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临床试验/NCT07072299
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

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

发起方
Gang Wu, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gang Wu, MD

The First Affiliated Hospital of Zhengzhou University

The First Affiliated Hospital of Zhengzhou University

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