Stupp Regimen Combined With Intrathecal Injection of Thiotepa for the Treatment of Glioblastoma With Ventricular Invasion or Meningeal Metastasis：a Prospective, Single-Arm, Exploratory Study
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。
• 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.