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临床试验/NCT02079623
NCT02079623已完成不适用

Implementation of Electroporation - NanoKnife as Treatment for Advanced Pancreatic Cancer.

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Tumor response

研究概览

简要总结

The aim for this study is to implement electroporation therapy (NanoKnife) treatment for patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be given in addition to standard chemotherapy.

详细描述

Pancreatic cancer has a very high mortality with a 5-year survival rate of less than 10 %. Even though pancreatic cancer accounts for only 2-3 % of all cancer cases, it is the 4th leading cause of cancer death. The best prognosis is observed in patients, where tumor is confined to pancreas, and where curative resection is feasible. This accounts for 5-12% of patients. After complete surgical resection, these patients have a median survival of 15-25 months and a 5-year survival rate of 8-15%. Approximately 40% of patients with pancreatic cancer have metastatic disease at time of diagnosis, a significantly worse prognosis with a median survival of 6-12 months and very low long-term survival (less than 1%). The remaining 40-50% of patients have locally advanced disease (LAPC) without metastases. It is not possible to do complete surgical resection of LAPC because the tumor is infiltrating the surrounding tissue or blood vessel. These patients also have a severe prognosis with a poor long-term survival and median survival time of approximately 12 months.

The majority of patients with LAPC are offered palliative chemotherapy as standard treatment. Few patients are offered downstaging with chemo-radiotherapy. In rare cases downstaging results in extensively tumor shrink which enables subsequently surgical resection. However, the majority of patients remain none-resectable and only candidates for palliative/symptomatic treatment.

Electroporation is a new local treatment of tumors. Tumor cells are exposed to series of direct current impulses with high voltage (1500 V / cm) of milliseconds duration. Electroporation was originally used to enhance the sensitivity of tumor cells to certain cytotoxic agents by increasing the permeability of the cell membrane. Later it was found that direct current at sufficiently high voltage can destroy the cell membrane of cancer cells without damaging surrounding connective tissue or blood vessels. By modulating the length of the impulses and voltage, this cell-killing effect is achieved without any significant heating of the tissue, which reduces the risk of thermal damage. Electroporation differs in this way from other forms of local treatment such as radiofrequency ablation (RFA), which acts through the heating and coagulation of tissue.

The aim for this study is to implement electroporation therapy (NanoKnife) treatment for patients with locally advanced pancreatic cancer. Electroporation therapy (NanoKnife) will be given in addition to standard chemotherapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above 18 years old, who have given informed consent to treatment with electroporation
  • Performance status <= 2 and meets one of the items below
  • Patients diagnosed with LAPC, who are not candidate to primary curative surgical treatment due to tumor invasion in surrounding blood vessels or adjacent organs
  • Patients, who have received oncological treatment with the aim of downstaging and the tumor still is deemed none-resectable

排除标准

  • Patients with pacemaker or similar electrostimulator (TNS, anal sphincter stimulators ect.)
  • Patients for whom the anesthesia involves high risk (ASA- IV)
  • Estimated survival of less than 3 months
  • Metallic stent in the biliary tract, which can not be removed or changed to plastic stent.
  • Performance status >
  • Epilepsy or other condition involving convulsions
  • Inability to give informed consent.
  • Patients with inability to cooperate for treatment and follow-up
  • Severe heart disease
  • Patients with a tumor larger than 5 cm.

结局指标

主要结局

Tumor response

时间窗: 24 months follow-up

According to RECIST criteria (PET-CT)

次要结局

  • Overall survival(24 months follow-up)
  • CA-19-9(24 months follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

MD, DMSc, Professor of Surgery

Aalborg University Hospital

研究点 (1)

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