Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.
详细描述
Non-small cell lung cancer (NSCLC) is a disease with high morbidity and mortality, poor prognosis, and a lack of safe and effective treatment. Lifei Xiaoji Wan has significant advantages in the treatment of advanced NSCLC, but the a lack of high-level clinical evaluation evidence and accurate mechanism of action research. According to the previous animal experiments of the team, it was proved that Lifei Xiaoji Wan can significantly inhibit the tumor growth ability of lung cancer mice, and inhibit the proliferation, clonal formation, and migration ability of lung cancer cells. This topic intends to adopt the method of multicenter randomized controlled study to observe the Lifei Xiaoji Wan for advanced NSCLC patients' overall survival (OS), progression-free survival (PFS), Functional Assessment of Cancer Therapy-Lung (FACT-L), TCM symptoms and syndrome and safety, help to clarify the role of Lifei Xiaoji Wan in TCM prevention and treatment of lung cancer, can provide high-level evidence for TCM prevention and treatment of lung cancer research and clinical.
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
- Double (Participant, Investigator)
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
- 否
入选标准
- •Clinical diagnosis of NSCLC.
- •The tumor stage (TNM) stage is from III to IV.
- •18-80 years old.
- •The expected survival period is> 3 months.
排除标准
- •Early-stage patients with prior surgery and no recurrence.
- •Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
- •Mental illness and other patients were unable to complete the study.
研究组 & 干预措施
trial group
The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day).
干预措施: Lifei Xiaoji Wan (Drug)
trial group
The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day).
干预措施: Conventional treatment with Western medicine (Other)
结局指标
主要结局
Overall survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time from enrollment to patient death.
Progression-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time from enrollment to objective tumor progression or all-cause death.
次要结局
- Tumor markers CA211(Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.)
- Complete blood count: White blood cells levels(Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.)
- Liver function: ALT levels(Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.)
- Functional Assessment of Cancer Therapy-Lung (FACT-L)(Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.)
- Response Evaluation Criteria in Solid Tumours (RECIST)(Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.)
- Liver function: AST levels(Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.)
- TCM symptoms and syndrome(Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.)
- Tumor markers Squamous Cell Careinoma Antigen(Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.)
- Complete blood count: Haemoglobin levels(Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.)
- Tumor markers CEA(Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.)
- Renal function: Cr levels(Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.)
- Complete blood count: Platelet levels(Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.)
- Renal function: BUN levels(Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.)