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?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Immunological outcome
研究概览
简要总结
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
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Immunological outcome
时间窗: 9 months
ELISA
次要结局
- Number of local tumor recurrences(9 months)
- Overall survival(9 months)
- Number of distant tumor recurrences(9 months)
- Cancer specific survival(9 months)
