Everfront Biotech Co., Ltd.
This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition
Inclusion Criteria, subjects must meet all following criteria for study enrollment: 1. Subject must be aged ≥ 18, regardless of gender 2. Subject must have histologically confirmed glioblastoma with: 1. Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide/radiation) 2. Current presentation being first or second recurrence only 3. Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria 4. Subject must be deemed e…
Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)
TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.
Arctuva estimate
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