Gastrointestinal CancerPhase 2NCT07118566
Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases
A Phase 2 study testing Hyperthermia and Immunotherapy in people with Gastrointestinal Cancer and Immunotherapy, run by China Medical University, China.
Trial summary
This study aims to explore the synergistic antitumor effects and safety of hyperthermia combined with immune checkpoint inhibitors (ICIs) in patients with advanced gastrointestinal malignancies with liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Cancer, Immunotherapy, Liver Metastasis
- What is being tested?
- Hyperthermia and Immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to Sep 2029
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years, male or female.
- Histologically or cytologically confirmed diagnosis of gastrointestinal malignancy with liver metastases.
- Prior treatment requirements:
- Gastric cancer patients must have received at least one prior line of systemic therapy.
- Colorectal cancer patients must have received at least two prior lines of systemic therapy.
- Clinically assessed as suitable for hyperthermia combined with immune checkpoint inhibitor therapy.
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- At least one measurable lesion meeting RECIST 1.1 criteria.
- Expected survival ≥6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate organ and bone marrow function.
- Willingness to provide sufficient baseline and post-treatment samples, ability to comply with long-term follow-up and evaluation, and signed informed consent.
- No prior history of other malignancies.
Who cannot join
- Pregnant or lactating women.
- Any comorbidities or underlying medical conditions that, in the investigator's judgment, render the patient unsuitable for study participation.
- Presence of other severe physical or psychiatric disorders, or clinically significant laboratory abnormalities that may increase the risk associated with study participation, interfere with study results interpretation, or otherwise make the patient inappropriate for inclusion as determined by the investigator.
About this study
Official title: Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases: A Multicenter, Open-label, Dual-cohort Phase II Exploratory Clinical Study
This study aims to explore the synergistic antitumor effects and safety of hyperthermia combined with immune checkpoint inhibitors (ICIs) in patients with advanced gastrointestinal malignancies with liver metastases. Liver metastasis represents a common cause of treatment failure in gastrointestinal cancers, and the response rate to ICIs remains suboptimal in certain patients with liver metastases, potentially attributable to the immunosuppressive hepatic microenvironment. The combination of hyperthermia with ICIs, chemotherapy, or other therapeutic modalities may further enhance treatment efficacy. Hyperthermia could potentially reverse immunosuppression and improve ICI effectiveness through mechanisms including enhanced tumor blood perfusion, promoted antigen presentation, and increased immune cell infiltration. This multicenter, open-label, dual-cohort phase II trial will evaluate patients stratified by tumor type (colorectal cancer versus gastric cancer) to assess the objective response rate (ORR), progression-free survival (PFS), and safety profile of hyperthermia-ICI combination therapy. Concurrently, dynamic monitoring of peripheral immune markers (such as neutrophil-to-lymphocyte ratio and interleukins) and tumor microenvironment alterations will be conducted to identify potential predictive biomarkers, thereby providing preliminary evidence for subsequent phase III investigations. The ultimate objective is to develop more effective combination treatment strategies for patients with advanced gastrointestinal malignancies accompanied by liver metastases.
- Conditions
- Gastrointestinal Cancer, Immunotherapy, Liver Metastasis
- Being tested
- Hyperthermia, Immunotherapy
- Keywords
- gastrointestinal cancer, immunotherapy, liver metastasis, hyperthermia
- Medical subject headings
- Gastrointestinal Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaProcedure or surgery
Also called Microwave hyperthermia
Each session of hyperthermia should be spaced at least 24 hours apart, with at least one session administered prior to ICI (immune checkpoint inhibitor) treatment. Five times q3w.
ImmunotherapyDrug
iv，d1，q3w
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: gastric cancer | Experimental | Gastric cancer patients must have received at least one prior line of systemic therapy. Receives: Procedure: Hyperthermia; Drug: Immunotherapy |
| Cohort 2: colorectal cancer | Experimental | Colorectal cancer patients must have received at least two prior lines of systemic therapy. Receives: Procedure: Hyperthermia; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (ORR) refers to the proportion of patients whose tumor volume has shrunk to the pre-specified value and can maintain the minimum duration requirement (at least 4 weeks, assessed up to 12 months) by the RECIST (Version 1.1), which is the sum of the proportions of complete response (CR) and partial response (PR).
Measured: From the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 months).
Secondary outcomes (3)
Progression Free Survival
Measured: Progression-free survival (PFS) refers to the time from the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 months).
