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

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.