Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05303259
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yamei Tang, Ph.D
Principal Investigator Affiliation sun yat-sen memorial hospital,sun yat-sen universicy
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Injuries
Additional Details

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.

Arms & Interventions

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.

Interventions

Drug: - Bevacizumab

Bevacizumab 2.5mg/kg, q2w, 4 cycles.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

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

Status

Recruiting

Address

Sun Yat-Sen Memorial Hospital

Guangzhou, Guangdong, 510120

Site Contact

Yamei Tang, PHD

[email protected]

+86 13556001992

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