Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study
试验速览
- 阶段
- 2 期
- 入组人数
- 118
- 主要终点
- Progression-free survival
研究概览
简要总结
The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.
详细描述
The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.
In addition, gene spectrum detection and Mini-PDX are applied for validation of pharmacodynamic.
Results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for LCNEC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology
- •Estimated life expectancy over 3 months
- •Performance status 0,1,2
- •Signed informed consent
- •Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine < 2.5 mg/dL (221 mmol/L); serum AST or ALT <5.0 x upper limit of normal (ULN); serum total bilirubin <2.0 mg/dL (34 mmol/L)
排除标准
- •History of chemotherapy or molecular targeted therapy
- •Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy
- •Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy
- •Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Pregnant or lactating
- •Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
研究组 & 干预措施
Group A
Patients will be administered with etoposide plus carboplatin as first-line treatment.
干预措施: etoposide plus carboplatin (Drug)
Group B
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
干预措施: Paclitaxel plus carboplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 6 months
Interval from randomization to disease progression, or untolerated toxicity
次要结局
- Tumor response(2 months)
研究者
Zhou Zhen
Chief Physician
Shanghai Chest Hospital