EUCTR2020-004536-22-DK进行中（未招募）1 期
A phase II Study of Electroporation Potentiated Immunotherapy in Liver Metastatic Pancreatic Cancer - Electroporation Potentiated Immunotherapy in Cancer - 1st study (EPIC-1)
Ole Thorlacius-Ussing0 个研究点目标入组 16 人开始时间: 2020年10月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histologically verified pancreatic adenocarcinoma, based on either a biopsy of the primary tumor or a metastasis
- •2.One liver metastasis treatable by IRE (as determined by MDT at Aalborg University Hospital)
- •3.One tumor lesion suited for repeated biopsy by transcutaneous core needle (preferably another lesion than that used for IRE)
- •4.At least one measurable lesion (RECIST version 1.1) other than the liver metastasis to be treated by IRE
- •5.At least one course of chemotherapy for metastatic or inoperable disease discontinued due to treatment failure or intolerance
- •6.Performance status 0-1
- •7.ASA = 3
- •8.= 18 years of age
- •9.Written and orally informed consent
- •10.Sufficient available histological tumor material stored in biobank or obtainable by new biopsy
- •11.Patient acceptance of collection of blood samples for translational research and two additional biopsies during treatment
- •12.Adequate bone marrow function, liver function, and renal function (within 7 days prior to enrollment):
- •a.Neutrophils (ANC) = 1.5 x 109/l
- •b.Platelet count = 100 x 109/l
- •c.Hemoglobin = 6 mmol/l
- •d.Plasma bilirubin = 1.5 x ULN
- •e.Plasma alanine transaminase (ALAT) < 5 x ULN
- •f.Plasma creatinine = 1.5 x ULN
- •g.INR = 1.5
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1.Underlying medical disease not adequately treated (e.g. poorly regulated diabetes and symptomatic cardiac disease)
- •2.Prior or current autoimmune disorder with risk of serious toxicity during treatment with checkpoint inhibitor
- •3.Acute myocardial infarction, cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months from start of treatment
- •4.Previous reception of allogeneic stem cells or solid organ donation
- •5.Active infection requiring systemic therapy within 7 days prior to treatment initiation
- •6.Positive HIV, HBV, and HCV test results (prior testing or new testing in patients at risk)
- •7.Active psychiatric disease or history of drug or alcohol abuse affecting participation
- •8.Allergy to active substance or any of the auxiliary agents, including known severe allergy to anesthetic agent, paralytic agent or any of the equipment used during treatment
- •9.Expected need for systemic corticosteroid or other systemic immunosuppressive drug during the course of this clinical trial. A low dose of e.g. prednisone = 10 mg/day is permitted for maximally 7 consecutive days
- •10.Coexisting malignant disease, except non-melanoma skin cancer
- •11.Symptomatic or untreated CNS metastases
- •12.Liver cirrhosis Child Pugh >A
- •13.Pregnant or breast-feeding patients. For women of childbearing potential, a negative pregnancy test at screening is mandatory
- •14.Women of childbearing potential not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment. Male patients with a fertile partner are also required to secure effective methods of contraception
- •15.Previous immunotherapy
- •16.Patients referred from a hospital outside of Denmark
- •17.Major dilation of veins or bowel obstructing the needle path
- •18.Persistent atrial fibrillation
- •19.Metal objects (e.g. biliary SEMS) within 5 cm of ablation target
- •20.Cardiac pacemaker or ICD, that cannot be safely disconnected during IRE treatment
研究者
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