Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.
详细描述
Small-cell lung cancer (SCLC) is an aggressive tumor and most patients experienced relapse or progression after standard chemotherapy. Topotecan is active as second-line therapy for SCLC patients. However, even in sensitive patients, only 20% response rate and a median time to progression of 12 weeks are observed. New therapeutic options in SCLC are needed. Apatinib is a small-molecule tyrosine kinase inhibitor that inhibits vascular endothelial growth factor receptor 2. It has been approved in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. The efficacy of apatinib in SCLC is unknown. The purpose of this study is to determine whether topotecan plus apatinib are superior to topotecan alone as second-line therapy in small-cell lung cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •limited or extensive-stage SCLC who had failed to first-line therapy
- •≥18 years old
- •Eastern Cooperative Oncology Group performance status ≤2
- •at least one measurable lesion as defined by RECIST (version 1.1)
- •at least one measurable lung tumor lesion
- •WBC count ≥3,500/μL, neutrophils ≥1,500μL, platelets ≥100,000μL, hemoglobin ≥ 9.0 g/dL
- •AST, and ALT ≤2 × the upper limit of normal or ≤5 × the upper limit of normal with liver metastases.
排除标准
- •symptomatic CNS metastases
- •concomitant or previous malignancies within the last 5 years
- •severe comorbidities; prior topotecan therapy
- •hypersensitivity or other contraindication to the study drugs.
研究组 & 干预措施
Apatinib and topotecan
Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.
干预措施: Apatinib (Drug)
Apatinib and topotecan
Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5, apatinib 250mg/d, every 21 days, until disease progression.
干预措施: Topotecan (Drug)
Topotecan
Patients receive IV topotecan 1.5 mg/m2/d on days 1 through 5 every 21 days, until disease progression.
干预措施: Topotecan (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 1 year
次要结局
- Response rate(1 year)
- Toxicity assessed by common terminology criteria for adverse events(CTCAE) V4.0(1 year)
研究者
Min-hang Zhou
doctor
First Hospitals affiliated to the China PLA General Hospital