FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma

NCT07058428 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-Sen University Cancer Center

Phase

Phase 3

Started

2025-06-30

Last updated

2025-12-02

Condition(s) studied

Multiple Brain Metastases in Lung Adenocarcinoma

Investigational drug(s) / intervention(s)

Bevacizumab →FSRTWhole brain radiotherapy

Bevacizumab: Bevacizumab starts on day 1 (one week before FSRT treatment), q3w，a total of 4 treatment courses, intravenous injection, with a dose of 7.5mg/kg.

FSRT: The FSRT group received simple FSRT radiotherapy; FSRT is targeted at visible intracranial lesions, with a total dose of 30Gy, administered once a day for a total of 5 days, with a fraction dose of 6Gy.

Whole brain radiotherapy: The WBRT group received whole brain radiotherapy and locally increased dose radiotherapy for visible intracranial lesions, with a total dose of 40Gy for local lesions and 25Gy for the whole brain, once a day for a total of 10 days.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years old; * Cellular or histopathological confirmation of lung adenocarcinoma; * Prior to enrollment, brain enhanced magnetic resonance imaging shows (1) 1-2 brain metastases, with at least one measuring ≥3 cm in diameter; or (2) 3-10 brain metastases, with at least one measuring ≥2 cm in diameter; or (3) 11-20 brain metastases; and deemed unsuitable for single-session SRS by radiation oncologists; * At the time of enrollment, the extracranial disease status is stable; * Eastern Cooperative Oncology Group (ECOG) physical fitness status score 0-2 points * Normal liver, kidney, and bone marrow function within 14 days prior to enrollment: peripheral blood white blood cell count ≥ 4 × 10\^9/L; neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 100g/L, serum creatinine\<1.5 times the upper limit of normal values; Bilirubin\<1.5 times the upper limit of normal value; Transaminase\<2 times the upper limit of normal value; * The patient and their family agree and sign an informed consent form. Exclusion Criteria: * There are contraindications for bevacizumab, such as a history of cardiac and/or thromboembolic events, or uncontrolled hypertension; * Meningeal metastasis or extensive intracranial metastasis are not suitable for FSRT; * Bleeding tendency or coagulation dysfunction; * Patients with hemoptysis (≥ 1/2 teaspoon of fresh blood per day) within the past month; * Use full dose anticoagulant therapy within the past month; * Has experienced severe vascular disease in the past 6 months; * Have experienced gastrointestinal fistula, perforation, or abdominal abscess within the past 6 months; * Has experienced hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York Class II or above), acute myocardial infarction, cerebral infarction, cerebral parenchymal hemorrhage, or other active cerebrovascular or cardiovascular diseases within the past 6 months; * Patients with a history of arterial aneurysm or arteriovenous malformation; * Having undergone major surgery within 28 days, or minor surgery or needle biopsy within 48 hours; * Urinary protein 3-4+, or 24-hour urinary protein quantification\>1g; * Simultaneously accompanied by serious and uncontrolled other diseases.

Primary outcome measure(s)

Intracranial progression free survival — 2 years
the time interval from the end of radiotherapy to the first occurrence of intracranial progression or death or the last follow-up;

Trial sites (1)

Facility	City	Region	Status
Sun yat-sen University Cancer Center	Guangzhou	Guangdong	Recruiting

On this site

📄 Avastin (bevacizumab) drug profile →

More Sun Yat-Sen University Cancer Center trials in China

Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma Recruiting

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer Recruiting

Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401) Recruiting

Safety and Efficacy of CAR-T Cell Therapy for Relapsed/refractory Neuroblastoma and Desmoplastic Small Round Cell Tumors: a Single-arm, Open-label Trial. Recruiting

QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07058428 on ClinicalTrials.gov ↗ ← All trials in China