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临床试验/NCT02898649
NCT02898649Unknown不适用

Safety and Efficacy of Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Yonsei University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Safety (frequency of procedure-related complication and death)

研究概览

简要总结

Pancreatic cancer is 5th leading cause of cancer-related death in Korea. It has a dismal prognosis with very low 5-year survival rate, about 5%. Only 10% of pancreatic cancer patients is diagnosed in operable status. So, most of patients could not be treated with curative resection.

Locally advanced pancreatic cancer (LAPC) is defined by defined as surgically unresectable due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but have no evidence of distant metastases. In LAPC patients, systemic chemotherapy with/without radiotherapy was used as a standard therapy, but therapeutic response was very poor. Only less than 30% of patients showed treatment response, and median survival of LAPC patient was only 9 months. Thus, more effective treatment modality is needed for LAPC patients.

Irreversible electroporation (IRE) is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent and hence lethal nanopores in the cell membrane, to disrupt the cellular homeostasis. IRE does not cause thermally induced necrosis and has tissue selectivity, so adjacent tissue or vascular structures can be preserved.

Several clinical trials using IRE were performed to liver, kidney or lung cancer patients. We will operate IRE procedure to LAPC patients who were previously received standard therapy but showed no response, using NanoKnife IRE device. We will investigate treatment response and safety of IRE.

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

入选标准

  • Pathologically confirmed pancreatic cancer patients
  • Locally advanced pancreatic cancer patients. Vascular encasement by tumor was noted in radiological evaluation (CT, MRI or PET-CT)
  • Older than 19 years old and younger than 70 years old
  • Previously treated with systemic chemotherapy or chemoradiotherapy due to locally advanced pancreatic cancer.

排除标准

  • Patients with life-threatening systemic disease.
  • Metastatic or borderline-resectable pancreatic cancer patients
  • Patients with seizure history
  • Patients with arrythmia or heart failure
  • Recent history of myocardial infarction (within 1 year)
  • Patients who have implantable electronic devices. (e.g. pacemaker, defibrillator)
  • Patients who have metal devices (e.g. metal stent) around tumor.
  • Coagulopathy patients.

结局指标

主要结局

Safety (frequency of procedure-related complication and death)

时间窗: from 1 month to 3 month

Safety is evaluated by the frequency of procedure-related complication and death.

Overall survival

时间窗: from 1 month to 3 month

Overall survival is calculated from the date of informed consent acquisition until the date of death.

次要结局

  • Tumor control(within 1 year)
  • Time to progression(within 1 year)
  • Change in CA 19-9(within 1 year)
  • Pain control(within 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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