---
title: Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury
nct_id: NCT05303259
overall_status: UNKNOWN
phase: PHASE2
sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
study_type: INTERVENTIONAL
primary_condition: Brain Injuries
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05303259.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05303259"
ct_last_update_post_date: 2022-03-31
last_seen_at: "2026-05-12T06:12:11.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

**Official Title:** Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury in Patients With Head and Neck Cancer

**NCT ID:** [NCT05303259](https://clinicaltrials.gov/study/NCT05303259)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 204
- **Lead Sponsor:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- **Conditions:** Brain Injuries
- **Start Date:** 2021-11-01
- **Completion Date:** 2025-12-30
- **CT.gov Last Update:** 2022-03-31

## Brief Summary

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

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **HNC patients with radiation-induced brain injury.** (EXPERIMENTAL) — Bevacizumab 2.5mg/kg， q2w，4 cycles.
- **HNC patients without brain injury after radiotherapy.** (NO_INTERVENTION) — No treatment.

## Interventions

- **Bevacizumab** (DRUG) — Bevacizumab 2.5mg/kg, q2w, 4 cycles.

## Primary Outcomes

- **The incidence and duration of onset of clinical symptoms.** _(time frame: Change form baseline to evaluation at 1 year.)_ — The incidence and duration of onset of clinical symptoms within 1 year after treatment between the treatment group and the control group.

## Secondary Outcomes

- **change of RI volume.** _(time frame: Change form baseline to evaluation at 1 year.)_
- **change of cognitive function.** _(time frame: Change form baseline to evaluation at 1 year.)_
- **overall survival** _(time frame: Change form baseline to evaluation at 1 year.)_
- **change of quality of life.** _(time frame: Change form baseline to evaluation at 1 year.)_

## Locations (1)

- Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sun yat-sen memorial hospital|guangzhou|guangdong|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05303259*  
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