Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 2
Started
2025-04-01
Last updated
2025-09-26
Condition(s) studied
Glioblastoma (GBM)
Investigational drug(s) / intervention(s)
Intrathecal injection of thiotepaStupp regimen (oral temozolomide)Radical radiotherapyMaximal surgical resection
Intrathecal injection of thiotepa: Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.
Stupp regimen (oral temozolomide): Stupp regimen (oral temozolomide)::75 mg/m² daily during radiotherapy; 150-200 mg/m² daily for 5 days every 28 days for 6 cycles after radiotherapy;
Radical radiotherapy: Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;
Maximal surgical resection: Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;
Study summary
The goal of this clinical trial is to learn if a combined treatment approach can treat glioblastoma (GBM) with ventricular invasion or meningeal metastasis in adults. The main questions it aims to answer are:
Does the combined treatment of radical radiotherapy, the Stupp regimen (oral temozolomide), and intrathecal injection of thiotepa improve progression-free survival compared to standard treatment alone?
Does the combined treatment improve overall survival compared to standard treatment alone?
Participants will:
* Undergo maximal surgical resection of the tumor；
* Receive radical radiotherapy；
* Take oral temozolomide according to the Stupp regimen；
* Receive intrathecal injections of thiotepa。
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 18 - 75, any gender.
* Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion, imaging suggesting ventricular or meningeal invasion.
* History of intraoperative intraventricular or cisternal opening.
* Malignant cells found in cerebrospinal fluid pre-radiotherapy.
* ECOG score 0 - 2, expected survival≥3 months.
* Stable neurological symptoms for over 7 days.
* Neutrophil count≥1.5×10⁹/L, hemoglobin≥90 g/L, platelet count≥75×10⁹/L.
* PT/INR and PTT≤1.5×upper limit of normal.
* Total bilirubin≤1.5×upper limit of normal, AST and ALT≤1.5×upper limit of normal, albumin≥30 g/L, creatinine≤2×upper limit of normal, calculated or 24-hour urine creatinine clearance rate≥50 mL/min.
* Agree to effective contraception from first to 3 months after last dose.
Exclusion Criteria:
* Pregnant or breastfeeding women.
* Active infection within 7 days before starting study drug requiring IV antibiotics or therapeutic warfarin.
* Other malignancies in past 5 years.
* HIV/AIDS history; past immunodeficiency, or active autoimmune disease needing systemic treatment.
* Severe medical, neurological, or psychiatric conditions preventing full adherence to study treatment or assessments.
* Ventricular drainage tube rupture or inability to undergo lumbar puncture.
* Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD.
Primary outcome measure(s)
Safety assessment — From first dose of study treatment until 30 days after last dose, assessed up to 52 weeks. Incidence and severity of treatment-related adverse events using CTCAE 5.0.
Trial sites (1)
Facility
City
Region
Status
2nd Affiliated Hospital, School of Medicine
Hangzhou
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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