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Levetiracetam Extended-Release Plus Stupp Protocol for Hypoxic IDH-Wildtype Glioblastoma (ELITE)

6. august 2026 oppdatert av: Chunsheng Kang, Tianjin Medical University General Hospital

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

140

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300052
        • Tianjin Medical University General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental Group
Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.
Legemiddel: Levetiracetam Extended-Release Granules
Oral levetiracetam extended-release granules administered according to the study protocol.
Legemiddel: Temozolomide (TMZ)
Temozolomide administered according to the standard Stupp regimen.
Stråling: Radiotherapy
Standard external beam radiotherapy administered according to the Stupp regimen.
Aktiv komparator: Control Group
Participants receive the standard Stupp regimen alone.
Legemiddel: Temozolomide (TMZ)
Temozolomide administered according to the standard Stupp regimen.
Stråling: Radiotherapy
Standard external beam radiotherapy administered according to the Stupp regimen.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: 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.
Up to 24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Up to 36 months
Overall survival, defined as the time from study enrollment to death from any cause.
Up to 36 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tianjin Medical University General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

6. august 2026

Først innsendt som oppfylte QC-kriteriene

6. august 2026

Først lagt ut (Faktiske)

11. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB2026-YX-261-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared due to institutional policy and participant privacy considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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