An interventional study of Tislelizumab and Bevacizumab in Glioblastoma, sponsored by Second Affiliated Hospital of Nanchang University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Treatment
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 36 is close to the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 78 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1, 18 ≤ age ≤ 75 years. 2. Recurrent glioblastoma who failed first-line therapy, with no more than 3 prior episodes of disease progression and at least one confirmed and evaluable lesion.
Exclusion Criteria:
Pregnant or lactating women. 2. Active infection requiring intravenous antibiotics requiring therapeutic anticoagulation with warfarin.
This is a prospective, interventional, multicenter Phase 2 trial for the treatment of patients with recurrent GBM who will receive Bevacizumab arterial infusion combined with Tislelizumab intrathecal injection. The study consists of two parts: the "arterial infusion part" in part 1, where each subject will receive 15 mg/Kg of Bevacizumab by cerebral arterial infusion over 15 minutes at a fixed time (d0, d30, d60); the infusion of 20% mannitol 12.5 ml over 120 seconds prior to the infusion of Bevacizumab; and the "intrathecal injection part" in part 2, where the subject will receive a fixed dose of intrathecal PD1 therapy (Tislelizumab 20 mg, d1, Q3W) intrathecal injection every 3 weeks for 6 cycles.
Drug: Tislelizumab and Bevacizumab
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Nanchang University