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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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).
Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
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.
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.
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.
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.
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.
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