Glioblastoma (GBM) is the most common primary malignant brain tumor in adults and is associated with poor prognosis despite standard treatment with maximal safe resection followed by radiotherapy plus temozolomide (the Stupp regimen). Tumor hypoxia is associated with treatment resistance and poor clinical outcomes. This multicenter, prospective, controlled study aims to evaluate whether levetiracetam extended-release combined with the Stupp regimen improves progression-free survival and overall survival in patients with hypoxic IDH-wildtype glioblastoma while maintaining an acceptable safety profile. Eligible patients with newly diagnosed hypoxic IDH-wildtype glioblastoma will receive either levetiracetam extended-release plus the Stupp regimen or the standard Stupp regimen. Clinical efficacy, safety, and quality-of-life outcomes will be evaluated during follow-up.
Age ≥18 and <70 years. Histopathologically confirmed primary IDH-wildtype glioblastoma (WHO CNS Grade 4, 2021 WHO Classification).
Known hypersensitivity to levetiracetam, pyrrolidone derivatives, or any study drug component.
Parallel
Levetiracetam Extended-Release Granules
DrugOral levetiracetam extended-release granules administered according to the study protocol.
Temozolomide (TMZ)
DrugTemozolomide administered according to the standard Stupp regimen.
Radiotherapy
RadiationStandard external beam radiotherapy administered according to the Stupp regimen.
Progression-Free Survival (PFS)
Progression-free survival, defined as the time from study enrollment to disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
Overall survival, defined as the time from study enrollment to death from any cause.
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