A PhaseⅡa, Placebo Parallel Control, Central Randomized, Double Blind, Dosage Exploring and Multi-Center Study to Evaluate the Efficacy and Safety of Ginsenoside H Dripping Pills in Patients With Advanced NSCLC (Syndrome Of Qi-Deficiency)
试验速览
- 阶段
- 2 期
- 入组人数
- 144
- 试验地点
- 9
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
- •The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.
- •The TCM Syndrome diagnosis of Qi-Deficiency.
- •Aged 18-75 years, both male and female.
- •ECOG performance status 0-
- •Expected to survive more than 3 months.
- •Joined in the test voluntarily and signed the Informed consent by GCP regulation.
排除标准
- •Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
- •Patients with significant cachexia.
- •Untreated symptomatic brain metastases.
- •4 .Allergic constitution, or for a variety of drug allergy.
- •5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.
- •Participated in other clinical trial within 3 months.
- •Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.
- •Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.
- •Not fit for the clinical trial judged by the investigator.
研究组 & 干预措施
Ginsenoside H dripping pills
Drug: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.
干预措施: Ginsenoside H dripping pills (Drug)
Ginsenoside H dripping pills+Placebo
Drug: Ginsenoside H dripping pills ,Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.
干预措施: Ginsenoside H dripping pills+Placebo (Drug)
Placebo
Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: through study completion, an average of 1 year
Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment
次要结局
- Overall Survival (OS)(through study completion, an average of 1 year)
- Symptoms scores of TCM(through study completion, an average of 1 year)
- Time to progression(TTP)(through study completion, an average of 1 year)
- Quality of Life(through study completion, an average of 1 year)
- Cancer-related fatigue(through study completion, an average of 1 year)