This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of low-dose radiotherapy combined with programmed death 1 (PD-1) inhibitor (sintilimab) and temozolomide in recurrent glioblastoma. The eligible patients are scheduled to administered sintilimab 200mg D1 Q3W temozolomide 50mg/m2 QD and radiotherapy 1Gy/1F D1/D2/D8/D15 Q3W for 4-6 cycles, then sintilimab for maintenance. The overall primary study hypothesis is that the combination regimen of low-dose radiotherapy, sintilimab and temozolomide is safe and feasible in the treatment of recurrent glioblastoma.
Histologically confirmed glioblastoma, radiographically or pathologically diagnosed recurrence.
Aged ≥ 18 years.
≥12 weeks after postoperative radiotherapy.
Karnofsky performance status (KPS) ≥ 60.
Treatment with a dose of prednisone > 10mg /d or equivalent dose of corticosteroids is required.
There exist other uncontrolled central nervous system diseases unrelated to cancer.
A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
Uncontrolled cardiac clinical symptoms or diseases, such as New York Heart Association (NYHA) class II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
Single group
Sintilimab
DrugSintilimab 200mg D1, Q3W
Low-dose Radiotherapy
RadiationRadiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W
progression free survival (PFS)
median progression free survival
overall survival (OS)
median overall survival
Adverse events
CTCAE 5.0
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