A Phase 2 interventional study of Hyperthermia and Immunotherapy in Gastrointestinal Cancer, Immunotherapy and Liver Metastasis, sponsored by China Medical University, China. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by China Medical University, China · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Gastric cancer patients must have received at least one prior line of systemic therapy.
Procedure: Hyperthermia · Drug: Immunotherapy
Colorectal cancer patients must have received at least two prior lines of systemic therapy.
Procedure: Hyperthermia · Drug: Immunotherapy
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.
Also known as: Microwave hyperthermia
iv，d1，q3w
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).
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).
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
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).
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.
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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China Medical University, China