OncoMatch/Clinical Trials/NCT06220552
The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma
Is NCT06220552 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab for recurrent glioblastoma.
Treatment: Sintilimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: radiation therapy — postoperative
≥12 weeks after postoperative radiotherapy
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
Cardiac function
Uncontrolled cardiac clinical symptoms or diseases, such as NYHA class II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention [excluded]
Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test): Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; and platelet count ≥ 100 × 10^9/L; Serum albumin ≥ 28 g/L; Total bilirubin ≤ 1.5 × ULN; Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Activated partial clotting enzyme time and INR ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ). Thyroid stimulating hormone ≤ ULN; If abnormal, T3 and T4 levels should be examined, and if T3 and T4 levels are normal, they can be screened.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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