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Not yet recruitingNCT06780592Updated Jan 22, 2025

Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

A Phase 2 interventional study of Vebreltinib + Temozolomide and Temozolomide in Glioblastoma, sponsored by Huashan Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Huashan Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to explore the effects of Vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and MET-TKI.

02

Conditions studied

  • Glioblastoma

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Keywords

  • Vebreltinib
  • Temozolomide
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 60 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-65 years, female or male
  2. Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
  3. c-MET overexpression diagnosed by IHC
  4. KPS ≥60

  5. Adequate hematological, renal, and hepatic function.

    All patients should meet the following criteria:

    1. absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
    2. serum creatinine clearance ≥80 mL/min
    3. total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
    4. aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT \< 2.5 × ULN
  6. The patient and his/her family members were informed and provided signed and informed consent

Exclusion criteria

Exclusion Criteria:

  1. Any previous postoperative treatment except for concurrent chemoradiotherapy;
  2. Individuals unable to undergo cranial MRI examination;
  3. Active hemorrhage detected by cranial CT or MRI scan before enrollment;
  4. Uncontrolled hypertension;
  5. Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
  6. Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA >1000IU/ml;
  7. Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
  8. Pregnant or lactating women;
  9. Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
  10. Individuals deemed unsuitable for participation in this clinical trial by the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Vebreltinib + Temozolomide

    Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).

    Drug: Vebreltinib + Temozolomide

  • Active comparator
    Temozolomide

    Participants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).

    Drug: Temozolomide

Interventions

  • DrugVebreltinib + Temozolomide

    Vebreltinib is a capsule in the form of 25 mg and 100mg, twice daily. Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).

  • DrugTemozolomide

    Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    The primary outcome is the PFS of patients, the time from randomization and group allocation to any recorded disease progression, and even death.

    Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.

Secondary outcomes

  1. Overall survival (OS)

    The time from randomization and allocation to death for any reason

    Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.

  2. The Karnof sky Performance status scale (KPS)

    The scale measures the levels of patient activity and medical needs. The score ranges from 100 (no signs of disease) to 0 (dead).

    Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.

  3. Objective response rate (ORR)

    Objective response rate (ORR) = (CR + PR)/total number of cases × 100%. A complete response (CR) is defined as the disappearance of all target lesions. A partial response (PR) is defined as a reduction of at least 30% in the sum of diameters of the target lesions, considering the baseline sum diameters as a reference. The ORR will be determined by MRI according to the Response Evaluation Citeria in Solid Tumors (RECIST)

    Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.

  4. Incidence of adverse events (AEs)

    Adverse events (CTC-Toxicity ≥ grade III) will be recorded and analyzed based on the Common Terminology Criteria for Adverse Events (CTC-AE)

    Time frame: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06780592
Lead sponsor
Huashan Hospital
Collaborators
Beijing Tiantan Hospital, Beijing Sanbo Brain Hospital
Responsible party
Jinsong Wu (Professor, Huashan Hospital) — Principal investigator
First posted
Jan 17, 2025
Start date
Jan 13, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 22, 2025

Study contacts

Jinsong Wu, Professor
Contact
wjsongc@126.com
+86-13701707118

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 Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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