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临床试验/NCT06267170
NCT06267170尚未招募不适用

A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage

Henan Cancer Hospital0 个研究点目标入组 288 人开始时间: 2024年2月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
288
主要终点
Safety (Occurrence of ≥ Grade 3 AE)

研究概览

简要总结

This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy

研究设计

研究类型
Observational
观察模型
Other
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

  • Sign informed consent and join the study voluntarily;
  • Patients diagnosed with extensive small cell lung cancer;
  • Age ≥18 years old;
  • Have at least one measurable lesion (according to RECIST 1.1);
  • The investigators judged that adebrelimab treatment was acceptable;
  • Contraception: Patients should agree that it must be used during the study period and within 6 months after the study ends Effective contraception;

排除标准

  • Allergic to adebrelimab and its excipients;
  • Patients who have also received other immune drugs or therapies;
  • Patients who are participating in other interventional studies;
  • patients with other malignant tumors;
  • Pregnant or lactating women;
  • The investigator considers that the patient is not suitable to participate in any other conditions of the study.

结局指标

主要结局

Safety (Occurrence of ≥ Grade 3 AE)

时间窗: End of each cycle (each cycle is 28 days)

The incidence of grade 3 or higher adverse events

次要结局

  • PFS(End of every two cycles (each cycle is 28 days))
  • ORR(End of every two cycles (each cycle is 28 days))
  • OS(End of every two cycles (each cycle is 28 days))
  • DCR(End of every two cycles (each cycle is 28 days))

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Qiming Wang

Chief physician

Henan Cancer Hospital

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