An observational study in Advanced Solid Tumors and Advanced Solid Tumors Cancer, sponsored by Zhejiang Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Zhejiang Hospital · Observational
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.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
This study's planned enrollment of 500 is above the median of 151 across 61 observational studies indexed under Cancer Pain.
Browse Cancer Pain studies →Zhejiang Hospital is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 , including unresectable locally advanced, recurrent, or 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 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.
Exclusion Criteria:
No confirmed malignant solid tumor, including participants treated only for a benign condition or a hematologic .
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 , unless continued use of previously collected data is permitted by the participant and the ethics review committee.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
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 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.
Time frame: 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.
Time frame: 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.
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.
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.
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.
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: From the first hyperthermia session until death from any cause, assessed for up to 12 months.
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