NCT05611645

Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence

A Randomized Phase II Trial of Concurrent Low-dose Bevacizumab and HSRT Versus Bevacizumab Alone for Glioblastoma at First Recurrence: HSCK-005

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.

Detailed description

To establish an improvement in 6-month pfs in recurrent glioblastoma patients receiving low-dose bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.

Conditions

• Glioma
• Recurrent Glioma

Interventions

Type	Name	Description
RADIATION	Hypofractionated Stereotactic Radiotherapy	Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on consecutive treatment days.
DRUG	Bevacizumab	Staring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg (comparison group) every two weeks until disease progression.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-11-10
• Last updated: 2022-11-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study