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Immune Response After Pancreatic Cancer Treatment (IRE Immuno)

2020年2月25日 更新者:University Hospital Inselspital, Berne

Differential Immunologic Signature After Pancreatic Cancer Treatment: Does Irreversible Electroporation Lead to a Prolonged and Potent T-cell Mediated Immune Response Compared to Surgical Resection?

The aim of this project is to describe the differential immunologic responses of patients who undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor, and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces a long and sustained activation of the cell-mediated immune system, which is distinct from the immune response after surgical resection only. The primary endpoint of this study is the comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary outcome, additional measurements will be taken to more specifically characterize the immune response based on peripheral blood samples. Flow cytometry will be used to quantify cell subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for the primary outcome. Each group of patients as described above will consist of 10 consecutive pancreatic cancer patients. Patients aged 18 or older with resectable, borderline resectable, or locally advanced pancreatic cancer will be included. Patients with locally advanced disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease. Main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.

研究概览

地位

终止

条件

研究类型

观察性的

注册 (实际的)

38

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

      • Bern、瑞士
        • Inselhospital

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 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients undergoing an established procedure for pancreatic cancer. The assignment into either group will be independent of this research proposal and rely completely on clinical judgment. Main outcomes will be changes in immunological short-term and long-term outcomes.

描述

Inclusion Criteria:

  • Age ≥ 18 years
  • Able to undergo general anesthesia (ASA ≤ 4)
  • Performance status ECOG <=2 (Eastern Cooperative Oncology Group)
  • Life expectancy of at least 6 months
  • Resectable, borderline resectable, or locally advanced pancreatic cancer
  • Patients who have locally advanced disease have to show no tumor progression after 3 month of neo-adjuvant chemotherapy+/-XRT before undergoing in situ IRE

Exclusion Criteria:

  • Cardiac AV conduction abnormalities, ventricular fibrillation
  • History of epilepsy
  • Recent history of myocardial infarction (2 months)
  • Evidence of distant metastasis (e.g. liver, lung, peritoneum)
  • Informed consent cannot be given by the patient
  • Known hypersensitivity to the IRE electrodes (stainless steel 304L)
  • Women of childbearing potential who are pregnant, breast feeding, or not taking an adequate method of contraception at the time of procedure

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

队列和干预

团体/队列
干预/治疗
10 IRE locally advanced
patients undergoing in situ IRE for locally advanced pancreatic
Irreversible electroporation is an emerging, mainly non-thermal ablative modality. It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.
10 IRE borderline resection
patients undergoing margin accentuation IRE for borderline resectable disease
Irreversible electroporation is an emerging, mainly non-thermal ablative modality. It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.
10 resection only
patients undergoing surgical resection only

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
Immunological outcome
大体时间:42 days
flowcytometry
42 days
Immunological outcome
大体时间:6 months
Flowcytometry
6 months
Immunological outcome
大体时间:9 months
Flowcytometry
9 months
Immunological outcome
大体时间:42 days
ELISA
42 days
Immunological outcome
大体时间:6 months
ELISA
6 months
Immunological outcome
大体时间:9 months
ELISA
9 months

次要结果测量

结果测量
措施说明
大体时间
Number of local tumor recurrences
大体时间:42 days
measured via CT
42 days
Number of local tumor recurrences
大体时间:3 months
measured via CT
3 months
Number of local tumor recurrences
大体时间:6 months
measured via CT
6 months
Number of local tumor recurrences
大体时间:9 months
measured via CT
9 months
Number of distant tumor recurrences
大体时间:42 days
measured via CT
42 days
Number of distant tumor recurrences
大体时间:3 months
measured via CT
3 months
Number of distant tumor recurrences
大体时间:6 months
measured via CT
6 months
Number of distant tumor recurrences
大体时间:9 months
measured via CT
9 months
Overall survival
大体时间:42 days
survival of patient
42 days
Overall survival
大体时间:3 months
survival of patient
3 months
Overall survival
大体时间:6 months
survival of patient
6 months
Overall survival
大体时间:9 months
survival of patient
9 months
Cancer specific survival
大体时间:42 days
survival of patient
42 days
Cancer specific survival
大体时间:3 months
survival of patient
3 months
Cancer specific survival
大体时间:6 months
survival of patient
6 months
Cancer specific survival
大体时间:9 months
survival of patient
9 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

  • 首席研究员:Mathias Worni, MD、Inselspital Berne

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 (实际的)

2017年2月15日

初级完成 (实际的)

2020年2月25日

研究完成 (实际的)

2020年2月25日

研究注册日期

首次提交

2016年12月20日

首先提交符合 QC 标准的

2017年3月2日

首次发布 (实际的)

2017年3月3日

研究记录更新

最后更新发布 (实际的)

2020年2月26日

上次提交的符合 QC 标准的更新

2020年2月25日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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