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临床试验/NCT06323265
NCT06323265招募中不适用

A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Progression free survival (PFS)

研究概览

简要总结

The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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;
  • Patients with extensive stage small cell lung cancer confirmed by histopathology;
  • Normal function of major organs;
  • Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

排除标准

  • Patients with drug allergy sufferers;
  • Serious and uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc;
  • History of psychiatric drugs abuse and can't quit or patients with mental disorders;
  • The researchers think inappropriate.

研究组 & 干预措施

Experimental

干预措施: Adebrelimab + chemotherapy (Drug)

Experimental

干预措施: ±chest radiotherapy (Radiation)

结局指标

主要结局

Progression free survival (PFS)

时间窗: evaluated in 24 months since the treatment began

Baseline to measured date of progression or death from any cause

次要结局

  • Objective response rate (ORR)(tumor assessment every 6 weeks since the treatment began,up to 24 months)
  • Disease control rate (DCR)(tumor assessment every 6 weeks since the treatment began,up to 24 months)
  • Duration of Overall Response(DoR)(tumor assessment every 6 weeks since the treatment began,up to 24 months)
  • Adverse events(up to 24 months)
  • Overall survival (OS)(the first day of treatment to death or last survival confirm date,up to 24 months)

研究者

发起方
Hebei Medical University Fourth Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun wang

Study Principal Investigator

Hebei Medical University Fourth Hospital

研究点 (1)

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