The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 144
- 主要终点
- Disease-free survival Rate
研究概览
简要总结
Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.
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
- •Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
- •Accept chemotherapy for the first time 6 weeks after operation
- •Age of 18-75 years old
- •Eastern Cooperative Oncology Group-PS≤2
- •N>1.5×109/L、PLT> 100 × 109/L、Hb>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
- •Voluntary participation in the prospective study with signed informed consent
排除标准
- •No pathology-confirmed diagnosis patients
- •Patients with overall survival time<6 months
- •Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
- •Pregnant or breast feeding patients
- •Patients with uncontrollable mentally disease
- •Patients with diabetes
研究组 & 干预措施
Jinfukang + Chemotherapy Group
干预措施: Jinfukang Koufuye (Drug)
Jinfukang + Chemotherapy Group
干预措施: Docetaxel (Drug)
Jinfukang + Chemotherapy Group
干预措施: Pemetrexed (Drug)
Jinfukang + Chemotherapy Group
干预措施: Cisplatin (Drug)
Chemotherapy Group
干预措施: Docetaxel (Drug)
Chemotherapy Group
干预措施: Pemetrexed (Drug)
Chemotherapy Group
干预措施: Cisplatin (Drug)
结局指标
主要结局
Disease-free survival Rate
时间窗: 2 years
From the very beginning of the randomization to the end point when disease relapse or death because of any reason
次要结局
未报告次要终点
研究者
lihegen
Director of Oncology Department Longhua Hospital
Shanghai University of Traditional Chinese Medicine