Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma (ELITE)
A Multicenter Prospective Cohort Study Evaluating Levetiracetam Extended-Release in Combination With Stupp Protocol for IDH-Wildtype Glioblastoma (ELITE)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Longtao Cui, doctor
- Telefoonnummer: 19358023216
- E-mail: clt664141691@163.com
Studie Locaties
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300052
- Tianjin Medical University General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- 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 Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Experimental Group
Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.
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Oral levetiracetam extended-release granules administered according to the study protocol.
Temozolomide administered according to the standard Stupp regimen.
Standard external beam radiotherapy administered according to the Stupp regimen.
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Actieve vergelijker: Control Group
Participants receive the standard Stupp regimen alone.
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Temozolomide administered according to the standard Stupp regimen.
Standard external beam radiotherapy administered according to the Stupp regimen.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Progression-Free Survival (PFS)
Tijdsspanne: Up to 24 months
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Progression-free survival, defined as the time from study enrollment to disease progression or death from any cause, whichever occurs first.
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Up to 24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Survival (OS)
Tijdsspanne: Up to 36 months
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Overall survival, defined as the time from study enrollment to death from any cause.
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Up to 36 months
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Neoplasmata per histologisch type
- Neoplasmata, glandulair en epitheel
- Tekenen en symptomen, ademhaling
- Astrocytoom
- Glioom
- Neoplasmata, neuro-epitheliaal
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Glioblastoom
- Hypoxie
- Organische chemicaliën
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Therapeutica
- Azoles
- Dacarbazine
- Triazenen
- Imidazolen
- Temozolomide
- Radiotherapie
Andere studie-ID-nummers
- IRB2026-YX-261-02
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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