Status:
RECRUITING
Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Glioblastoma (GBM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ans...
Detailed Description
Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, with a dismal prognosis despite standard treatment. The standard treatment for GBM, which includes surgery...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07193654
Start Date
April 1 2025
End Date
April 1 2028
Last Update
September 26 2025
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, China, 310000