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OncoMatch/Clinical Trials/NCT07193654

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

Is NCT07193654 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Intrathecal and Stupp regimen (oral temozolomide) for glioblastoma (gbm).

Phase 2RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT07193654Data as of May 2026

Treatment: Intrathecal · Stupp regimen (oral temozolomide)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。

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage WHO GRADE 4 (WHO)

Grade: 4 (WHO)

Newly diagnosed WHO grade 4 brain tumor with at least one evaluable lesion, imaging suggesting ventricular or meningeal invasion

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Lab requirements

Blood counts

Neutrophil count ≥1.5×10⁹/L, hemoglobin ≥90 g/L, platelet count ≥75×10⁹/L, PT/INR and PTT ≤1.5×ULN

Kidney function

creatinine ≤2×ULN, calculated or 24-hour urine creatinine clearance rate ≥50 mL/min

Liver function

Total bilirubin ≤1.5×ULN, AST and ALT ≤1.5×ULN, albumin ≥30 g/L

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.

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