This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.
Male or female patients ≥ 18 years of age at the time of study enrollment.
Body mass index (BMI) ≥ 17 kg/m2.
Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.
Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.
Patients who have radiographic evidence of multifocal enhancing tumors.
Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.
Patients who have previously received Carmustine wafers implantation during re-operation.
Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.
Parallel
Bevacizumab
DrugAn anti-angiogenic agent to block tumor growth
Microbubble
DrugOpen the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble
Low-Intensity Focused Ultrasound
DeviceOpen the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble
6-month progression-free survival (PFS-6) of Bevacizumab (BEV) with or without microbubble-mediated focused ultrasound (FUS-MB) using NaviFUS System
PFS-6 will be estimated the proportion of patients who remain progression-free at the 6-month time point, based on Response Assessment in Neuro-Oncology (RANO) Criteria, from the time of randomization.
12-month progression-free survival (PFS-12)
PFS-12 will be estimated the proportion of patients who remain progression-free at the 12-month time point, based on Response Assessment in Neuro-Oncology (RANO) Criteria, from the time of randomization.
Progression-free survival time (PFS)
PFS is defined as the time from the date of randomization to the earliest date of the first objective documentation of radiographic progression disease based on RANO Criteria, death, or last known follow-up due to any cause whichever occurs first. PFS will be followed continuously till the End-of-Study.
One- and Two-year survival rates
One- and Two-year survival rates will be estimated the proportion of patients who remain alive at the one-year and two-year time points from the time of randomization.
Overall survival (OS)
OS is defined as the time from the date of randomization to the earliest date of death or last known follow-up due to any cause whichever occurs first. OS will be followed continuously while subjects are on study and the survival follow-up phase of the study.
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