Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302.

"Conflict of Interest Statement M.I. reports having received personal fees and others from Bayer, Bristol-Myers Squibb, Eli Lilly, Eisai, and Chugai; personal fees from Sumitomo Dainippon, EA Pharma, and Gilead; other from Takeda Pharmaceutical, AstraZeneca, and Merck Serono during the conduct of this study; in addition, he received personal fees and other from ASLAN, Daiichi Sankyo, Novartis, Kyowa Hakko Kirin, NanoCarrier, Yakult, and Taiho; personal fees from Teijin Pharma, Shire, Nobel pharma, Otsuka, MSD, Mylan, and NIHON SERVIER; other from Baxalta, Ono, and J-Pharma outside the period of this study. Y.A. reports having received personal fees from Guerbet Japan during the conduct of this study and personal fees from Japan Lifeline, Kyorin Pharma, Canon Medical systems, and Fuji Pharma outside the period of this study. In addition, Y.A. has a patent Sumitomo Bakelite with royalties paid. Y.I. reports having received personal fees from Eisai and Guerbet Japan during the conduct of this study. T.T. reports having received personal fees from Eisai and Guerbet Japan during the conduct of this study. S.S. reports having received personal fees from CANON MEDICAL SYSTEMS and Cosmotec Co., Ltd, outside the period of this study. Y.K. reports having received personal fees from Eisai outside the period of this study. H.S. reports having received personal fees from Eisai during the conduct of this study. M.M. reports having received personal fees from Terumo, Daiichi Sankyo, and Boston Scientific outside the period of this study. M. Sone. reports having received personal fees from Guerbet Japan during the conduct of the study and personal fees from Fuji Pharma Co., Ltd, CANON MEDICAL SYSTEMS; other from Dream Medicals outside the period of this study. Other authors have no conflicts of interests to declare in relation to this study. M.I. is an Editorial Board Member of Liver Cancer."

"Funding Sources This study was supported by a grant from 26-A-27/National Cancer Center Research and Development Fund."

"This study, the JIVROSG-1302 PRESIDENT study, was a Japanese multicenter, unblinded, prospective randomized controlled trial of selective DEB-TACE versus selective cTACE with epirubicin in patients with advanced HCC, focused on the local tumor control rate. The aim of this study was to determine whether selective cTACE or selective DEB-TACE might be superior to achieve CR. The primary endpoint was the CR rate at 3 months, assessed according to the modified RECIST criteria by an independent review committee (IRC) []. The secondary endpoints were the CR rate at 1 month, assessed according to the modified RECIST criteria by the IRC, and the frequency/severity of adverse events. The study protocol was approved by the Institutional Review Boards of the National Cancer Center and the participating centers, and the study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice Guidelines. This trial is registered with UMIN-CTR (http://www.umin.ac.jp/ctr/index-j.htm), with the identification number UMIN 000021250 (https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000024439)."