Newly Diagnosed GlioblastomaNCT07894549
A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region Unmethylated
A study testing Teniposide Combined with Temozolomide in people with Newly Diagnosed Glioblastoma and MGMT-Unmethylated Glioblastoma, run by Sun Yat-sen University.
Trial summary
The Primary Objective of this study is to evaluate the efficacy and safety of teniposide in combination with temozolomide for the treatment of newly diagnosed glioblastoma (nGBM) with MGMT promotor region unmethylated. The study will also assess the safety of teniposide combined with temozolomide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Glioblastoma, MGMT-Unmethylated Glioblastoma
- What is being tested?
- Teniposide Combined with Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2030
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Newly diagnosed with glioblastoma (nGBM), histopathologically confirmed according to the 2021 WHO Classification of Tumors of the Central Nervous System.
- 2. Aged ≥18 years, regardless of gender. 3. Recovered from maximal cytoreductive surgery; patients with gross total resection, partial resection, or biopsy only are all acceptable.
- 4. Previously received standard concurrent chemoradiotherapy with temozolomide (TMZ), having completed standard adjuvant radiotherapy of approximately 60 Gy (or biologically equivalent dose) with daily TMZ chemotherapy at 75 mg/m².
- 5. About to enter the adjuvant TMZ maintenance therapy phase. 6. Confirmed MGMT promoter methylation-negative (MGMT-unmethylated) status, as determined by central laboratory analysis at each participating site.
- 7. At least 4 weeks (≥28 days) have elapsed since the completion of radiotherapy prior to enrollment.
- 8. Karnofsky Performance Status (KPS) score ≥70, and Eastern Cooperative Oncology Group (ECOG) performance sta
Who cannot join
- 1. Early progressive disease following the completion of TMZ/RT (including patients with suspected pseudoprogression).
- 2. Patients with a history of other malignancies (excluding those who have achieved complete remission from cancer and have not received any disease-related treatment for more than 3 years); patients who have previously received brain radiotherapy, chemotherapy, or immunotherapy; or patients who are currently undergoing or planning to undergo other anti-tumor therapies.
- 3. Baseline MRI indicating a recent risk of intracranial hemorrhage or brain herniation.
- 4. Unresolved toxicity reactions of CTCAE 5.0 grade ≥2 caused by any prior treatment, excluding alopecia.
- 5. Inability to take oral medications or inability to swallow. 6. Presence of any severe and/or uncontrolled diseases, including: (1) Patients with poorly controlled blood pressure despite the use of one antihypertensive medication (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); pat
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The Primary Objective of this study is to evaluate the efficacy and safety of teniposide in combination with temozolomide for the treatment of newly diagnosed glioblastoma (nGBM) with MGMT promotor region unmethylated.
The study will also assess the safety of teniposide combined with temozolomide. The primary questions to be addressed include:
Read more
- Does the treatment demonstrate efficacy for the disease under study?
- What medical problems or adverse events may participants experience while receiving the study drugs?
Participants will:
- Receive teniposide: 60 mg/m² in 500 mL of normal saline, administered as an intravenous infusion over at least 30 minutes, once daily on Days 1-3 of each cycle. Each cycle is 28 days, for a total of 6 cycles.Receive temozolomide (TMZ) orally: 150 mg/m² once daily for 5 days during Cycle 1; starting from Cycle 2, the dose will be increased to 200 mg/m² once daily for 5 days. Each cycle is 28 days, for a total of 6 cycles.
- Visit the hospital for assessments at each cycle.
- Have their medication adherence and assessment results recorded.
- Being tested
- Teniposide Combined with Temozolomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teniposide Combined with TemozolomideDrug
Receive teniposide: 60 mg/m² in 500 mL of normal saline, administered as an intravenous infusion over at least 30 minutes, once daily on Days 1-3 of each cycle. Each cycle is 28 days, for a total of 6 cycles.
Receive temozolomide (TMZ) orally: 150 mg/m² once daily for 5 days during Cycle 1; starting from Cycle 2, the dose will be increased to 200 mg/m² once daily for 5 days. Each cycle is 28 days, for a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Drug: Teniposide Combined with Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall Survival
Median overall survival (mOS) is defined as the time at which half of the cases are still alive, which is the time estimated when the survival rate on the OS survival curve reaches 50%.
