Overview
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.
Description
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.
Eligibility
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.