A Multicenter Prospective Cohort Study Evaluating Levetiracetam Extended-Release in Combination With Stupp Protocol for IDH-Wildtype Glioblastoma (ELITE)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
Glioblastoma remains one of the most aggressive primary brain tumors, with limited survival despite current standard treatment. Increasing evidence suggests that tumor hypoxia contributes to therapeutic resistance and poor prognosis. Levetiracetam has demonstrated potential antitumor activity in addition to its established role as an antiepileptic agent and may enhance the efficacy of temozolomide in patients with glioblastoma.
This is a multicenter, prospective, open-label, controlled investigator-initiated study designed to evaluate the efficacy and safety of levetiracetam extended-release combined with the Stupp regimen in patients with newly diagnosed hypoxic IDH-wildtype glioblastoma.
Approximately 140 eligible participants will be enrolled from multiple centers in China. Participants will receive either levetiracetam extended-release combined with the standard Stupp regimen or the standard Stupp regimen alone according to the study protocol. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, disease control rate, safety, quality of life, and exploratory biomarker analyses. Participants will be followed according to the protocol until completion of the study.
The study is expected to provide clinical evidence regarding whether levetiracetam extended-release can improve outcomes in patients with hypoxic IDH-wildtype glioblastoma without compromising safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants will be assigned to either the levetiracetam extended-release plus Stupp regimen group or the standard Stupp regimen group according to the study protocol. Outcomes will be compared between the two parallel groups.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <70 years. Histopathologically confirmed primary IDH-wildtype glioblastoma (WHO CNS Grade 4, 2021 WHO Classification).
- •Tumor with hypoxic features confirmed by immunohistochemistry (HIF-1α and CA9 expression score ≥2).
- •Planned to receive standard Stupp protocol after maximal safe surgical resection.
- •Karnofsky Performance Status (KPS) ≥
- •Adequate bone marrow function:
- •Hemoglobin ≥90 g/L Platelet count ≥100 × 10⁹/L White blood cell count ≥3.0 × 10⁹/L Absolute neutrophil count ≥1.5 × 10⁹/L
- •Adequate hepatic function:
- •AST and ALT ≤2.5 × upper limit of normal (ULN) Total bilirubin <50 μmol/L.
- •Adequate renal function:
- •Serum creatinine ≤1.5 × ULN Creatinine clearance (CrCl) ≥36 mL/min. No previous chemotherapy, radiotherapy, immunotherapy, or targeted therapy for glioblastoma.
- •No history of epilepsy or prior antiepileptic drug treatment. Ability to understand the study procedures and provide written informed consent.
- •Willing and able to comply with study procedures and follow-up.
排除标准
- •Known hypersensitivity to levetiracetam, pyrrolidone derivatives, or any study drug component.
- •History of epilepsy or previous treatment with antiepileptic drugs. Requirement for concomitant use of other antiepileptic drugs during the study. Presence of another active malignancy. Severe cardiac, hepatic, renal, hematologic, or other uncontrolled systemic diseases.
- •Uncontrolled metabolic disorders or severe infections. Active hepatitis B, hepatitis C, HIV infection, active syphilis, or active tuberculosis.
- •Participation in another interventional clinical trial within 4 weeks before screening.
- •History of organ transplantation or hematopoietic stem cell transplantation. Pregnancy or breastfeeding, or plans for pregnancy during the study period. Psychiatric illness, cognitive impairment, or poor compliance that would interfere with study participation.
- •Any other condition that, in the investigator's judgment, would make participation unsafe or interfere with study evaluation.
研究组 & 干预措施
Control Group
Participants receive the standard Stupp regimen alone.
干预措施: Temozolomide (TMZ) (Drug)
Experimental Group
Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.
干预措施: Levetiracetam Extended-Release Granules (Drug)
Experimental Group
Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.
干预措施: Radiotherapy (Radiation)
Control Group
Participants receive the standard Stupp regimen alone.
干预措施: Radiotherapy (Radiation)
Experimental Group
Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 24 months
Progression-free survival, defined as the time from study enrollment to disease progression or death from any cause, whichever occurs first.
次要结局
- Overall Survival (OS)(Up to 36 months)
研究者
Chunsheng Kang
Tianjin Medical University General Hospital
Tianjin Medical University General Hospital