Disease Control Rate
Disease control rate (DCR) refers to the proportion of patients whose tumor volume has shrunk to the pre-specified value and can maintain the minimum duration requirement (at least 4 weeks, assessed up to 12 months) by the RECIST (Version 1.1), which is the sum of the proportions of complete response (CR), partial response (PR), and stable disease (SD).
Measured: From the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 months).
Overall Survival
Measured: From study enrollment through 12 months post-treatment completion of the last participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujuan Qu, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118566
- Sponsor's protocol ID
- CLOG-2025GI-HT01
- Status last verified
- May 2025
- First submitted
- 28 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases: A Multicenter, Open-label, Dual-cohort Phase II Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07118566
- Acronym / sponsor ID
- CLOG-2025GI-HT01
- Conditions
- Gastrointestinal Cancer, Immunotherapy, Liver Metastasis
- Keywords
- gastrointestinal cancer, immunotherapy, liver metastasis, hyperthermia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Aug 2025 (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 study aims to explore the synergistic antitumor effects and safety of hyperthermia combined with immune checkpoint inhibitors (ICIs) in patients with advanced gastrointestinal malignancies with liver metastases. Liver metastasis represents a common cause of treatment failure in gastrointestinal cancers, and the response rate to ICIs remains suboptimal in certain patients with liver metastases, potentially attributable to the immunosuppressive hepatic microenvironment. The combination of hyperthermia with ICIs, chemotherapy, or other therapeutic modalities may further enhance treatment efficacy. Hyperthermia could potentially reverse immunosuppression and improve ICI effectiveness through mechanisms including enhanced tumor blood perfusion, promoted antigen presentation, and increased immune cell infiltration. This multicenter, open-label, dual-cohort phase II trial will evaluate patients stratified by tumor type (colorectal cancer versus gastric cancer) to assess the objective response rate (ORR), progression-free survival (PFS), and safety profile of hyperthermia-ICI combination therapy. Concurrently, dynamic monitoring of peripheral immune markers (such as neutrophil-to-lymphocyte ratio and interleukins) and tumor microenvironment alterations will be conducted to identify potential predictive biomarkers, thereby providing preliminary evidence for subsequent phase III investigations. The ultimate objective is to develop more effective combination treatment strategies for patients with advanced gastrointestinal malignancies accompanied by liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: gastric cancer | Experimental | Procedure: Hyperthermia, Drug: ImmunotherapyGastric cancer patients must have received at least one prior line of systemic therapy. |
| Cohort 2: colorectal cancer | Experimental | Procedure: Hyperthermia, Drug: ImmunotherapyColorectal cancer patients must have received at least two prior lines of systemic therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18 and 75 years, male or female.
- Histologically or cytologically confirmed diagnosis of gastrointestinal malignancy with liver metastases.
- Prior treatment requirements:
- Gastric cancer patients must have received at least one prior line of systemic therapy.
- Colorectal cancer patients must have received at least two prior lines of systemic therapy.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Any comorbidities or underlying medical conditions that, in the investigator's judgment, render the patient unsuitable for study participation.
- Presence of other severe physical or psychiatric disorders, or clinically significant laboratory abnormalities that may increase the risk associated with study participation, interfere with study results interpretation, or otherwise make the patient inappropriate for inclusion as determined by the investigator.
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 |
|---|---|---|
| HyperthermiaAlso: Microwave hyperthermiaEach session of hyperthermia should be spaced at least 24 hours apart, with at least one session administered prior to ICI (immune checkpoint inhibitor) treatment. Five times q3w. | Procedure or surgery | Cohort 1: gastric cancer, Cohort 2: colorectal cancer |
| Immunotherapyiv，d1，q3w | Drug | Cohort 1: gastric cancer, Cohort 2: colorectal cancer |
Primary outcome
Objective Response Rate
Time frame: From the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 months).
Objective response rate (ORR) refers to the proportion of patients whose tumor volume has shrunk to the pre-specified value and can maintain the minimum duration requirement (at least 4 weeks, assessed up to 12 months) by the RECIST (Version 1.1), which is the sum of the proportions of complete response (CR) and partial response (PR).
3 secondary outcomes
Progression Free Survival
Time frame: Progression-free survival (PFS) refers to the time from the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 months).
Disease Control Rate
Time frame: From the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 months).
Overall Survival
Time frame: From study enrollment through 12 months post-treatment completion of the last participant.
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 12 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperthermia and Immunotherapy in people with Gastrointestinal Cancer and Immunotherapy, run by China Medical University, 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 12 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
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?
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?
Objective Response Rate (time frame: From the start of treatment to tumor progression or death from any cause (whichever occurs first, at least 4 weeks, assessed up to 12 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 12 Aug 2025.