A Phase I/Ib trial of Ad-REIC in liver cancer: study protocol
A Phase I/Ib trial of Ad-REIC in liver cancer: study protocol
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DOI：
10.2217/fon-2019-0115
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发表时间：
2019-11-01
期刊：
影响因子：
3.3
通讯作者：
Kumon, Hiromi
中科院分区：
文献类型：
--
作者：
Oyama, Astushi;Shiraha, Hidenori;Kumon, Hiromi
本研究将评估向肝细胞癌（HCC）或胰腺癌肝转移患者的肝肿瘤给予表达永生化细胞中人降低表达的腺病毒载体（Ad-REIC）的安全性和有效性。将进行向患有HCC或胰腺癌肝转移的患者的肝肿瘤施用Ad-REIC的I期临床研究。本研究是一项在日本冈山的冈山大学医院进行的单臂、前瞻性、非随机、非比较、开放标签、单中心试验。Ad-REIC将在超声引导下注射到肝脏肿瘤中。Ad-REIC给药将每2周重复共3次。主要终点是剂量限制性毒性和不良事件的发生率。次要终点是客观缓解率和疾病控制率。本研究旨在通过评估Ad-REIC在HCC或胰腺癌肝转移患者中的安全性和有效性来扩大Ad-REIC的适应症。
This study will assess the safety and efficacy of the administration of adenoviral vector expressing the human-reduced expression in immortalized cells (Ad-REIC) to a liver tumor in patients with hepatocellular carcinoma (HCC) or liver metastasis of pancreatic cancer. A Phase I clinical study of Ad-REIC administration to a liver tumor in a patient with HCC or liver metastasis of pancreatic cancer will be conducted. The study is a single-arm, prospective, nonrandomized, noncomparative, open-label, single-center trial performed in Okayama University Hospital, Okayama, Japan. Ad-REIC will be injected into the liver tumor under ultrasound guidance. Ad-REIC administration will be repeated a total of three-times every 2 weeks. The primary end point is the dose-limiting toxicity and incidence of adverse events. The secondary end points are the objective response rate and disease control rate. This study aims to expand the indication of Ad-REIC by assessing its safety and efficacy in patients with HCC or liver metastasis of pancreatic cancer.