one session of ET-SPACE whole-body infrared hyperthermia at Zhejiang Hospital between January 1, 2022, and December 31, 2028, as part of routine clinical care. Participants whose treatment was interrupted or not completed may also be included.
- Medical records contain sufficient information to confirm the diagnosis of a solid malignancy and exposure to ET-SPACE whole-body infrared hyperthermia. Missing individual laboratory tests, questionnaires, imaging assessments, or follow-up variables will not by itself result in exclusion.
- For the prospective component, written informed consent is provided by the participant or a legally authorized representative. For the retrospective component, informed consent is waived or obtained in accordance with the approval of the institutional ethics review committee.
- Participants are eligible regardless of sex, primary tumor type, metastatic site, treatment line, previous or concomitant anticancer therapy, performance status, comorbidities, or number of hyperthermia sessions.
Who cannot join
- No confirmed malignant solid tumor, including participants treated only for a benign condition or a hematologic malignancy.
- ET-SPACE whole-body infrared hyperthermia was planned but never initiated, or only local or regional hyperthermia was administered.
- Available records are insufficient to confirm the participant's identity, diagnosis of a solid malignancy, or initiation of ET-SPACE whole-body infrared hyperthermia.
- Duplicate records or repeated registrations of the same participant; only one consolidated participant record will be included.
- For the prospective component, refusal or withdrawal of informed consent, unless continued use of previously collected data is permitted by the participant and the ethics review committee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Hospital, Department of Oncology, Hangzhou, China, 310030
Hangzhou, Zhejiang, 310030
Pengyuan Liu, Dr., +86-18368846455, oncologyliupengyuan@outlook.com
About this study
Official title: Metabolic Reprogramming, Immune Modulation, and Palliative Outcomes Associated With ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors: An Ambispective Observational Cohort Study
This ambispective observational cohort study will evaluate biological changes, palliative outcomes, and safety associated with ET-SPACE whole-body infrared hyperthermia in patients with advanced solid tumors. This noninvasive treatment uses infrared energy to raise body temperature in a controlled manner. Patients who received the treatment between January 1, 2022, and December 31, 2028, will be included. Earlier cases will be assessed retrospectively using medical records, while subsequently enrolled patients will be followed prospectively. Hyperthermia and all anticancer or supportive treatments will be provided according to routine clinical practice and will not be assigned by the study.
The study will collect patient and tumor characteristics, laboratory findings, anticancer and supportive treatments, hyperthermia parameters, adverse events, and follow-up outcomes. It will assess changes in metabolism-related indicators, immune and inflammatory function, nutritional status, quality of life, cancer-related pain, functional status, symptom burden, and tumor-specific palliative scores. The study will also explore factors associated with more favorable outcomes and clarify the potential supportive and palliative role of whole-body infrared hyperthermia in patients with advanced solid tumors.
- Keywords
- Whole-Body Infrared Hyperthermia, ET-SPACE, Metabolic Reprogramming, Immune Modulation, Palliative Care, Quality of Life, Cancer Pain, Nutritional Status
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ET-SPACE Whole-Body Infrared Hyperthermia Cohort | Patients with advanced solid tumors who received ET-SPACE whole-body infrared hyperthermia as part of routine clinical care between January 1, 2022, and December 31, 2028. Participants will be identified retrospectively from existing medical records or followed prospectively. Clinical, laboratory, treatment, safety, symptom, quality-of-life, nutritional, immune, inflammatory, and metabolism-related data will be collected before and after hyperthermia, when available. Hyperthermia exposure and all concomitant anticancer or supportive treatments are determined by the treating physicians and are not assigned by the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Prognostic Nutritional Index at Week 4
The Prognostic Nutritional Index will be calculated as serum albumin in grams per liter plus five multiplied by the absolute lymphocyte count in 10^9 cells per liter. Higher values generally indicate better nutritional and immunological status.
Measured: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Mean Change From Baseline in Cancer Pain Intensity at Week 4
Cancer-related pain will be assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The outcome will be calculated as the Week 4 score minus the baseline score.
Measured: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Week 12
The EORTC QLQ-C30 global health status scale ranges from 0 to 100, with higher scores indicating better overall health and quality of life. This outcome evaluates the durability of quality-of-life changes.
Measured: Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.
Mean Change From Baseline in Edmonton Symptom Assessment System-Revised Total Score at Week 4
The Edmonton Symptom Assessment System-Revised evaluates nine common symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden.
Measured: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Change From Baseline in Eastern Cooperative Oncology Group Performance Status at Week 4
Eastern Cooperative Oncology Group performance status ranges from 0 to 5, with higher grades indicating poorer functional status. Improvement is defined as a decrease of one or more grades, deterioration as an increase of one or more grades, and stability as no change.
Measured: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Mean Change From Baseline in Systemic Immune-Inflammation Index
The Systemic Immune-Inflammation Index will be calculated as the peripheral platelet count multiplied by the neutrophil count and divided by the lymphocyte count. The outcome will evaluate acute and short-term changes in systemic immune-inflammatory status.
