An interventional study of Teniposide Combined with Temozolomide in Newly Diagnosed Glioblastoma and MGMT-Unmethylated Glioblastoma, sponsored by Sun Yat-sen University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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:
Participants will:
Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.
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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
Exclusion Criteria:
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
Drug: Teniposide Combined with Temozolomide
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.
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%.
Time frame: 24 months after completion of treatment for all study participants/subjects
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Mar 2030, 41 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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