FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma
Launched by SUN YET-SEN UNIVERSITY CANCER CENTER · Jul 1, 2025
Trial Information
Current as of July 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to treat people with lung cancer that has spread to the brain, specifically when there are multiple brain tumors. The study is testing whether combining a special type of focused radiation treatment called fractionated stereotactic radiotherapy (FSRT) with a medication called bevacizumab can work better and be safer than current treatments. FSRT delivers radiation in several small doses to reduce side effects, which is important for larger or multiple brain tumors. Bevacizumab is a drug that helps improve the effects of radiation by targeting blood vessels in the tumors, which may also reduce swelling and side effects in the brain.
People who might be eligible for this study are adults with lung adenocarcinoma (a common type of lung cancer) that has spread to the brain, with specific sizes and numbers of brain tumors. Their overall cancer outside the brain should be stable, and they need to be in reasonably good health with normal liver, kidney, and blood function. Participants will receive the combined treatment and be closely monitored for how well it controls the brain tumors and any side effects. This study is important because brain tumor growth is a major challenge in lung cancer, and the goal is to find a treatment that helps patients live longer with fewer side effects. If you or a loved one fit these criteria and are interested, you can talk to your doctor about joining this trial.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years old;
- • Cellular or histopathological confirmation of lung adenocarcinoma;
- • Prior to enrollment, brain enhanced magnetic resonance imaging showed (1) 1-2 brain metastases, with at least one diameter ≥ 3cm; or (2) ≥ 3 brain metastases, with at least one diameter ≥ 2cm; or (3) tumors located in or adjacent to the brainstem (distance\<1cm);
- • 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.
About Sun Yet Sen University Cancer Center
Sun Yat-sen University Cancer Center is a leading oncology research and treatment institution in China, affiliated with Sun Yat-sen University. Renowned for its comprehensive cancer care and cutting-edge clinical research, the center focuses on advancing innovative therapies and improving patient outcomes through multidisciplinary collaboration and state-of-the-art technology. It plays a pivotal role in cancer prevention, diagnosis, and treatment, contributing significantly to both national and international oncology research efforts.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported