Glioblastoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18–70 years; 2.Histologically confirmed glioblastoma; 3.Newly diagnosed patients; 4.Treated via neurosurgical intervention; 5.Expected to commence chemoradiotherapy 4–6 weeks after surgical resection; 6.Postoperative imaging confirms Rapid Early Progression (REP); 7.ECOG performance status 0–1; 8.Anticipated survival of >=3 months; 9.Normal major organ function.
Exclusion criteria
Exclusion criteria: Absolute Exclusion (4.2.1): 1.Severe infection (requiring hospitalization, bacteremia, or severe pneumonia) within 4 weeks prior to enrollment; 2.Known allergy to bevacizumab or humanized antibodies; 3.Active bleeding or hemorrhagic disease; 4.Unhealed postoperative incision, infection, or cerebrospinal fluid (CSF) leak; 5.Inability to undergo MRI or allergy to MRI contrast agents; 6.Allergy to temozolomide; 7.Participation in another clinical trial or use of other investigational drugs within 30 days prior to enrollment. Relative Exclusion (4.2.2): 1.Uncontrolled hypertension (systolic blood pressure >= 150 mmHg or diastolic blood pressure > 90 mmHg); 2.Myocardial infarction or unstable angina within the past 6 months; 3.Congestive heart failure (NYHA Class >= II); 4.Severe arrhythmia (excluding asymptomatic atrial fibrillation); 5.Active Hepatitis B or Hepatitis C (HBsAg+ / HBV DNA >= ULN, or HCV-Ab+ / HCV RNA >= ULN); 6.Use of high-dose aspirin (> 325 mg/day) or antiplatelet agents within 14 days prior to the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate (PFS-6); | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival;Overall Survival (OS);1-year overall survival rate;Objective Response Rate (ORR);Quality of Life Score (Optional); | — |
Countries
China
Contacts
The First Affiliated Hospital of Fujian Medical University