To investigate the efficacy, safety and tolerability of superselective cerebral arterial infusion of Bevacizumab combined with intrathecal injection of Tislelizumab in the treatment of recurrent glioblastoma
Glioblastoma multiforme (GBM) is a highly malignant intracranial tumor with a median survival of only about 15-17 months after standard treatment. Patients with GBM often experience disease recurrence, and once recurrence occurs, treatment options are very limited, with a median overall survival of only about 6 months. Results of a phase II clinical trial of nivolumab combined with standard or reduced-dose bevacizumab iv therapy for recurrent GBM showed that the median PFS for the two groups was 5.6 months vs. 4.6 months, respectively. The aim of this study is to improve the outcome of recurrent GBM patients by changing the route of administration of the two drugs, such as delivering Bevacizumab via intra-arterial infusion and administering PD-1 monoclonal antibodies via intrathecal injection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Tislelizumab is a drug material authorized for marketing in China. Tislelizumab will be administered off-label in this study. Subjects with recurrent GBM will receive intrathecal tislelizumab every 3 weeks for six times. Intrathecal administration of Bevacizumab will be performed via Ommaya reservoir or intraventricular catheter.
Progression-Free Survival
PFS was defined as the time from random assignment until objective tumor progression (independent image committee assessment) or death (any cause)
Time frame: Up to 10 approximately months
Objective Response Rate
ORR is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set.
Time frame: Up to 10 approximately months
Overall Survival
OS was defined as the time from random assignment until death (any cause) or censored at the last date of known survival.
Time frame: Up to 10 approximately months
Duration of Response
Time from the patient 's first assessment of clinical response to the first assessment of disease progression or death from any cause.
Time frame: Up to 10 approximately months
Safety and Tolerability
The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 10 approximately months after last dose
Time frame: Up to 10 approximately months
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