This study is intend to explore the efficacy and safety of combined treatment of camrelizumab and bevacizumab in adult patients with recurrent glioblastoma.
There is no effective chemotherapy regimen for recurrent glioblastoma. The antiangiogenic drug bevacizumab has high objective response rate and rapid onset, but the duration of efficacy needs to be improved.The objective response rate of PD-1 monoclonal antibody immunotherapy is low and the onset of the effect is slow, but the effective patients have a long duration of efficacy.The combined treatment of PD-1 monoclonal antibody and bevacizumab may learn from each other to improve the effective rate, shorten the onset time and prolong the duration of efficacy.Studies have shown that bevacizumab can enhance the efficacy of immunotherapy in a variety of cancers, including melanoma, kidney cancer, non-small cell lung cancer, and liver cancer.However, previous studies have shown limited efficacy of PD-1 monoclonal antibody combined with bevacizumab in the treatment of recurrent glioblastoma. In this study, the combination therapy was optimized by introducing induction phase therapy, which is expected to further improve the efficacy. In our previous exploratory treatment of patients with severe recurrent glioblastoma after multiple treatments, the initial efficacy was considerable. The purpose of this study is to evaluate the efficacy and safety of camrelizumab \[a programmed cell death 1 (PD-1) inhibitor\] combined with bevacizumab for adult patients with recurrent glioblastoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Stage 1: Targeted therapy induction phase: bevacizumab 5mg/kg, intravenous infusion, once every two weeks, 2 cycles in total. Phase 2: Targeted combined immunotherapy: once every three weeks with the following drugs: (1) bevacizumab 7.5mg/kg intravenously;(2) Carrelizumab: 200mg/ time, intravenous infusion.
Beijing Sanbo Brain Hospital
Beijing, China
Progression-free survival rate at 6 months
Progression-free survival rate at 6 months
Time frame: Up to three years
OS(overall survival)
the time interval from entry to death from any cause or last follow-up and is measured in the intent-to-treat population
Time frame: Up to three years
PFS(progression free survival)
the time interval from entry to tumor progression, death from any cause, or last follow-up
Time frame: Up to three years
ORR(objective response rate)
rate of CR+PR
Time frame: Up to three years
DCR(Disease Control Rate)
rate of CR+PR+SD
Time frame: Up to three years
The correlation between KPS change and efficacy
the correlation between KPS baseline, KPS change (increase, decrease,stable) and best efficacy (CR, PR, SD, PD).
Time frame: Up to three years
Median duration of KPS ≥ 70
Median duration of KPS ≥ 70 during progression-free survival
Time frame: Up to three years
Frequency and severity of treatment-related adverse events
Frequency and severity of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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Time frame: Up to three years
Median duration of stable/improved quality of life assessed by EORTC QLQ-C30
the time interval from entry to change of ≥10 points on the EORTC QLQ-C30 without further improvement or disease progression or death.
Time frame: Up to three years
Median duration of stable/improved quality of life assessed by EORTC QLQ-BN20
the time interval from entry to change of ≥10 points on the EORTC QLQ-BN20 without further improvement or disease progression or death.
Time frame: Up to three years