A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Anti-tumor immune response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anti-tumor immune response
时间窗: max 24 months
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.
次要结局
- 6-Month Progression-Free Survival(6 months)
- 1-Year Overall Survival(1 year)
- 6-Month Local Control Rate(6 months)
- 1-Year Progression-Free Survival(1 year)