TAMURA Manabu    Department   Graduate School of Medical Science, Graduate School of Medical Science    Position   Associate Professor
Article types	Original article
Language	English
Peer review	Peer reviewed
Title	A randomized, placebo-controlled phase III trial of an autologous, formalin-fixed tumor vaccine for newly diagnosed glioblastoma: trial protocol
Journal	Formal name：Japanese Journal of Clinical Oncology Abbreviation：Jpn. J. Clin. Oncol. ISSN code：03682811/14653621
Domestic / Foregin	Foregin
Publisher	オックスフォード大学出版局
Volume, Issue, Page	55(8),pp.975-981
Author and coauthor	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
Authorship	Corresponding author
Publication date	2025/05/16
Summary	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
PMID	40377260