Imai, Hiroo
Sakamoto, Yasuhiro
Takahashi, Shin
Shibata, Hiroyuki
Sato, Atsushi
Otsuka, Kazunori
Amagai, Kenji
Takahashi, Masanobu
Yamaguchi, Takuhiro
Ishioka, Chikashi
Article History
Received: 20 June 2023
Accepted: 6 February 2024
First Online: 24 February 2024
Declarations
:
: The trial will be conducted in accordance with the principles of the Declaration of Helsinki and approved by Tohoku Certified Review Board of Tohoku University (approved number: 2022–6-085, approval date: January 31, 2023). The trial is registered with the Japan Registry of Clinical Trials (jRCT; registry number: jRCTs021230005). Informed consent from each patient will be obtained by the principal investigator or co-investigators using an informed consent document. After obtaining written informed consent from the subjects, the principal investigator or co-investigator will confirm that the research participants meet all inclusion criteria.An Efficacy and Safety Monitoring Committee will be formed to determine the need to continue the trial if severe AEs associated with the treatment protocol occur.The results of this trial will be submitted to international peer-reviewed journals, and the main findings will be presented at international scientific conferences. Authorship is assigned according to the guidelines of the International Committee of Medical Journal Editors.
: Not applicable.
: Chikashi Ishioka received a research funding from Tokyo Cooperative Oncology Group. Chikashi Ishioka also received contributions from Chugai Pharmaceutical; Novartis Pharma K.K.; Ono Pharmaceutical; MSD; Pfizer; AstraZeneca; Bristol-Myers Squibb; Kyowa Kirin Co., Ltd.; Janssen Pharmaceutical; Taiho Pharmaceutical; Daiichi Sankyo Company, Ltd.; Takeda Pharmaceutical; Merck Biopharma Co., Ltd.; Eli Lilly Japan K. K.; Bayer Yakuhin, Ltd.; and Incyte Biosciences Japan G.K. Chikashi Ishioka is a representative of the Tohoku Clinical Oncology Research and Education Society, a specified nonprofit corporation. Takuhiro Yamaguchi was a member of an endowed course established at the University of Tokyo and received income from the operating expenses of the endowed course until 2022. Donors for the endowed course included Nipro, Ltd. The other authors declare that they have no conflicts of interest.