NCT07072299尚未招募不适用
DEB-BACE for Primary Lung Cancer: A Retrospective, Single-Arm, Multicenter Study on Efficacy and Safety
Gang Wu, MD0 个研究点目标入组 1,213 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,213
- 主要终点
- ORR
研究概览
简要总结
This is a retrospective, single-arm, multicenter clinical study designed to evaluate the efficacy and safety of DEB-BACE (Drug-Eluting Bead Bronchial Artery Chemoembolization) in the treatment of primary lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 unrestricted;
- •Diagnosed with primary lung cancer based on the Primary Lung Cancer Diagnosis and Treatment Guidelines (2022 Edition) through histopathological examination;
- •At least one measurable lesion (evaluated according to RECIST 1.1 criteria);
- •Previously received at least one DEB-BACE treatment;
- •ECOG PS score ≤ 2;
- •Complete patient case records.
排除标准
- •Presence of extensive and uncontrolled extrapulmonary brain metastasis lesions;
- •Irreversible coagulation dysfunction within a short period of time;
- •Uncontrollable hypertension, diabetes, or significant cardiovascular diseases with obvious symptoms;
- •Allergy to contrast agent;
- •Pregnant or lactating women;
- •Patients whose condition, as judged by the investigator, poses a serious threat to patient safety or hinders their participation in the study.
结局指标
主要结局
ORR
时间窗: up to 1 years
ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to mRECIST 1.1 criteria
次要结局
- PFS(up to 1 years)
- OS(up to1 years)
研究者
Gang Wu, MD
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Zhengzhou University
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