Measured: Baseline within 7 days before the first hyperthermia session, 24 to 72 hours after the first session, and Week 4, plus or minus 7 days.
Mean Change From Baseline in Peripheral Blood CD4 to CD8 T-Cell Ratio
The ratio of CD4-positive T lymphocytes to CD8-positive T lymphocytes will be measured by flow cytometry when available. The outcome will evaluate changes in peripheral cellular immune status.
Measured: Baseline within 7 days before the first hyperthermia session, 24 to 72 hours after the first session, and Week 4, plus or minus 7 days.
Secondary outcomes (7)
Change From Baseline in Patient-Generated Subjective Global Assessment Nutritional Category
Nutritional status will be classified using the Patient-Generated Subjective Global Assessment as Category A, well nourished; Category B, moderately or suspected of being malnourished; or Category C, severely malnourished. Changes between categories will be reported.
Measured: Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.
Mean Change From Baseline in Daily Oral Morphine Equivalent Dose at Week 4
Daily opioid consumption will be converted to oral morphine equivalent dose in milligrams per day using standardized conversion factors. The outcome will evaluate changes in analgesic requirements.
Measured: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Number of Participants With Whole-Body Infrared Hyperthermia-Related Adverse Events
Adverse events considered possibly, probably, or definitely related to whole-body infrared hyperthermia will be recorded and graded according to the Common Terminology Criteria for Adverse Events version 5.0. The number and percentage of participants experiencing any adverse event and Grade 3 or higher adverse events will be reported.
Measured: From the first hyperthermia session through 30 days after the final hyperthermia session, assessed for up to 16 weeks.
Response Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1
Objective response rate is defined as the percentage of evaluable participants whose best overall response is complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1. Tumor response may reflect all concomitant anticancer treatments received during the observation period.
Measured: From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.
Disease Control Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1
Disease control rate is defined as the percentage of evaluable participants whose best overall response is complete response, partial response, or stable disease according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.
Progression-Free Survival
Progression-free survival is defined as the time from the first whole-body infrared hyperthermia session to the first documented disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last evaluable disease assessment.
Measured: From the first hyperthermia session until disease progression or death, assessed for up to 12 months.
Overall Survival
Overall survival is defined as the time from the first whole-body infrared hyperthermia session to death from any cause. Participants who remain alive will be censored at the date they were last known to be alive.
Measured: From the first hyperthermia session until death from any cause, assessed for up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pengyuan Liu, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793214
- Sponsor's protocol ID
- HEAIS-009
- Acronym
- HEAIS-009
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Reprogramming, Immune Modulation, and Palliative Outcomes Associated With ET-SPACE Whole-Body Infrared Hyperthermia in Patients With Advanced Solid Tumors: An Ambispective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07793214
- Acronym / sponsor ID
- HEAIS-009 / HEAIS-009
- Keywords
- Whole-Body Infrared Hyperthermia, ET-SPACE, Metabolic Reprogramming, Immune Modulation, Palliative Care, Quality of Life, Cancer Pain, Nutritional Status
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Aug 2026 (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.
This ambispective observational cohort study will evaluate biological changes, palliative outcomes, and safety associated with ET-SPACE whole-body infrared hyperthermia in patients with advanced solid tumors. This noninvasive treatment uses infrared energy to raise body temperature in a controlled manner. Patients who received the treatment between January 1, 2022, and December 31, 2028, will be included. Earlier cases will be assessed retrospectively using medical records, while subsequently enrolled patients will be followed prospectively. Hyperthermia and all anticancer or supportive treatments will be provided according to routine clinical practice and will not be assigned by the study.
The study will collect patient and tumor characteristics, laboratory findings, anticancer and supportive treatments, hyperthermia parameters, adverse events, and follow-up outcomes. It will assess changes in metabolism-related indicators, immune and inflammatory function, nutritional status, quality of life, cancer-related pain, functional status, symptom burden, and tumor-specific palliative scores. The study will also explore factors associated with more favorable outcomes and clarify the potential supportive and palliative role of whole-body infrared hyperthermia in patients with advanced solid tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ET-SPACE Whole-Body Infrared Hyperthermia Cohort | – | –Patients with advanced solid tumors who received ET-SPACE whole-body infrared hyperthermia as part of routine clinical care between January 1, 2022, and December 31, 2028. Participants will be identified retrospectively from existing medical records or followed prospectively. Clinical, laboratory, treatment, safety, symptom, quality-of-life, nutritional, immune, inflammatory, and metabolism-related data will be collected before and after hyperthermia, when available. Hyperthermia exposure and all concomitant anticancer or supportive treatments are determined by the treating physicians and are not assigned by the study protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise consecutive adults with unresectable locally advanced, recurrent, or metastatic solid tumors who initiated at least one session of ET-SPACE whole-body infrared hyperthermia at Zhejiang Hospital between January 1, 2022, and December 31, 2028. Retrospective participants will be identified from electronic medical records and hyperthermia treatment records, while prospective participants will be consecutively enrolled and followed using the same eligibility criteria. No restrictions will be imposed based on sex, primary tumor type, metastatic site, treatment line, previous or concomitant anticancer therapy, performance status, comorbidities, or number of hyperthermia sessions. Participants with missing individual laboratory tests, questionnaires, imaging assessments, or follow-up variables will remain eligible, provided that the diagnosis and hyperthermia exposure can be confirmed.
