Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases

Sponsor
China Medical University, China
Study ID
NCT07118566
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Cancer
  • Immunotherapy
  • Liver Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperthermia — PROCEDURE
    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.
  • Immunotherapy — DRUG
    iv，d1，q3w

Study Details

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.

Key Dates

First listed
Aug 12, 2025
Start date
Aug 15, 2025
Status verified
May 2025
Primary completion
May 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: gastric cancer
    Gastric cancer patients must have received at least one prior line of systemic therapy.
  • Experimental: Cohort 2: colorectal cancer
    Colorectal cancer patients must have received at least two prior lines of systemic therapy.

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). ]

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