Actively Recruiting
FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma
Led by Sun Yat-Sen University Cancer Center · Updated on 2025-12-02
258
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For non-small cell lung cancer brain metastases, stereotactic radiotherapy is gradually replacing whole brain radiotherapy as the standard treatment. When patients have multiple brain metastases or larger tumors (diameter\>2cm), single session stereotactic radiotherapy (SRS) may cause significant neurological damage, so fractionated stereotactic radiotherapy (FSRT) is often used. The recent objective remission rate of FSRT is about 50%, and the 1-year intracranial control rate is about 45%, but intracranial progression remains the main factor affecting long-term survival of patients. Bevacizumab is a recombinant humanized monoclonal antibody against vascular endothelial growth factor, which can improve the efficacy of cranial radiotherapy by normalizing neovascularization and improving the hypoxic state of tumor cells. In addition, bevacizumab can improve the abnormal permeability of neovascularization, reduce exudation and extracellular brain edema, thereby further alleviating the toxic side effects associated with brain radiotherapy. Based on this, this prospective, controlled phase III study will explore the efficacy and safety of the combined use of fractionated stereotactic radiotherapy and bevacizumab in multiple brain metastases of lung adenocarcinoma.
CONDITIONS
Official Title
FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of lung adenocarcinoma by cellular or histopathological testing
- Brain MRI showing either 1-2 brain metastases with at least one ≥3 cm, 3-10 brain metastases with at least one ≥2 cm, or 11-20 brain metastases
- Determined unsuitable for single-session stereotactic radiotherapy by radiation oncologists
- Stable extracranial disease status at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Normal liver, kidney, and bone marrow function within 14 days before enrollment, including specific blood counts and organ function tests
- Patient and family provide informed consent
You will not qualify if you...
- Contraindications to bevacizumab such as history of cardiac or thromboembolic events or uncontrolled hypertension
- Presence of meningeal metastasis or extensive intracranial metastasis unsuitable for FSRT
- Bleeding tendency or coagulation dysfunction
- Hemoptysis of half a teaspoon or more of fresh blood daily within the past month
- Full-dose anticoagulant therapy within the past month
- Severe vascular disease in the past 6 months
- Gastrointestinal fistula, perforation, or abdominal abscess in the past 6 months
- Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (NYHA class II or above), acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or other active cerebrovascular or cardiovascular diseases within the past 6 months
- History of arterial aneurysm or arteriovenous malformation
- Major surgery within 28 days or minor surgery/needle biopsy within 48 hours
- Urinary protein 3-4+ or 24-hour urinary protein over 1 gram
- Serious uncontrolled other diseases present
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Hui Liu
CONTACT
Q
Qiu Bo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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