Clinical trial · Interventional
Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery
The Efficacy of Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery: a Study Protocol for a Prospective, Open-label ,Multi-center, Randomized, Controlled Trial in China
NCT06780592CI-TRIAL-00084976not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
| Vebreltinib + Temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vebreltinib + Temozolomide
- description
- Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).
- interventionNames
- Drug: Vebreltinib + Temozolomide
- type
- ACTIVE_COMPARATOR
- label
- Temozolomide
- description
- Participants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction).
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.