ClinicalTrials.gg
Not yet recruitingNCT07894549Updated Oct 26, 2026

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

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

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Newly Diagnosed Glioblastoma
  • MGMT-Unmethylated Glioblastoma
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    Drug: Teniposide Combined with Temozolomide

Interventions

  • DrugTeniposide 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Oct 2026
Primary completionEst.
Mar 2030
CompletionEst.
Dec 2030
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07894549
Responsible party
Yonggao Mou (Chief Physician, Sun Yat-sen University) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Mar 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 26, 2026

Study contacts

yonggao mou
Contact
mouyg@sysucc.org.cn
86+13808816691

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion