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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Beijing Sanbo Brain Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vebreltinib + Temozolomide | Experimental | Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction). |
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| Temozolomide | Active Comparator | Participants received Temozolomide (150 mg/m2) treatment, every 4 weeks for up to 6 cycles (Induction). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebreltinib + Temozolomide | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from randomization and allocation to death for any reason | Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up. |
| The Karnof sky Performance status scale (KPS) |
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Inclusion Criteria:
Aged 18-65 years, female or male
Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
c-MET overexpression diagnosed by IHC
KPS ≥60
Adequate hematological, renal, and hepatic function.
All patients should meet the following criteria:
The patient and his/her family members were informed and provided signed and informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsong Wu, Professor | Contact | +86-13701707118 | wjsongc@126.com |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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This is a prospective, multi-center, randomized, open-label, clinical trial in China.
The plan is to recruit 60 eligible subjects and assign them to either the control group (standard TMZ 5/28 therapy) or the experimental group (TMZ plus LEV Vebreltinib) at a 1:1 ratio. Participants will undergo a 48-week treatment period and a 2-year follow-up period.. The study is expected to commence recruitment in mainland China in about Aug 2024. It is expected that the trial will end in December 2025.
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| Temozolomide | Drug | Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction). |
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The scale measures the levels of patient activity and medical needs. The score ranges from 100 (no signs of disease) to 0 (dead). |
| Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up. |
| 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) | Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up. |
| 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) | Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |