A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
详细描述
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
- •Patients receiving chemotherapy for the first time in 6 weeks after surgery;
- •Age from 18 Years to 70 Years;
- •The liver and renal function were normal,and no other disease.
- •Patients compliance is good ang can understand the situation of this study and signed informed consent
排除标准
- •Patients without clear pathological diagnosis;
- •The expected survival period is morn than 6 months;
- •Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
- •Patients with pregnancy or lactation;
- •Persons with a history of less control.
研究组 & 干预措施
Cisplatin
Cisplatin
干预措施: Cisplatin (Drug)
Pemetrexed
Pemetrexed
干预措施: Pemetrexed (Drug)
Jinfukang
Jinfukang
干预措施: JinFuKang (Drug)
Jinfukang
Jinfukang
干预措施: Cisplatin (Drug)
Jinfukang
Jinfukang
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.
It is decided by a doctor via the clinical examinations
次要结局
- Overall survival(Two years)
- Circulating Tumor Cell(24months)
研究者
jianhuitian
Clinical Professor
Shanghai University of Traditional Chinese Medicine