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)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Longtao Cui, doctor
- 전화번호: 19358023216
- 이메일: clt664141691@163.com
연구 장소
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300052
- Tianjin Medical University General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-Free Survival (PFS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Survival (OS)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB2026-YX-261-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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