Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05303259
Phase
PHASE2
Status
Unknown

Conditions

  • Brain Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 2.5mg/kg, q2w, 4 cycles.

Study Details

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

Key Dates

First listed
Mar 31, 2022
Start date
Nov 1, 2021
Status verified
Jul 2021
Primary completion
Dec 30, 2024
Completion
Dec 30, 2025

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HNC patients with radiation-induced brain injury.
    Bevacizumab 2.5mg/kg， q2w，4 cycles.
  • No Intervention: HNC patients without brain injury after radiotherapy.
    No treatment.

Primary Outcome Measure

The incidence and duration of onset of clinical symptoms. [ Time Frame: Change form baseline to evaluation at 1 year. ]

Central Contacts

Related Studies