NCT07349693

Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma

A Randomized Trial to Assess the Efficacy and Safety of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Everfront Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Recurrent Glioblastoma, IDH-Wildtype

Interventions

Type	Name	Description
DRUG	Cerebraca wafer	Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)
DRUG	Temozolomide (for relapsed malignant glioma)	TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.

Timeline

• Start date: 2026-11-01
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study