NCT04825925尚未招募不适用
Drug-eluting Beads Bronchial Arterial Chemoembolization in Stage II-III Non-small-cell Lung Cancer Patients Failed, Refused or Ineligible to Receive Standard Treatments
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a multicenter, prospective, single-arm clinical study to determine the efficacy and safety of Drug-eluting beads bronchial arterial chemoembolization（DEB-BACE） in stage II-III NSCLC patients who failed, refused or ineligible to receive standard treatments
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
- •Patients ≥ 18 years old, of any sex;
- •Patients who have histopathological proof of NSCLC according to the standard of diagnosis and treatment of primary lung cancer（V2018）;
- •Confirmed TNM stage is II-III of NSCLC;
- •Patients who were failed, refused or assessed ineligible by MDT to receive conventional Second-Line treatments (surgery, chemoradiotherapy, targeted and immunotherapy)；
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;
- •Life expectancy of > 3 months;
- •Patients volunteered to participate in this study and signed informed consent, with good compliance;
排除标准
- •Patients received interventional therapy (I seeds implantation, Ablation, BACE) before;
- •A history combined with other malignant tumors and not cured;
- •WBC<3×109/L、LYM<1.5×109/L、NLR≥3、PLT<50×109/L、HGB<90 g/L;
- •Insufficient of liver and renal function (Cr>176.8 µmol/L; AST and/or ALT>2 folds of normal value)；
- •Combined with uncorrectable coagulation dysfunction or active massive hemoptysis;
- •Combined with active affection and need antibiotic treatment;
- •Uncontrollable hypertension, diabetes, cardiovascular disease with obvious symptoms;
- •Known to be hypersensitive to contrast agent;
- •Pregnant or breastfeeding women;
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death, up to 36 months
Time from the first DEB-BACE treatment to either radiological progression after the second DEB-BACE treatment or death
次要结局
- Disease control rate (DCR)(1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months)
- Overall survival (OS)(Time from the first DEB-BACE treatment to death or up to 36 months)
- Objective response rate (ORR)(1, 3, 6 months after the first DEB-BACE treatment, up to death or 36months)
- Recurrence rate of hemoptysis(Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months)
- Tumor biomarker (CEA, SCC)(Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months)
- Quality of life score (EORTC, QLQ-30)(Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score (ECOG PS)(Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months)
- VAS pain grade(Every two months after treatment when the patient was assessed complete response; every month after treatment when assessed partial response, stable disease or progressive disease; up to progressive disease after the second treatment or within 36 months)
研究者
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