Papers

Peer-reviewed International journal
Nov, 2019

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

Future Oncol
  • Oyama A
  • Shiraha H
  • Uchida D
  • Iwamuro M
  • Kato H
  • Takaki A
  • Ikeda F
  • Onishi H
  • Yasunaka T
  • Takeuchi Y
  • Wada N
  • Iwasaki Y
  • Sakata M
  • Okada H
  • Kumon H
  • Display all

Volume
15
Number
31
First page
3547
Last page
3554
Language
English
Publishing type
Research paper (scientific journal)
DOI
10.2217/fon-2019-0115

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.

Link information
DOI
https://doi.org/10.2217/fon-2019-0115
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/31663777
ID information
  • DOI : 10.2217/fon-2019-0115
  • ISSN : 1479-6694
  • Pubmed ID : 31663777

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