NCT07193654RecruitingPhase 2
Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
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
Source: ClinicalTrials.gov · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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。
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Glioblastoma
- NCT number
- NCT07193654
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 1 Apr 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active infection within 7 days before starting study drug requiring IV antibiotics or therapeutic warfarin.
Other illness
- 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.
Other
- Pregnant or breastfeeding women.
- Ventricular drainage tube rupture or inability to undergo lumbar puncture.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.