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

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Liver Neoplasms
Liver
Pancreatic Neoplasms
Hepatocellular Carcinoma
Neoplasm Metastasis
Safety
Neoplasms
Japan
Incidence

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A Phase I/Ib trial of Ad-REIC in liver cancer : Study protocol. / Oyama, Astushi; Shiraha, Hidenori; Uchida, Daisuke; Iwamuro, Masaya; Kato, Hironari; Takaki, Akinobu; Ikeda, Fusao; Onishi, Hideki; Yasunaka, Tetsuya; Takeuchi, Yasuto; Wada, Nozomu; Iwasaki, Yoshiaki; Sakata, Masahiro; Okada, Hiroyuki; Kumon, Hiromi.

In: Future Oncology, Vol. 15, No. 31, 01.01.2019, p. 3547-3554.

Research output: Contribution to journalArticle

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AU - Kumon, Hiromi

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