Key inclusion criteria (6 listed)
- Age 18 years or older at the time of the first whole-body infrared hyperthermia session.
- Histologically, cytologically, or clinically and radiologically confirmed advanced solid malignancy, including unresectable locally advanced, recurrent, or metastatic disease.
- Initiated at least one session of ET-SPACE whole-body infrared hyperthermia at Zhejiang Hospital between January 1, 2022, and December 31, 2028, as part of routine clinical care. Participants whose treatment was interrupted or not completed may also be included.
- Medical records contain sufficient information to confirm the diagnosis of a solid malignancy and exposure to ET-SPACE whole-body infrared hyperthermia. Missing individual laboratory tests, questionnaires, imaging assessments, or follow-up variables will not by itself result in exclusion.
- For the prospective component, written informed consent is provided by the participant or a legally authorized representative. For the retrospective component, informed consent is waived or obtained in accordance with the approval of the institutional ethics review committee.
Key exclusion criteria (5 listed)
- No confirmed malignant solid tumor, including participants treated only for a benign condition or a hematologic malignancy.
- ET-SPACE whole-body infrared hyperthermia was planned but never initiated, or only local or regional hyperthermia was administered.
- Available records are insufficient to confirm the participant's identity, diagnosis of a solid malignancy, or initiation of ET-SPACE whole-body infrared hyperthermia.
- Duplicate records or repeated registrations of the same participant; only one consolidated participant record will be included.
- For the prospective component, refusal or withdrawal of informed consent, unless continued use of previously collected data is permitted by the participant and the ethics review committee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Change From Baseline in Prognostic Nutritional Index at Week 4
Time frame: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
The Prognostic Nutritional Index will be calculated as serum albumin in grams per liter plus five multiplied by the absolute lymphocyte count in 10^9 cells per liter. Higher values generally indicate better nutritional and immunological status.
Mean Change From Baseline in Cancer Pain Intensity at Week 4
Time frame: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Cancer-related pain will be assessed using an 11-point Numeric Rating Scale ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. The outcome will be calculated as the Week 4 score minus the baseline score.
Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Week 12
Time frame: Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.
The EORTC QLQ-C30 global health status scale ranges from 0 to 100, with higher scores indicating better overall health and quality of life. This outcome evaluates the durability of quality-of-life changes.
Mean Change From Baseline in Edmonton Symptom Assessment System-Revised Total Score at Week 4
Time frame: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
The Edmonton Symptom Assessment System-Revised evaluates nine common symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden.
Change From Baseline in Eastern Cooperative Oncology Group Performance Status at Week 4
Time frame: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Eastern Cooperative Oncology Group performance status ranges from 0 to 5, with higher grades indicating poorer functional status. Improvement is defined as a decrease of one or more grades, deterioration as an increase of one or more grades, and stability as no change.
Mean Change From Baseline in Systemic Immune-Inflammation Index
Time frame: Baseline within 7 days before the first hyperthermia session, 24 to 72 hours after the first session, and Week 4, plus or minus 7 days.
The Systemic Immune-Inflammation Index will be calculated as the peripheral platelet count multiplied by the neutrophil count and divided by the lymphocyte count. The outcome will evaluate acute and short-term changes in systemic immune-inflammatory status.
Mean Change From Baseline in Peripheral Blood CD4 to CD8 T-Cell Ratio
Time frame: Baseline within 7 days before the first hyperthermia session, 24 to 72 hours after the first session, and Week 4, plus or minus 7 days.
The ratio of CD4-positive T lymphocytes to CD8-positive T lymphocytes will be measured by flow cytometry when available. The outcome will evaluate changes in peripheral cellular immune status.
7 secondary outcomes
Change From Baseline in Patient-Generated Subjective Global Assessment Nutritional Category
Time frame: Baseline within 7 days before the first hyperthermia session and Week 12, plus or minus 14 days, after the first session.
Mean Change From Baseline in Daily Oral Morphine Equivalent Dose at Week 4
Time frame: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.
Number of Participants With Whole-Body Infrared Hyperthermia-Related Adverse Events
Time frame: From the first hyperthermia session through 30 days after the final hyperthermia session, assessed for up to 16 weeks.
Response Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.
Disease Control Rate According to Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: From the first hyperthermia session through the first scheduled tumor assessment at Week 12, plus or minus 14 days.
Progression-Free Survival
Time frame: From the first hyperthermia session until disease progression or death, assessed for up to 12 months.
Overall Survival
Time frame: From the first hyperthermia session until death from any cause, assessed for up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumors and Advanced Solid Tumors Cancer, run by Zhejiang Hospital 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengyuan Liu, Dr. (+86-18368846455, oncologyliupengyuan@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Prognostic Nutritional Index at Week 4 (time frame: Baseline within 7 days before the first hyperthermia session and Week 4, plus or minus 7 days, after the first session.). The study lists 7 primary outcomes in all. 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 28 Aug 2026.