NCT05991180招募中不适用
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer and Assessment of Biomarkers
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年12月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients must be ≥18 years.
- •Provision of fully informed consent prior to any study specific procedures.
- •Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
- •According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
排除标准
- 未提供
结局指标
主要结局
ORR
时间窗: 2 years
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
次要结局
- PFS(2 years)
- OS(2 years)
研究者
Yongchang Zhang
Professor, Deputy Director of Thoracic Oncology Department
Hunan Province Tumor Hospital
研究点 (1)
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