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)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Longtao Cui, doctor
- 電話番号：19358023216
- メール：clt664141691@163.com
研究場所
-
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300052
- Tianjin Medical University General Hospital
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB2026-YX-261-02
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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