Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread

Recruiting now · Phase 2

Conditions studied: Glioblastoma (GBM)

In brief

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。

Key facts

Study ID

NCT07193654

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

38

Starts

2025-04-01

Expected to finish

2028-04-01

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 2nd Affiliated Hospital, School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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