Phase II study of liposomal irinotecan in combination with cisplatin and bevacizumab for high-grade recurrent glioma.

Abstract

e14059 Background: For patients with high-grade glioma, the most common and aggressive primary brain tumor in adults, disease progression following first-line therapy—maximal safe resection, radiotherapy, and temozolomide—is nearly universal. Treatment options at recurrence remain limited and heterogeneous. This Phase II study evaluated the clinical efficacy of liposomal irinotecan combined with cisplatin and bevacizumab in patients with recurrent high-grade glioma. Methods: Eligible patients were aged 18–75 years with confirmed recurrent high-grade glioma and an ECOG performance status of 0–2. Patients received a regimen of liposomal irinotecan plus bevacizumab every two weeks, combined with cisplatin every four weeks, until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS). Results: From 2024 to 2025, 15 patients were enrolled (13 male, 2 female), with a median age of 54 years (range 32–63). The primary endpoint of median PFS has not yet been reached. Among 8 evaluable patients, the ORR was 75.0% (6/8). Grade ≥3 adverse events occurred in 40% (6/15) of patients and included leukopenia (13.3%), thrombocytopenia (6.7%), neutropenia (13.3%), and diarrhea (26.7%). Conclusions: The combination of liposomal irinotecan, cisplatin, and bevacizumab shows promising activity and manageable toxicity in recurrent high-grade glioma, offering new hope for this difficult-to-treat population. This clinical trial is ongoing and more data will be disclosed in the future. Clinical trial information: ChiCTR2500099331.