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

NCT07758062 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB2026-YX-261-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Glioblastoma; IDH-Wildtype; Hypoxia; Levetiracetam; Stupp Regimen; Temozolomide; Progression-Free Survival; HIF-1α

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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

Secondary Outcomes (1)

• Overall Survival (OS)

  Up to 36 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants receive levetiracetam extended-release granules in combination with the standard Stupp regimen.

Drug: Levetiracetam Extended-Release Granules; Drug: Temozolomide (TMZ); Radiation: Radiotherapy

Control Group

ACTIVE COMPARATOR

Participants receive the standard Stupp regimen alone.

Drug: Temozolomide (TMZ); Radiation: Radiotherapy

Interventions

Levetiracetam Extended-Release Granules DRUG

Oral levetiracetam extended-release granules administered according to the study protocol.

Experimental Group

Temozolomide (TMZ) DRUG

Temozolomide administered according to the standard Stupp regimen.

Control Group; Experimental Group

Radiotherapy RADIATION

Standard external beam radiotherapy administered according to the Stupp regimen.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Glioblastoma; Hypoxia

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Central Study Contacts

Longtao Cui, doctor

CONTACT

19358023216; clt664141691@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be assigned to either the levetiracetam extended-release plus Stupp regimen group or the standard Stupp regimen group according to the study protocol. Outcomes will be compared between the two parallel groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tianjin Medical University General Hospital

Model Details: Participants will be assigned to either the levetiracetam extended-release plus Stupp regimen group or the standard Stupp regimen group according to the study protocol. Outcomes will be compared between the two parallel groups.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)