Endoscopic assisted Calcium electroporation in esophageal cancer – a safety study

Michael Patrick0 个研究点目标入组 8 人开始时间: 2020年12月10日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•1.Male or female =18 years old.
•2.Histological verified malignant tumor in the esophagus, including the GEJ.
•3.Subjects must have been evaluated by an MDT and been considered unsuitable for potential curative treatment.
•4.Locally progressive disease, and other standard oncological treatment have been considered.
•5.Performance status ECOG/WHO < 2.
•6.Expected survival > 3 months.
•7.Platelets = 50 billion/l, International Normalized Ratio (INR) < 1,5 (medical correction is allowed, e.g. correction of a high INR using vitamin K).
•8.Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
•9.Women of childbearing potential (WOCBP) and male partners to WOCBP should use adequate contraception during the trial (pill, spiral, injection of prolonged progestin, sub dermal implantation, hormone-containing vaginal devices, transdermal patches, condom).
•10.Subjects must give written informed consent
•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 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1.Coagulation disorder that cannot be corrected.
•2.Subjects with a clinically significant cardiac arrhythmia.
•3.Pregnancy or lactation.
•4.Concurrent treatment with another investigational medicinal product.
•5.Stenosis that prevents passage of the endoscope with the device attached.
•6.Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements

发起方

Michael Patrick