PTPRZ1-METFUsion GENe(ZM-FUGEN)trial:study protocol for a multicentric,randomized,open-label phase II/III trial  

作　　者：Zhaoshi Bao Shouwei Li Liang Wang Bisi Zhang Peilong Zhang Hepeng Shi Xiaoguang Qiu Tao Jiang 

机构地区：[1]Department of Neurosurgery,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China [2]Chinese Glioma Genome Atlas Network(CGGA)and Asian Glioma Genome Atlas Network(AGGA),Beijing,China [3]Department of Neurosurgery,Sanbo Brain Hospital,Capital Medical University,Beijing 100093,China [4]Department of Neurosurgery,Tangdu Hospital,Fourth Military Medical University,Xi’an,China [5]Beijing Pearl Biotechnology Limited Liability Company,Beijing,China [6]Department of Radio‑Therapy,Beijing Tiantan Hospital,Capital Medical University,Beijing 100050,China [7]Beijing Neurosurgical Institute,Capital Medical University,Beijing 100070,China [8]Center of Brain Tumor,Beijing Institute for Brain Disorders,Beijing 100069,China [9]China National Clinical Research Center for Neurological Diseases,Beijing 100050,China

出　　处：《Chinese Neurosurgical Journal》2023年第4期315-319,共5页中华神经外科杂志（英文）

基　　金：funded by The National Key Research and Development Program of China(2019YFE0109400);National Natural Science Foundation of China(No.81972337 and No.81802994);Beijing Natural Science Foundation(No.JQ20030);Outstanding Young Talents of the Capital Medical University(No.B2101)

摘　　要：Background PTPRZ1-MET fusion was reported to associate with glioma progression from low-grade to high-grade glioma,which was a target by a MET inhibitor vebreltinib.However,little is known about the further efficacy of vebreltinib among more glioma patients.This trial aims to evaluate the safety and efficacy of vebreltinib enteric-coated capsules in the treatment of sGBM/IDH mutant glioblastoma patients with the ZM fusion gene.Methods This multicentric,randomized,open-label,controlled trial plans to include 19 neurosurgical centers and recruit 84 sGBM or IDH mutant glioblastoma patients with the ZM fusion gene.This trial enrolls sGBM or IDH mutant glioblastoma patients with the inclusion criteria and without the exclusion criteria.It was registered with chinadrugtrials.org.cn(CTR20181664).The primary efficacy endpoint is overall survival(OS).The secondary endpoints are progression-free survival(PFS)and objective response rate(ORR).Discussion If proven effective,this targeted multifaceted intervention protocol will be extended for more glioma patients as a protocol to evaluate the safety and efficacy of MET inhibitors.Trial registration It was registered with chinadrugtrials.org.cn(CTR20181664).

关 键 词：GLIOBLASTOMA IDH mutation PTPRZ1-MET Vebreltinib Phase II/III Clinical trial 

分 类 号：R739.4[医药卫生—肿瘤]