@article{f7ac165362b743bb876d8d6d17d30443,
title = "A Phase I/Ib trial of Ad-REIC in liver cancer: Study protocol",
abstract = "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.",
keywords = "DKK-3, gene therapy, hepatic cancer, liver metastasis, pancreatic ductal adenocarcinoma, prognosis, targeted treatment",
author = "Astushi Oyama and Hidenori Shiraha and Daisuke Uchida and Masaya Iwamuro and Hironari Kato and Akinobu Takaki and Fusao Ikeda and Hideki Onishi and Tetsuya Yasunaka and Yasuto Takeuchi and Nozomu Wada and Yoshiaki Iwasaki and Masahiro Sakata and Hiroyuki Okada and Hiromi Kumon",
note = "Funding Information: The current trial is being conducted by researchers in the Department of Gastroenterology and Hepatology, Okayama University Hospital. The department receives research funding from Momotaro-Gene Co., Ltd, but this fact will not influence the trial results. The funding body had no role in the design of the study and will have no role in the collection, analysis or interpretation of data or in writing the manuscript. Okayama University and Momotaro-Gene Inc., a startup biotech company from the Okayama University, holds the patents of the Ad-REIC agent. They are working together on the development of the Ad-REIC agent as a cancer therapeutic medicine. Okayama University received cGMP-grade products of Ad-SGE-REIC from Momotaro-Gene Inc. to perform the present clinical trial. H Kumon is the Chief Scientific Officer of Momotaro-Gene Inc. He demonstrated the utility of the agent and also own stocks in Momotaro-Gene Inc. Funding Information: The current trial is being conducted by researchers in the Department of Gastroenterology and Hepatology, Okayama University Hospital. The department receives research funding from Momotaro-Gene Co., Ltd, but this fact will not influence the trial results. The funding body had no role in the design of the study and will have no role in the collection, analysis or interpretation of data or in writing the manuscript. Okayama University and Momotaro-Gene Inc., a startup biotech company from the Okayama University, holds the patents of the Ad-REIC agent. They are working together on the development of the Ad-REIC agent as a cancer therapeutic medicine. Okayama University received cGMP-grade products of Ad-SGE-REIC from Momotaro-Gene Inc. to perform the present clinical trial. H Kumon is the Chief Scientific Officer of Momotaro-Gene Inc. He demonstrated the utility of the agent and also own stocks in Momotaro-Gene Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. Publisher Copyright: {\textcopyright} 2019 Future Medicine Ltd.",
year = "2019",
doi = "10.2217/fon-2019-0115",
language = "English",
volume = "15",
pages = "3547--3554",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "31",
}
