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Not yet recruiting NCT07118566

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

Phase II Interventional Gastrointestinal Cancer Immunotherapy Liver Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperthermia, Immunotherapy.
Who it may be relevant to
Registry conditions: Gastrointestinal Cancer, Immunotherapy, Liver Metastasis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure 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.
  • Drug Immunotherapy
    iv，d1，q3w

Primary outcome measures

  • 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).]
Secondary outcome measures (3)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07118566 · CLOG-2025GI-HT01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