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.
Karnofsky performance status (KPS) score ≥60.
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Baseline contrast-enhanced brain MRI confirms 1-15 brain metastases, with a total volume of all lesions <15 mL, and the largest lesion with a maximum diameter ≤4.0 cm or volume ≤10 mL.
Cohort A: Planned to receive SRS, and baseline MRI shows significant peritumoral edema (edema index >2), where EI = (tumor volume + edema volume) / tumor volume. Cohort B: Radiographic (MRI) evidence of radiation-induced brain edema/necrosis after SRS (usually ≥3 months after SRS).
Known allergy to Endostar or any of its excipients.
Received any other anti-angiogenic therapy within 4 weeks before the first dose.
Uncontrolled hypertension despite medication (SBP >150 mmHg and/or DBP >100 mmHg).
History of major bleeding (e.g., hemoptysis, gastrointestinal bleeding) or current active bleeding, bleeding tendency, or coagulation disorder.
Parallel
Recombinant Human Endostatin (Endostar)
DrugDosage 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).
Recombinant Human Endostatin (Endostar)
DrugDosage 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.
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.
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.
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).
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%.
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