Endoscopic electroporation in esophageal cancer

Michael Patrick Achiam0 个研究点开始时间: 2016年2月8日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•1.Male or female =18 years old.
•2.Histological verified adenocarcinoma in the gastro-oesophageal junction.
•3.Expected survival > 3 months.
•4.Performance status ECOG/WHO < 2.
•5.Sexually active women who can become pregnant should use adequate contraception during the trial (pill, spiral, injection of prolonged progestin, sub dermal implantation, hormone-containing vaginal devices, transdermal patches).
•6.Platelets = 50 billion/L, International Normalized Ratio (INR) < 1.5. Medical correction is allowed, e.g. correction of a high INR using vitamin K.
•7.Se-creatinine < 150 mole/L, (Cr-51-EDTA-clearance > 40 ml/min) are excluded. (Se-creatinine > 150 mole/L triggers a Cr-51-EDTA-clearence test).
•8.Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
•9.Subjects must give written informed consent.
•10.The patient has a progressing disease, despite previously treatment with palliative chemo/radio therapy
•11.The patient has a progressing disease, despite previously treatment with palliative radio therapy and he/she can not tolerate palliative systemic chemotherapy treatment.
•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 renal dysfunction (Cr-51-EDTA-clearance < 40 ml/min are excluded. If p-creatinine > 150 micromole/L triggers a Cr-51-EDTA-clearence test).
•3.Subjects with a clinically significant cardiac arrhythmia.
•4.Diabetes.
•5.Pregnancy or lactation/breastfeeding.
•6.Concurrent treatment with an investigational medicinal product.
•7.Contraindications for use of bleomycin, including acute pulmonary infection, severe pulmonary disease and allergic reactions to bleomycin observed in previous treatment.
•8.Subjects who have previously undergone a regime of bleomycin with a cumulative dose of > 240.000 units/m2.
•9.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. This includes stenosis that prevents passage of the endoscope.

发起方

Michael Patrick Achiam