Molecular Subtyping of Extensive Stage Small Cell Lung Cancer and Relevent Clinical Significance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To validate the predictive value of transcriptome-based molecular subtyping of extensive stage small cell lung cancer (SCLC) for the efficacy of programmed death-1(PD-1)/programmed death-ligand1(PD-L1) inhibitor in the first line setting; to explore the differences of immune microenvironment between different SCLC subtypes to reveal the mechanisms of immunotherapy resistance of SCLC
详细描述
This retrospective observational study examines the predictive value of transcriptome-based molecular subtyping of extensive stage SCLC for PD-1/PD-L1 inhibitor efficacy and explores immune microenvironment differences between subtypes to uncover immunotherapy resistance mechanisms. Patients with extensive stage SCLC receiving first-line standard treatment are enrolled, and baseline tumor tissue and peripheral blood samples are collected for transcriptome sequencing and immunohistochemistry (IHC). Based on results, patients are classified into four molecular subtypes, and treatment efficacy and safety are recorded. The study compares the efficacy between SCLC subtypes to determine if molecular typing predicts immunotherapy efficacy and investigates immune microenvironment differences between subtypes to uncover resistance mechanisms. Treatment regimens follow first-line extensive stage SCLC guidelines, including cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitors, with options determined by the supervising physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The enrolled subjects shall meet all the following conditions at the same time.
- •Male or female, aged 18 to 100 years
- •Patients with untreated advanced small cell lung cancer clearly diagnosed by histopathology
- •Be able to provide tumor biopsy tissue sample for molecular analysis
- •Eastern Cooperative oncology Group (ECOG) score: 0~2
- •Expected survival of more than 3 months.
- •Has at least 1 measurable or evaluable tumor lesion with a longest diameter ≥ 10 mm at baseline (in case of lymph nodes, a shortest diameter ≥ 15 mm is required) according to RECIST v1.1
- •Received first-line chemotherapy or chemotherapy＋PD-(L)1 inhibitor and be able to provide complete treatment information and efficacy evaluation results.
- •Voluntary signed informed consent and expected good compliance.
排除标准
- •Those meeting any of the following conditions may not be included.
- •Patient unable to tolerate chemotherapy.
- •Patients unable to provide tumor tissue samples for testing
- •Patients with other malignant tumors or a history of other malignant tumors
- •Patients have any other reason to be unfit to participate in this study.
研究组 & 干预措施
immunotherapy cohort
Extensive stage SCLC patients receiving first-line chemotherapy plus PD-(L)1 antibody treatment will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc.
干预措施: PD-(L)1 antibody immunotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2022.4.1-2023.12.31
From the start of first-line treatment until disease progression or death due to any cause
次要结局
- molecular subtyping and tumor microenvironment biomarkers(2022.4.10-2023.12.31)
- Overall survival(2022.4.10-2024.12.31)
- Objective response rate(2022.4.10-2023.12.31)