Glioblastoma (GBM)Phase 2NCT07193654
Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread
A Phase 2 study testing Intrathecal injection of thiotepa, Stupp regimen (oral temozolomide) and Radical radiotherapy in people with Glioblastoma (GBM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Intrathecal injection of thiotepa, Stupp regimen (oral temozolomide) and Radical radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Pregnant or breastfeeding women.
- 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.
- Ventricular drainage tube rupture or inability to undergo lumbar puncture.
- Uncontrolled chronic diseases like diabetes, CHF, liver cirrhosis, or CKD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang, 310000
Ting Zhang phD, +86571-87783521, zezht@zju.edu.cn
phD
About this study
Official title: 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。
Read the detailed description
Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, with a dismal prognosis despite standard treatment. The standard treatment for GBM, which includes surgery, radiotherapy, and chemotherapy with temozolomide (known as the Stupp regimen), has remained largely unchanged for over two decades. Patients with GBM who have tumor invasion of the brain ventricles or meningeal metastasis face an even worse prognosis, with significantly shorter progression-free survival and overall survival compared to patients without these complications. The blood-brain barrier poses a significant challenge to effective chemotherapy delivery, limiting the efficacy of systemic treatments for central nervous system tumors. Intrathecal chemotherapy administration represents a promising strategy to overcome this barrier by directly delivering chemotherapeutic agents into the cerebrospinal fluid, potentially improving tumor control and survival outcomes in patients at high risk for intraventricular dissemination.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Intrathecal injection of thiotepa, Stupp regimen (oral temozolomide), Radical radiotherapy, Maximal surgical resection
- Keywords
- brain ventricles invasion, meningeal metastasis, Intrathecal chemotherapy
- Medical subject headings
- Glioblastoma, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal injection of thiotepaDrug
Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.
Stupp regimen (oral temozolomide)Drug
Stupp regimen (oral temozolomide)::75 mg/m² daily during radiotherapy; 150-200 mg/m² daily for 5 days every 28 days for 6 cycles after radiotherapy;
Radical radiotherapyRadiation
Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;
Maximal surgical resectionProcedure or surgery
Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;
| Study group | Role | What they receive |
|---|---|---|
| Stupp plus intrathecal injection of thiotepa | Experimental | Not described Receives: Drug: Intrathecal injection of thiotepa; Drug: Stupp regimen (oral temozolomide); Radiation: Radical radiotherapy; Procedure: Maximal surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Incidence and severity of treatment-related adverse events using CTCAE 5.0.
Measured: From first dose of study treatment until 30 days after last dose, assessed up to 52 weeks.
Secondary outcomes (2)
Progression-free survival
Time from treatment initiation until disease progression( RECIST1.1 )
Measured: 3 months,6 months and 1 year after treatment
Overall survival
Time from treatment initiation until death
Measured: Until date of death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193654
- Sponsor's protocol ID
- Y2025-0127
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07193654
- Acronym / sponsor ID
- Y2025-0127
- Conditions
- Glioblastoma (GBM)
- Keywords
- brain ventricles invasion, meningeal metastasis, Intrathecal chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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。
Detailed description
Glioblastoma (GBM) is the most common and aggressive primary malignant brain tumor in adults, with a dismal prognosis despite standard treatment. The standard treatment for GBM, which includes surgery, radiotherapy, and chemotherapy with temozolomide (known as the Stupp regimen), has remained largely unchanged for over two decades. Patients with GBM who have tumor invasion of the brain ventricles or meningeal metastasis face an even worse prognosis, with significantly shorter progression-free survival and overall survival compared to patients without these complications. The blood-brain barrier poses a significant challenge to effective chemotherapy delivery, limiting the efficacy of systemic treatments for central nervous system tumors. Intrathecal chemotherapy administration represents a promising strategy to overcome this barrier by directly delivering chemotherapeutic agents into the cerebrospinal fluid, potentially improving tumor control and survival outcomes in patients at high risk for intraventricular dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stupp plus intrathecal injection of thiotepa | Experimental | Drug: Intrathecal injection of thiotepa, Drug: Stupp regimen (oral temozolomide), Radiation: Radical radiotherapy, Procedure: Maximal surgical resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal injection of thiotepaIntrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol. | Drug | Stupp plus intrathecal injection of thiotepa |
| Stupp regimen (oral temozolomide)Stupp regimen (oral temozolomide)::75 mg/m² daily during radiotherapy; 150-200 mg/m² daily for 5 days every 28 days for 6 cycles after radiotherapy; | Drug | Stupp plus intrathecal injection of thiotepa |
| Radical radiotherapyRadical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each; | Radiation | Stupp plus intrathecal injection of thiotepa |
| Maximal surgical resectionMaximal surgical resection: Removal of as much tumor as possible while preserving neurological function; | Procedure or surgery | Stupp plus intrathecal injection of thiotepa |
Primary outcome
Safety assessment
Time frame: From first dose of study treatment until 30 days after last dose, assessed up to 52 weeks.
Incidence and severity of treatment-related adverse events using CTCAE 5.0.
2 secondary outcomes
Progression-free survival
Time frame: 3 months,6 months and 1 year after treatment
Overall survival
Time frame: Until date of death from any cause, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrathecal injection of thiotepa, Stupp regimen (oral temozolomide) and Radical radiotherapy in people with Glioblastoma (GBM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhang, phD. (+86-571-87783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (time frame: From first dose of study treatment until 30 days after last dose, assessed up to 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.