A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Trial Parameters
Brief Summary
This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years, female gender; 2. Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection; 3. The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm; 4. At least an interval of 1 month since the last local treatment; 5. Child-Pugh class A or B; 6. ECOG PS score ≤2, with an expected survival of \>3 months. Exclusion Criteria: 1. Liver function Child-Pugh class C; 2. Systemic widespread metastasis, with an expected survival of \< 3 months; 3. History of esophageal (gastric fundus) variceal bleeding within the past month; 4. Dysfunction or failure of vital organs; 5. Presence of an active infection; 6. Irreparable coagulation abnormality; 7. Refractory massive ascites, pleural effusion or cachexia; 8. Pregnancy, altered consciousness or patients unable to cooperate with treatment; 9. Previously participated in other clinical studies and still within the follow-up period; 10. Any other fa