NCT06127329尚未招募不适用
Efficacy and Safety of Bronchial Infusion Chemotherapy Combined With Drug-loaded Microsphere Embolization of EqualSpheres in the Treatment of Advanced Non-small Cell Lung Cancer
Gang Wu1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This is a prospective, single-arm, open-label study designed to evaluate the efficacy and safety of bronchial infusion chemotherapy（BAI） combined with drug-loaded microsphere embolization of EqualSpheres in advanced Non-small cell lung cancer (NSCLC). Progression-free survival (PFS) will be evaluated as the primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old, male and female;
- •According to the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 edition), the patient was diagnosed with NSCLC by imaging and histopathology;
- •TNM stages were III-IV;
- •Newly diagnosed, first-line treatment failure, refusal or inability to perform conventional treatment (surgery, chemoradiotherapy);
- •ECOG PS ≤2;
- •Expected survival > 3 months;
- •Sign the informed consent voluntarily, and the compliance is good.
排除标准
- •Previously received interventional therapy (iodine particle implantation, ablation, TACE treatment);
- •Combined with extensive and uncontrolled extrapulmonary metastases, such as liver metastasis, bone metastasis, and brain metastasis;
- •Have had or currently having other primary malignant tumors;
- •White blood cell < 3×109/L, platelet count < 50×109/L, HGB < 90 g/L;
- •Hepatic and renal insufficiency (creatinine > 2 mg/L; AST and/or ALT > 2 times the normal upper limit);
- •Coagulation dysfunction (INR > 1.5) or known bleeding disease (except lung cancer combined with hemoptysis), or anticoagulation therapy;
- •Patients with active infection requiring antibiotic treatment;
- •Uncontrolled hypertension, diabetes, and cardiovascular disease with obvious symptoms;
- •contrast agent allergy;
- •Women with pregnancy or lactation.
结局指标
主要结局
PFS
时间窗: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
次要结局
- ORR(up to 3 years)
- Overall survival (OS)(up to 3 years)
研究者
Gang Wu
Chief physician
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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