胶质瘤
医学
随机对照试验
临床终点
肿瘤科
内科学
胶质母细胞瘤
临床试验
代理终结点
癌症研究
作者
Zhaoshi Bao,Shouwei Li,Liang Wang,Bisi Zhang,Peilong Zhang,Hepeng Shi,Xiaoguang Qiu,Tao Jiang
标识
DOI:10.1186/s41016-023-00329-0
摘要
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.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).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.It was registered with chinadrugtrials.org.cn (CTR20181664).
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