A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases

This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.

Inclusion criteria

• Age 18-75 years, female gender;
• Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection;
• The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
• At least an interval of 1 month since the last local treatment;
• Child-Pugh class A or B;
• ECOG PS score ≤2, with an expected survival of >3 months.

Exclusion criteria

• Liver function Child-Pugh class C;
• Systemic widespread metastasis, with an expected survival of < 3 months;
• History of esophageal (gastric fundus) variceal bleeding within the past month;
• Dysfunction or failure of vital organs;
• Presence of an active infection;
• Irreparable coagulation abnormality;
• Refractory massive ascites, pleural effusion or cachexia;
• Pregnancy, altered consciousness or patients unable to cooperate with treatment;
• Previously participated in other clinical studies and still within the follow-up period;
• Any other factors deemed inappropriate for inclusion or that may affect the patient's participation in the study, as determined by the investigator.