Endo, Makoto
Kataoka, Tomoko
Fujiwara, Toshifumi
Tsukushi, Satoshi
Takahashi, Masanobu
Kobayashi, Eisuke
Yamada, Yoko
Tanaka, Takaaki
Nezu, Yutaka
Hiraga, Hiroaki
Wasa, Junji
Nagano, Akihito
Nakano, Kenji
Nakayama, Robert
Hamada, Tetsuya
Kawano, Masanori
Torigoe, Tomoaki
Sakamoto, Akio
Asanuma, Kunihiro
Morii, Takeshi
Machida, Ryunosuke
Sekino, Yuta
Fukuda, Haruhiko
Oda, Yoshinao
Ozaki, Toshifumi
Tanaka, Kazuhiro
Funding for this research was provided by:
Japan Agency for Medical Research and Development (JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507, JP21ck0106507)
National Cancer Center Research and Development Fund (2020-J-3, 2020-J-3, 2020-J-3, 2020-J-3)
Article History
Received: 29 December 2022
Accepted: 28 February 2023
First Online: 8 March 2023
Declarations
:
: All patients receive verbal and written information and provide their written informed consent before enrolment. This study is conducted in accordance with the ethical principles stipulated in the “Declaration of Helsinki” (revised October 2013) and “Clinical Trials Act” (announced April 14, 2017, enacted April 1, 2018) established by Japan’s Ministry of Health, Labour, and Welfare. This study was approved by the National Cancer Center Hospital CRB (CRB3180008) on October 3, 2019 (approval number: T2019003).The results of the study will be submitted to international peer-reviewed journals, and the main findings will be presented at international scientific conferences. The authors are attributed according to the guidance of the International Committee of Medical Journal Editors.Any amendments to the protocol will undergo a review by the National Cancer Center Hospital CRB. This study protocol was lately corrected in December 2021 (ver. 1.4.0) due to the minor amendment.
: Not applicable.
: ME receives honoraria from Daiichi Sankyo Co., Ltd., Kyowa Kirin Co., Ltd., Bayer AG, Boehringer Ingelheim International GmbH, Taiho Pharmaceutical Co., Ltd., Novartis AG, and Eisai Co., Ltd. MT receives grants from MSD, Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim International GmbH, and honoraria from Daiichi Sankyo Co., Ltd., Bristol Myers Squibb Company, and Ono Pharmaceutical Co., Ltd. EK receives honoraria from Eisai Co., Ltd. HF receives honoraria from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., CMIC Co., Ltd., and m3, Inc. KT is an advisory board member of Taiho Pharmaceutical Co., Ltd., and receives honoraria from Taiho Pharmaceutical Co., Ltd., Novartis AG, and Eisai Co., Ltd. The other authors declare that they have no conflicts of interest.