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Standardization of Multi-modal Tumor Ablation Therapy System (SMTATS)

2017年7月17日 更新者:Shanghai Zhongshan Hospital

A Pilot Study of Multi-mode Precision Ablation System for the Treatment of Liver Malignant

This study will document for the safety and efficacy of image guided multi-mode precision ablation system (the combination of cryoablation and radiofrequency ablation) for the treatment of liver malignant, as well as provide the indicator of antitumor immune response for liver malignant in China.

研究概览

详细说明

Either Cryoablation or Radiofrequency Ablation has been well accepted and widely used in clinical practice for solid tumor treatments with various commercial systems. Previous studies have established that locally exerting great thermal and mechanical stress through alternating freezing and heating abruptly broke the tumor cells and micro-vasculature in situ, enabling complete damage of primary tumor. Large amount of biological stimuli was released during this process to enhance body anti-tumor immunological response. This method thus may inhibit distal metastases and increase the survival rate. The investigators hypothesized that multi-mode thermal method (the combination of cryoablation, radiofrequency ablation) might trigger a whole body anti-tumor immune response for malignant tumor basing on multi-scale bio-thermal responses at molecular, cellular, tumor angiogenesis and tissue levels. The purpose of this study was to prospectively investigate the safety and feasibility of multi-mode precision ablation system for the treatment of liver malignant.

研究类型

介入性

注册 (预期的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200032
        • 招聘中
        • Fudan University Shanghai Cancer Center
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 1.Adults aged 18 years to 70 years of either gender;
  • 2. Histologically/cytologically confirmed hepatocellular carcinoma or colorectal cancer with liver metastasis, the primary lesion had underwent radical resection and without local recurrent, extrahepatic metastasis;
  • 3. At least one measurable liver metastasis by RECIST criteria. No more than 5 lesions and smaller than 4.0 cm each;
  • 4. Patients' liver function classified as Child-Pugh A or B, total bilirubin <=3.0 mg/dL, serum creatinine <= 2.5 mg/dL, White blood cell count >= 2.0×10^9/L, Platelets >= 100×10^9/L;
  • 5. Performance Status(PS): Eastern cooperative Oncology Group (ECOG) <= 2, and life expectancy longer than three months;
  • 6. Prior therapy, e.g., chemotherapy, radiation, is allowed provided that more than one month washout time is given, and recover from the previous treatment: according to the Common Terminology Criteria Adverse Events (CTC AE) version 4.0, all side effects (except for hair loss) degrading to 1 level or lower.

Exclusion Criteria:

  • 1. Child-Pugh grade Class C, or tumor invasion into the portal vein;
  • 2. Patient underwent previous cryoablation or other thermal ablation;
  • 3. Patient underwent prior therapy, e.g., chemotherapy, radiation,or other anti-cancer medication no more than 3 weeks;
  • 4. Patients with severe disorders of heart, lung, liver, kidney function or irreversible coagulation disorder;
  • 5. Patients combined with other uncontrolled disease, including but not limited to: hypertension or diabetes, active infection, or mental illness or social condition that may affect the subject's compliance;
  • 6. Pregnant or lactating women.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Multi-modal Precision Ablation
In Multi-modal Precision Ablation group, patients received cryoablation immediately followed by radiofrequency ablation
In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation
其他名称:
  • 冷冻消融
  • 射频消融

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Local control rate
大体时间:From date of randomization until the date of progression of ablation lesion, assessed up to 5 years.
Contrast enhanced CT or MRI was performed to evaluate Local tumor control
From date of randomization until the date of progression of ablation lesion, assessed up to 5 years.

次要结果测量

结果测量
措施说明
大体时间
Overall survival (OS)
大体时间:From date of randomization until the date of death, assessed up to 5 years.
Overall survival is defined as the time (in months) from the date of randomization to the death date.
From date of randomization until the date of death, assessed up to 5 years.
Progression free survival (PFS)
大体时间:From date of randomization until the date of first documented progression, recurrence or date of death from any cause, whichever came first first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Progression-free survival is defined as the time (in months) from the date of randomization until the date of the Investigator-assessed radiological disease progression or death due to any cause.
From date of randomization until the date of first documented progression, recurrence or date of death from any cause, whichever came first first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Complication rate
大体时间:6 months
Number of participants with adverse events and complication
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Lisaxu Xu, MD. PhD.、Shanghai Jiao Tong University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2017年7月1日

初级完成 (预期的)

2019年12月1日

研究完成 (预期的)

2020年7月1日

研究注册日期

首次提交

2017年7月17日

首先提交符合 QC 标准的

2017年7月17日

首次发布 (实际的)

2017年7月21日

研究记录更新

最后更新发布 (实际的)

2017年7月21日

上次提交的符合 QC 标准的更新

2017年7月17日

最后验证

2016年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1604159-3-1605&1604159-3-1606

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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