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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-mode ablation | Experimental | Subjects in this arm will receive image-guided multi-mode ablation. |
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| Conventional radiofrequency ablation | Active Comparator | Subjects in this arm will receive image-guided radiofrequency ablation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-mode tumor treatment system | Device | All subjects are treated using the multi-mode tumor treatment system (Shanghai MAaGI Medical Technology Co., Ltd), with the treatment procedure conducted according to the temperature control mode for tumor ablation. The treatment procedure includes: rapid freezing of the tumor tissue to form an ice ball extending 5mm beyond the lesion, maintaining this state for 5 minutes, followed by thawing and rewarming; subsequently, RFA is performed to ensure complete ablation, with the ablation zone including a safety margin of 5-10mm around the tumor. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-tumor immune response | The anti-tumor immune response refers to the effect and mechanism by which multi-mode ablation activates systemic persistent specific anti-tumor immunity, thereby inhibiting tumor metastasis and recurrence. | max 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Month Local Control Rate | 6-month local control rate (LCR) refers to the proportion of patients in whom the primary tumor site lesions are completely suppressed after treatment among all treated patients six months after the start of treatment. | 6 months |
| 6-Month Progression-Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Radiofrequency ablation therapeutic apparatus | Device | All subjects are treated using the radiofrequency ablation therapeutic apparatus (MedSphere International (Shanghai) Co., Ltd.), with the treatment procedure conducted according to the preset power and time parameters to ensure a safety margin of 5-10mm. |
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6-month progression-free survival (6-month PFS) refers to the percentage of patients who are alive without tumor progression or metastasis six months after the start of treatment. |
| 6 months |
| 1-Year Progression-Free Survival | 1-year progression-free survival (1-year PFS) refers to the percentage of patients who are alive without tumor progression or metastasis one year after the start of treatment. | 1 year |
| 1-Year Overall Survival | 1-year overall survival (1-year OS) refers to the percentage of patients who are still alive one year after the start of treatment. | 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |