Tests a combined treatment in adults with advanced glioblastoma brain tumor
Tests surgery, radiotherapy, temozolomide and thiotepa injections in adults with spreading glioblastoma.
Plain-language title generated from the registry record
Registry title: Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed glioblastoma (WHO grade 4 brain tumor) that has spread into the brain's fluid spaces (ventricles) or the membranes around the brain (meninges).
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed WHO grade 4 brain tumor with at least one measurable lesion. Scans suggest spread to the ventricles or meninges. Cancer cells found in the spinal fluid before radiotherapy. The surgeon opened a ventricle or cistern during the operation.
- Biomarker or test result
- Malignant cells in the cerebrospinal fluid before radiotherapy.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Other cancer in the past 5 years
- HIV/AIDS history, past immunodeficiency, or active autoimmune disease needing systemic treatment
- Active infection in the 7 days before starting the study drug that needs IV antibiotics or therapeutic warfarin
- Ventricular drainage tube rupture, or unable to have a lumbar puncture
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07193654, who can take part
Where in China
- 2nd Affiliated Hospital, School of MedicineHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07193654
- Record updated
- 26 September 2025
- Original description
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:Read full original descriptionShow less
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。
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: 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; Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD; Pregnant or breastfeeding women; Ventricular drainage tube rupture or inability to undergo lumbar puncture.