タムラ　マナブ   TAMURA Manabu   田村　学    所属   医学研究科 医学研究科 (医学部医学科をご参照ください)    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	A randomized, placebo-controlled phase III trial of an autologous, formalin-fixed tumor vaccine for newly diagnosed glioblastoma: trial protocol
掲載誌名	正式名：Japanese Journal of Clinical Oncology 略　 称：Jpn. J. Clin. Oncol. ISSNコード：03682811/14653621
掲載区分	国外
出版社	オックスフォード大学出版局
巻・号・頁	(hyaf078),pp.e1-e7
著者・共著者	MURAGAKI Yoshihiro†, ISHIKAWA Eiichi , TAMURA Manabu, KAWAMATA Takakazu, GOSHO Masahiko, HASHIMOTO Koichi , KOMORI Takashi, YOKOO Hideaki, MATSUTANI Masao, MAEBAYASHI Katsuya , TANAKA Toshihide, YAMAGUCHI Shigeru , KANAMORI Masayuki , YAMAMOTO Tetsuya, HANIHARA Mitsuto , ARAKAWA Yoshiki , SASAYAMA Takashi , ABE Tatsuya, NAKAMURA Hideo , MUKASA Akitake , UZUKA Takeo, NAKAJO Kosuke , OHNO Tadao
発行年月	2025/05/16
概要	This multi-institutional, double-blind, randomized, placebo-controlled phase III trial was designed to evaluate the efficacy and safety of Cellm-001, an autologous formalin-fixed brain tumor immunostimulant, for newly diagnosed glioblastoma with gross total resection to prolong overall survival (OS) and prevent recurrence after surgery. One hundred twelve patients are to be randomized 1:1 to either Cellm-001 with standard chemoradiotherapy (CRT) or saline solution with standard CRT. Randomization is based on the following stratified randomization criteria: age, Karnofsky Performance Status, and the presence or absence of photodynamic therapy (PDT). The primary endpoint is OS and secondary outcomes are progression-free survival (PFS), OS and PFS with and without radiographically residual lesions as subgroups, OS and PFS with and without PDT, p53-negative OS and PFS, high Cluster of Differentiation-8 score OS and PFS, OS associated with death in primary disease, and 24-month OS and PFS rates. All institutions received ethical committee approval and patient enrollment began in 2021.
DOI	10.1093/jjco/hyaf078