The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The goal of this clinical trial is to learn about Drug loaded microspheres for bronchial artery chemoembolization (DEB-BACE) combined with anlotinib and adebelimumab in patients with advanced NSCLC after second-line treatment.
The main question it aims to answer is:
The efficacy and safety of Drug Loading Beads Bronchial Arterial Chemoembolization (DEB-BACE) combined with Anlotinib and Adebelimumab in the third line treatment of advanced NSCLC.
Participants will receive DEB-BACE treatment, rest for 1 week and then undergo 1 cycle of treatment with combination of Anlotinib and Adebelimumab. With a maximum of 4 DEB-BACE treatments depending on the therapeutic effect, followed by continued treatment with Anlotinib and Adebelimumab.
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, gender unlimited;
- •According to the Diagnosis and Treatment Guidelines for Primary Lung Cancer (2018 Edition), NSCLC was diagnosed by pathological histology;
- •TNM staging is III - IV;
- •Failure of second-line treatment according to the CSCO guidelines;
- •ECOG PS score ≤ 2 points;
- •Estimated survival time>3 months;
- •Sign informed consent form
排除标准
- •Individuals who have previously received interventional therapy (iodine particle implantation, ablation, BACE treatment), or have received PD-L1 inhibitor immunotherapy during the first or second line standard treatment period of the patient;
- •Patients with other malignant tumors that have not been cured;
- •White blood cells<3 × 109/L, absolute value of neutrophils<1.5 × 109/L, neutrophil/lymphocyte ratio ≥ 3, platelet count<50 × 109/L, hemoglobin concentration<90 g/L;
- •Liver and kidney dysfunction (creatinine>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>twice the normal upper limit;
- •Central squamous cell carcinoma with cavity features;
- •Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;
- •Patients with concurrent active infections who require antibiotic treatment;
- •Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;
- •Contrast agent allergy;
- •Women with concurrent pregnancy or lactation
研究组 & 干预措施
experimental group
干预措施: Anlotinib (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
objective response rate
次要结局
- AE(3 years)
- OS(3 years)
- DoR(3 years)
- PFS(2 years)
- DCR(3 years)