Department of Gastroenterology & Hepatology, Okayama University Faculty of Medicine, 2-5-1, Shikata-cho, Okayama 700-8558, Japan.
Department of General Medicine, Okayama University Faculty of Medicine, 2-5-1, Shikata-cho, Okayama 700-8558, Japan.
Future Oncol. 2019 Nov;15(31):3547-3554. doi: 10.2217/fon-2019-0115. Epub 2019 Oct 30.
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.
本研究旨在评估腺病毒载体表达人重组抑制因子（Ad-REIC）在肝癌（HCC）或胰腺癌肝转移患者肝脏肿瘤中的安全性和有效性。将进行一项 Ad-REIC 给药治疗 HCC 或胰腺癌肝转移患者肝脏肿瘤的 I 期临床研究。该研究是一项在日本冈山大学医院进行的单臂、前瞻性、非随机、非对照、开放标签、单中心试验。Ad-REIC 将在超声引导下注入肝脏肿瘤。Ad-REIC 给药将在每 2 周重复总共 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其适应证。
