A Phase I/Ib trial of Ad-REIC in liver cancer: Study protocol

Astushi Oyama, Hidenori Shiraha, Daisuke Uchida, Masaya Iwamuro, Hironari Kato, Akinobu Takaki, Fusao Ikeda, Hideki Onishi, Tetsuya Yasunaka, Yasuto Takeuchi, Nozomu Wada, Yoshiaki Iwasaki, Masahiro Sakata, Hiroyuki Okada, Hiromi Kumon

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)3547-3554
Number of pages8
JournalFuture Oncology
Volume15
Issue number31
DOIs
Publication statusPublished - Jan 1 2019

Keywords

  • DKK-3
  • gene therapy
  • hepatic cancer
  • liver metastasis
  • pancreatic ductal adenocarcinoma
  • prognosis
  • targeted treatment

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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