NCT07058428 FSRT Combines With Bevacizumab for Multiple Brain Metastases in Lung Adenocarcinoma
| NCT ID | NCT07058428 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-Sen University Cancer Center |
| Condition | Multiple Brain Metastases in Lung Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 258 participants in total. It began in 2025-06-30 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07058428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Brain Metastases in Lung Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07058428 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 258 participants.
Is NCT07058428 currently recruiting?
Yes, NCT07058428 is actively recruiting participants. Contact the research team at liuhui@sysucc.org.cn for enrollment information.
Where is the NCT07058428 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07058428 clinical trial?
NCT07058428 is sponsored by Sun Yat-Sen University Cancer Center. The trial plans to enroll 258 participants.