Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Korábbi kezelés

• Any previous postoperative treatment except for concurrent chemoradiotherapy;
• Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
• Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;

Más betegség

• Active hemorrhage detected by cranial CT or MRI scan before enrollment;
• Uncontrolled hypertension;
• Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA >1000IU/ml;

Laborértékek

• Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;

Egyéb

• Individuals unable to undergo cranial MRI examination;
• Pregnant or lactating women;
• Individuals deemed unsuitable for participation in this clinical trial by the investigator.

• 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 and informed consent