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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

IntrathecalStupp regimen (oral temozolomide)

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)

Demographics

Ages ≤ 75

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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07193654 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage WHO GRADE 4 is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Glioblastoma trials