[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657651":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":41,"interventions":52,"overallOfficials":33,"centralContacts":33,"locations":33,"responsibleParty":61,"collaborators":33,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":33,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":33,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":33,"overallStatus":87,"whyStopped":33,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":33},{"fullName":5,"class":6},"Jiangmen Central Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"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.","From enrollment to death from any cause, assessed up to 60 months.",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"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\u002Fworse outcome. Changes in scores from baseline to post-treatment are analyzed.","Baseline and Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days).",{"measure":19,"description":20,"timeFrame":21},"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.","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.",{"measure":23,"description":24,"timeFrame":25},"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).","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.",{"measure":27,"description":28,"timeFrame":29},"Brain edema improvement rate","Edema volume around target lesions is measured on T2\u002FFLAIR 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 \u002F total number of evaluable patients) × 100%.","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.",{"measure":31,"description":32,"timeFrame":17},"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 \u002F total number of evaluable patients) × 100%.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NON_RANDOMIZED","PARALLEL","This study plans to enroll a total of 49 subjects, with 23 assigned to Cohort A (early prevention cohort) and 26 to Cohort B (late salvage cohort).","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Cohort A (Early Prophylaxis)","EXPERIMENTAL","Inclusion of 23 subjects.",[47],"Drug: Recombinant Human Endostatin (Endostar)",{"label":49,"type":44,"description":50,"interventionNames":51},"Cohort B (Late Salvage Cohort)","Inclusion of 26 subjects.",[47],[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":33},"DRUG","Recombinant Human Endostatin (Endostar)","Dosage Regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days).\n\nTreatment Cycle: Every 3 weeks (21 days) constitutes one cycle, for a total of 4 cycles.\n\nRoute 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).\n\nTotal Treatment Duration: Approximately 12 weeks (4 cycles, 21 days per cycle).",[43],{"type":54,"name":55,"description":59,"armGroupLabels":60,"otherNames":33},"Dosage regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days).\n\nTreatment 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\u002Fnecrosis (usually ≥3 months after SRS).\n\nTotal duration of treatment: Approximately 12 weeks (4 cycles, 21 days per cycle).",[49],{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Lin Xiao","Deputy Director of the Oncology Department","100657651","phase-2-early-prophylactic-versus-late-salvage-recombinant-human-endostatin-in-managing-radiosurgery-induced-brain-injury-for-nsclc-brain-metastases-100657651",false,"NCT07841106","Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases","Inclusion Criteria\n\n1. Karnofsky performance status (KPS) score ≥60.\n2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\n3. Baseline contrast-enhanced brain MRI confirms 1-15 brain metastases, with a total volume of all lesions \\\u003C15 mL, and the largest lesion with a maximum diameter ≤4.0 cm or volume ≤10 mL.\n4. Cohort A: Planned to receive SRS, and baseline MRI shows significant peritumoral edema (edema index \\>2), where EI = (tumor volume + edema volume) \u002F tumor volume. Cohort B: Radiographic (MRI) evidence of radiation-induced brain edema\u002Fnecrosis after SRS (usually ≥3 months after SRS).\n5. Prior or concurrent radiotherapy for extracranial lesions is allowed. Prior TKI, chemotherapy, or immunotherapy is allowed. After enrollment, systemic therapy may be continued or adjusted according to clinical need.\n6. Within 14 days before study treatment, bone marrow and major organ function must meet the following criteria: ANC ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL; total bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; serum creatinine ≤1.5×ULN or CrCl ≥45 mL\u002Fmin; INR ≤1.5; APTT ≤1.5×ULN; urine protein \\\u003C2+; if urine protein ≥2+, 24-hour urine protein \\\u003C2 g.\n7. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment. All patients of reproductive potential must agree to use highly effective contraception during the study and for 6 months after the last dose.\n8. Patients voluntarily participate, have signed the written informed consent form (ICF), and are expected to comply with and follow all study requirements.\n\nExclusion Criteria\n\n1. Known allergy to Endostar or any of its excipients.\n2. Received any other anti-angiogenic therapy within 4 weeks before the first dose.\n3. Uncontrolled hypertension despite medication (SBP \\>150 mmHg and\u002For DBP \\>100 mmHg).\n4. History of major bleeding (e.g., hemoptysis, gastrointestinal bleeding) or current active bleeding, bleeding tendency, or coagulation disorder.\n5. History of arterial thromboembolic events (e.g., MI, unstable angina, CVA, or TIA) within 6 months before the first dose.\n6. Symptomatic CHF (NYHA Class ≥ II) or severe arrhythmia requiring treatment.\n7. Severe hepatic\u002Frenal insufficiency: total bilirubin \\>1.5×ULN; or ALT\u002FAST \\>2.5×ULN; or serum creatinine \\>1.5×ULN and CrCl \\\u003C45 mL\u002Fmin.\n8. Urine protein ≥++, or 24-hour urine protein ≥2.0 g.\n9. History of gastrointestinal perforation, active gastrointestinal bleeding, intra-abdominal abscess, or active IBD.\n10. Symptomatic uncontrolled brain metastasis hemorrhage or obvious intracranial hypertension crisis, as judged by the investigator.\n11. Contraindications to MRI.\n12. Pregnant or lactating women.\n13. Any severe acute\u002Fchronic medical condition, psychiatric disorder, or laboratory abnormality that may increase risk, interfere with results, or affect the investigator's judgment of the patient's ability to complete the study.\n14. Poor compliance, and the patient is not expected to complete all necessary treatment and follow-up assessments.","ALL","18 Years","75 Years",{"count":75,"type":76},49,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","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.",[82,83,84,85,86],"Lung Cancer (Non-Small Cell)","Radiation","Brain Injury","Brain Edema","Brain Necrosis","NOT_YET_RECRUITING","2026-09-28",{"date":90,"type":91},"2026-10-01","ACTUAL",{"date":93,"type":76},"2026-09-01",{"date":95,"type":76},"2028-04-30",{"name":5,"class":6}]