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临床试验/NCT04044326
NCT04044326撤回不适用

The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors Closed to Inferior Vena Cava

National Taiwan University Hospital2 个研究点 分布在 1 个国家开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria

研究概览

简要总结

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Several pre-clinical studies have already demonstrated microwave ablation (MWA) is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE (Conformité Européenne) mark and U.S. Food and Drug Administration (FDA) approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, the researchers will perform MWA for 20 inoperable patients with liver cancers adjacent to inferior vena cava (IVC). The researchers will appraisal the clinical feasibility and advantage of the system by this study.

详细描述

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor location. The tumors located adjacent to big vessels such as inferior vena cava (IVC), could not be ablated completely sometimes.

Microwave ablation (MWA) can ablate tumor by higher temperature than RFA, so is supposed not to be diminished by adjacent vessels. Several pre-clinical studies have already demonstrated MWA is a safe and effective treatment for live cancers. The system (Solero Microwave Tissue Ablation System) with 2.45 GHz microwave generator could create a spherical ablation zone, and has certificated by CE mark and FDA approval in 2017. However, there are still few experiences in using MWA for tumor ablation in Taiwan. In this study, we will perform MWA for 20 inoperable patients with liver cancers adjacent to IVC in our hospital. The researchers will evaluate the potential side effect and ablate effect of tumors by abdominal CT or MRI, and the researchers will also follow-up this patients for 4 months to evaluate the complete ablation rate and local recurrence rate. We will appraisal the clinical feasibility and advantage of the system by this study.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

the efficacy of microwave ablation for the treatment of primary or secondary liver cancers: modified RECIST criteria

时间窗: up to one year

The primary measure for this will be the evaluation of tumor response according to the modified RECIST criteria by CT or MR imaging performed 1 month after treatment.

次要结局

  • safety and local tumor recurrences(within 30 days of treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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