Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury (BRAIN)

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Brain Injuries

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05303259

2021-KY-095

Details and patient eligibility

About

To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.

Full description

Radiotherapy-induced brain injury (RI) is a serious complication of radiotherapy in head and neck cancer (HNC) patients. Previous studies have confirmed that Bevacizumab has a good effect on patients with symptomatic RI .However, patients with RI maybe do not show clinical symptoms in the early stage. The clinical symptoms will appear with the progression of the RI lesion. There has been no relevant research on whether early intervention is necessary for asymptomatic RI. The investigators conduct this multicenter, randomized clinical research to explore the efficacy and safety of Bevacizumab in asymptomatic RI.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Head MRI confirmed RI lesions. Sign the informed consent.

Exclusion criteria

With clinical symptoms of RI lesions. Head MRI showed bleeding lesions Contraindications of Bevacizumab. Pregnant women and parturient women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

204 participants in 2 patient groups

HNC patients with radiation-induced brain injury.

Experimental group

Description:

Bevacizumab 2.5mg/kg， q2w，4 cycles.

Treatment:

Drug: Bevacizumab

HNC patients without brain injury after radiotherapy.

No Intervention group

Description:

No treatment.