NCT04553510

Treatment of Bevacizumab Followed by Steroid in RN

Treatment of Bevacizumab Followed by Steroid in Radiation-induceded Brain Injury：a Randomized，Controlled and Single-blind Clinical Trail

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy

Detailed description

Radiation-induced brain injury is a severe complication of radiotherapy in patients with Nasopharyngeal carcinoma. Current neuroprotective therapies show limited benefit in ameliorating this complication of radiotherapy. This study is a randomized, single blind clinical study. The primary aim of this study is to determine whether treatment of bevacizumab followed by steroid can alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma, and to compare the treating effect between combination of bevacizumab and steroid and bevacizumab alone.

Conditions

• Nasopharyngeal Carcinoma
• Adverse Effect of Radiation Therapy
• Brain Injuries

Interventions

Type	Name	Description
DRUG	Bevacizumab and steroid	Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
DRUG	Bevacizumab and placebo	Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2020-09-17
• Last updated: 2020-09-17

Locations

1 site across 1 country: China