NCT07459309招募中不适用
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ablation efficacy rate at 1 month postoperatively
研究概览
简要总结
Clinical Study on the Safety, Efficacy, and Exploration of Immune Mechanisms of a Combined Multimodal Tumor Therapy System for Hepatic Malignancies
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, regardless of gender;
- •Histopathologically confirmed or clinically diagnosed hepatic malignancies, including primary liver cancer and metastatic liver cancer;
- •Presence of an image-evaluable target lesion for ablation, with the maximum diameter of the target lesion being 3-5 cm;
- •Patient is intolerant to or refuses surgical resection;
- •ECOG performance status score ≤ 2, with an expected survival period of greater than 3 months.
排除标准
- •Liver function classified as Child-Pugh C, unimprovable with hepatoprotective therapy;
- •Massive or diffuse hepatocellular carcinoma;
- •Presence of vascular tumor thrombus or invasion of adjacent organs;
- •History of esophageal (gastric fundus) variceal rupture and bleeding within 1 month prior to treatment;
- •Uncorrectable coagulation dysfunction and severe hematological abnormalities, with a high risk of severe bleeding;
- •Refractory massive ascites, cachexia;
- •Active infection, especially inflammatory conditions of the biliary system;
- •Severe functional failure of major organs such as liver, kidney, heart, lung, and brain;
- •Impaired consciousness, or inability to cooperate with treatment;
- •Previous systemic treatments (e.g., chemotherapy) with an interval of less than 2 weeks and not having recovered from prior treatment: CTCAE 6.0 grade >1 (except for alopecia);
- •Any other factors deemed by the investigator to make the subject unsuitable for participation or to affect the subject's involvement in the study.
研究组 & 干预措施
Treatment Group
Experimental
Multimodal Tumor Thermal Ablation
干预措施: Multimodal Tumor Thermal Ablation (Device)
结局指标
主要结局
Ablation efficacy rate at 1 month postoperatively
时间窗: 1 month after ablation
Ablation efficacy rate at 1 month postoperatively
次要结局
- Changes in the Peripheral Blood Immune Microenvironment Before and After Treatment(1 month after ablation)
- Adverse events and serious adverse events(1 month)
研究者
Wen-Tao Li
Director of Interventional Therapy Department,Fudan University
Fudan University
研究点 (1)
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