Levetiracetam extended-release added to standard treatment for hypoxic IDH-wildtype glioblastoma
Tests levetiracetam with standard treatment in adults with newly diagnosed hypoxic glioblastoma.
Plain-language title generated from the registry record
Registry title: Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT07758062, who can take part
Where in China
- Tianjin Medical University General HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University General Hospital
- Trial code
- NCT07758062
- Record updated
- 11 August 2026
- Original description
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.Read full original descriptionShow less
A Multicenter Prospective Cohort Study Evaluating Levetiracetam Extended-Release in Combination With Stupp Protocol for IDH-Wildtype Glioblastoma (ELITE)
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.
Inclusion: 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) ≥70; 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.
Exclusion: 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.