Primary Purpose:To preliminarily evaluate the efficacy and safety of recombinant human endostatin (Endostar) in the early prophylactic cohort (Cohort A) and late salvage cohort (Cohort B) for radiation-induced brain injury after stereotactic radiosurgery (SRS) in patients with non-small cell lung cancer (NSCLC) brain metastases, with a focus on the improvement rate of peritumoral brain edema.Secondary Purpose:To explore the effects of Endostar treatment on neurological function, quality of life, and survival outcomes in patients with NSCLC brain metastases following SRS; and to evaluate the convenience and compliance of the "72-hour continuous intravenous pump infusion" regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Dosage Regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days). Treatment Cycle: Every 3 weeks (21 days) constitutes one cycle, for a total of 4 cycles. Route of Administration: Intravenous infusion (continuous pump infusion). Treatment Timing: Cohort A (early prevention cohort): The first cycle should be initiated within 14 days after stereotactic radiosurgery (SRS). Total Treatment Duration: Approximately 12 weeks (4 cycles, 21 days per cycle).
Dosage regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days). Treatment cycle: One cycle every 3 weeks (21 days), for a total of 4 cycles. Route of administration: Intravenous infusion (continuous pump infusion). Timing of treatment: Cohort B (late salvage cohort): initiate the first cycle of treatment within 14 days after confirmed diagnosis of radiation-induced brain edema/necrosis (usually ≥3 months after SRS). Total duration of treatment: Approximately 12 weeks (4 cycles, 21 days per cycle).
Overall Survival (OS)
Analyzed by the Kaplan-Meier method. OS is defined as the time from enrollment to death from any cause. Surviving patients are censored at last follow-up.
Time frame: From enrollment to death from any cause, assessed up to 60 months.
Change in Quality of Life Score Assessed by the EORTC QLQ-BN20
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Brain Cancer Module (EORTC QLQ-BN20). The QLQ-BN20 contains 20 items, and scores are linearly transformed to a 0-100 scale. Higher scores indicate greater symptom burden/worse outcome. Changes in scores from baseline to post-treatment are analyzed.
Time frame: Baseline and Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days).
Incidence and Severity of Adverse Events
All adverse events are graded and recorded according to NCI CTCAE v5.0. The incidence, severity, and causal relationship to the study drug are summarized.
Time frame: From informed consent form (ICF) signing until 4 weeks after the last dose of study drug; assessed before each treatment cycle (each cycle is XX days), with summary at 4 weeks after the last dose.
Intracranial Progression-Free Survival (iPFS)
Analyzed by the Kaplan-Meier method. Intracranial progression is defined per RANO-BM criteria on contrast-enhanced T1-weighted brain MRI. Imaging assessments are performed every 2-3 months (each treatment cycle is 21 days).
Time frame: From enrollment until the date of first documented intracranial progression per RANO-BM or death from any cause, whichever came first, assessed up to 60 months; imaging assessments every 2-3 months.
Brain edema improvement rate
Edema volume around target lesions is measured on T2/FLAIR sequences of brain MRI at baseline and post-treatment. Brain edema improvement is defined as a ≥25% reduction in edema volume from baseline. The response rate is calculated as: (number of patients with ≥25% reduction in edema volume / total number of evaluable patients) × 100%.
Time frame: At Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days), i.e., the end-of-treatment assessment visit.
Neurological Function Improvement Rate Assessed by Focused Neurological Examination
Neurological function is assessed by focused neurological examination, including cranial nerve, motor, sensory, cerebellar, and reflex evaluations. Improvement is defined as resolution or stabilization of neurological deficits. The improvement rate is calculated as: (number of patients with improvement / total number of evaluable patients) × 100%.
Time frame: Baseline and Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.