Measured: 24 months after completion of treatment for all study participants/subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed GlioblastomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonggao Mou, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894549
- Sponsor's protocol ID
- 2026-FXY-018-神经外科
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multicenter Clinical Study of Teniposide Combined With Temozolomide for the Treatment of Newly Diagnosed Glioblastoma (nGBM) With MGMT Promotor Region Unmethylated
- ClinicalTrials.gov ID
- NCT07894549
- Acronym / sponsor ID
- 2026-FXY-018-神经外科
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Oct 2026 (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 Primary Objective of this study is to evaluate the efficacy and safety of teniposide in combination with temozolomide for the treatment of newly diagnosed glioblastoma (nGBM) with MGMT promotor region unmethylated.
The study will also assess the safety of teniposide combined with temozolomide. The primary questions to be addressed include:
- Does the treatment demonstrate efficacy for the disease under study?
- What medical problems or adverse events may participants experience while receiving the study drugs?
Participants will:
- Receive teniposide: 60 mg/m² in 500 mL of normal saline, administered as an intravenous infusion over at least 30 minutes, once daily on Days 1-3 of each cycle. Each cycle is 28 days, for a total of 6 cycles.Receive temozolomide (TMZ) orally: 150 mg/m² once daily for 5 days during Cycle 1; starting from Cycle 2, the dose will be increased to 200 mg/m² once daily for 5 days. Each cycle is 28 days, for a total of 6 cycles.
- Visit the hospital for assessments at each cycle.
- Have their medication adherence and assessment results recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Teniposide Combined with Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Newly diagnosed with glioblastoma (nGBM), histopathologically confirmed according to the 2021 WHO Classification of Tumors of the Central Nervous System.
- 2. Aged ≥18 years, regardless of gender. 3. Recovered from maximal cytoreductive surgery; patients with gross total resection, partial resection, or biopsy only are all acceptable.
- 4. Previously received standard concurrent chemoradiotherapy with temozolomide (TMZ), having completed standard adjuvant radiotherapy of approximately 60 Gy (or biologically equivalent dose) with daily TMZ chemotherapy at 75 mg/m².
- 5. About to enter the adjuvant TMZ maintenance therapy phase. 6. Confirmed MGMT promoter methylation-negative (MGMT-unmethylated) status, as determined by central laboratory analysis at each participating site.
- 7. At least 4 weeks (≥28 days) have elapsed since the completion of radiotherapy prior to enrollment.
Key exclusion criteria (5 listed)
- 1. Early progressive disease following the completion of TMZ/RT (including patients with suspected pseudoprogression).
- 2. Patients with a history of other malignancies (excluding those who have achieved complete remission from cancer and have not received any disease-related treatment for more than 3 years); patients who have previously received brain radiotherapy, chemotherapy, or immunotherapy; or patients who are currently undergoing or planning to undergo other anti-tumor therapies.
- 3. Baseline MRI indicating a recent risk of intracranial hemorrhage or brain herniation.
- 4. Unresolved toxicity reactions of CTCAE 5.0 grade ≥2 caused by any prior treatment, excluding alopecia.
- 5. Inability to take oral medications or inability to swallow. 6. Presence of any severe and/or uncontrolled diseases, including: (1) Patients with poorly controlled blood pressure despite the use of one antihypertensive medication (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg); pat
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 |
|---|---|---|
| Teniposide Combined with TemozolomideReceive teniposide: 60 mg/m² in 500 mL of normal saline, administered as an intravenous infusion over at least 30 minutes, once daily on Days 1-3 of each cycle. Each cycle is 28 days, for a total of 6 cycles. Receive temozolomide (TMZ) orally: 150 mg/m² once daily for 5 days during Cycle 1; starting from Cycle 2, the dose will be increased to 200 mg/m² once daily for 5 days. Each cycle is 28 days, for a total of 6 cycles. | Drug | Experimental Arm |
Primary outcome
Median Overall Survival
Time frame: 24 months after completion of treatment for all study participants/subjects
Median overall survival (mOS) is defined as the time at which half of the cases are still alive, which is the time estimated when the survival rate on the OS survival curve reaches 50%.
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Teniposide Combined with Temozolomide in people with Newly Diagnosed Glioblastoma and MGMT-Unmethylated Glioblastoma, run by Sun Yat-sen University.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 yonggao mou (86+13808816691, mouyg@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Overall Survival (time frame: 24 months after completion of treatment for all study participants/subjects). 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 Oct 2026.