NCT07841106尚未招募2 期
Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 49
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky performance status (KPS) score ≥
- •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).
- •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.
- •Within 14 days before study treatment, bone marrow and major organ function must meet the following criteria: ANC ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L; total bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; serum creatinine ≤1.5×ULN or CrCl ≥45 mL/min; INR ≤1.5; APTT ≤1.5×ULN; urine protein <2+; if urine protein ≥2+, 24-hour urine protein <2 g.
- •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.
- •Patients voluntarily participate, have signed the written informed consent form (ICF), and are expected to comply with and follow all study requirements.
排除标准
- •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.
- •History of arterial thromboembolic events (e.g., MI, unstable angina, CVA, or TIA) within 6 months before the first dose.
- •Symptomatic CHF (NYHA Class ≥ II) or severe arrhythmia requiring treatment.
- •Severe hepatic/renal insufficiency: total bilirubin >1.5×ULN; or ALT/AST >2.5×ULN; or serum creatinine >1.5×ULN and CrCl <45 mL/min.
- •Urine protein ≥++, or 24-hour urine protein ≥2.0 g.
- •History of gastrointestinal perforation, active gastrointestinal bleeding, intra-abdominal abscess, or active IBD.
- •Symptomatic uncontrolled brain metastasis hemorrhage or obvious intracranial hypertension crisis, as judged by the investigator.
- •Contraindications to MRI.
- •Pregnant or lactating women.
- •Any severe acute/chronic 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.
- •Poor compliance, and the patient is not expected to complete all necessary treatment and follow-up assessments.
研究组 & 干预措施
Cohort A (Early Prophylaxis)
Experimental
Inclusion of 23 subjects.
干预措施: Recombinant Human Endostatin (Endostar) (Drug)
Cohort B (Late Salvage Cohort)
Experimental
Inclusion of 26 subjects.
干预措施: Recombinant Human Endostatin (Endostar) (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From enrollment to death from any cause, assessed up to 60 months.
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.
次要结局
- Change in Quality of Life Score Assessed by the EORTC QLQ-BN20(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(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)(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(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(Baseline and Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days).)
研究者
Lin Xiao
Deputy Director of the Oncology Department
Jiangmen Central Hospital
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