Phase Ib/II Study of Intra-Arterial Isolation Chemotherapy for Locally Advanced Unresectable Pancreatic Adenocarcinoma

Professor Rodney J Lane0 个研究点目标入组 6 人开始时间: 2014年5月1日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1) Patient age = 18 years;
•2) Patient must be competent to give consent for treatment, be informed of the possible risks and benefits of the trial, and provide written informed consent to participate;
•3) Patient must be fit to undergo surgery for implantation/explantation of the AVAS;
•4) Patient must be fit for repeated general anaesthesia as required by the treatment protocol;
•5) Histologically proven adenocarcinoma of the pancreas;
•6) Pancreatic adenocarcinoma stage confirmed as locally advanced unresectable by pancreatic protocol computed tomography and staging laparoscopy;
•7) World Health Organisation (WHO) / Eastern Cooperative Oncology Group (ECOG) score = 2
•8) Adequate bone marrow function;
•9) Adequate renal function;
•10) Adequate liver function;

•1) Metastatic disease;
•2) Previous chemotherapy, radiotherapy, or surgery for pancreatic adenocarcinoma;
•3) Evidence of prognostically significant ascites;
•4) Evidence of pancreatitis;
•5) Patient anatomy incompatible with vascular isolation procedure according to CT-angiography findings;
•6) All pancreatic lesions are not measurable (RECIST v1.1) by CT scan during patient screening;
•7) Allergy to interventional radiology contrast agents;
•8) Allergy or hypersensitivity to chemotherapeutic agents used in study treatment;
•9) Patients who are enrolled or intend to participate in another clinical trial for treatment of pancreatic adenocarcinoma concurrent with this study;
•10) Significant co-morbidities (i.e. life expectancy = 3 months)
•11) Co-morbidities or medical conditions that preclude treatment according to the study protocol without unacceptable risk to patient, or preclude testing according to the study protocol;

发起方

Professor Rodney J Lane