Phase
Condition
Gliomas
Astrocytoma
Treatment
Vebreltinib + Temozolomide
Temozolomide
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
serum creatinine clearance ≥80 mL/min
total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT < 2.5 × ULN
The patient and his/her family members were informed and provided signed andinformed consent
Exclusion
Exclusion Criteria:
Any previous postoperative treatment except for concurrent chemoradiotherapy;
Individuals unable to undergo cranial MRI examination;
Active hemorrhage detected by cranial CT or MRI scan before enrollment;
Uncontrolled hypertension;
Decompensated heart failure, unstable angina pectoris, acute myocardial infarction,or persistent and clinically significant arrhythmias within 3 months beforeenrollment;
Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA >1000IU/ml;
Individuals requiring long-term continuous use of hematopoietic growth factors orplatelet transfusions;
Pregnant or lactating women;
Individuals who have received other clinical trial drugs within 30 days before thefirst dose of the study drug;
Individuals deemed unsuitable for participation in this clinical trial by theinvestigator.