Study on the Therapeutic Effect of Lifei Xiaoji Wan on Lung Adenocarcinoma in the Early Stage of Ground Glass Nodule (Ia Stage) and Its Effect on Tumor Microenvironment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body
研究概览
简要总结
This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine
详细描述
Lung cancer is a malignant tumor with the highest morbidity and mortality. The microenvironment of tumor plays an important role in its occurrence and development.Traditional Chinese medicine has great advantages in the prevention and treatment of ground glass pulmonary nodules, but there is a lack of high-level clinical evaluation evidence and precise mechanism of action.Lifei Xiaoji Wan is a prescription based on the theory of "gas accumulation causing cancer". It has good curative effect in treating non-small cell lung cancer.
In this study, a single-center randomized controlled study was used to set up a treatment group and a control group to observe and evaluate the clinical efficacy of Lifeixiaoji pills on patients with early stage lung adenocarcinoma of ground glass nodules. Flow cytometry, PCR array and multiple fluorescence immunofluorescence were used to detect the tumor microenvironment in lung cancer tissues. To investigate the effect of Lifeixiaoji pill on tumor microenvironment and its mechanism of action on early lung adenocarcinoma.
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 (Investigator)
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
- •It met the diagnostic criteria of non-small cell lung cancer and was confirmed by pathology, cytology and other relevant examinations.
- •Preoperative thin-slice CT showed pure ground glass pulmonary nodules with a size of 10mm-30mm. Intraoperative and postoperative pathology indicated adenocarcinoma, and the tumor stage (TNM) was stage Ia.
- •Age: 18-75 years old
- •Expected survival >5 years
- •Informed consent and sign informed consent
排除标准
- •Patients who have undergone surgery
- •Patients with serious dysfunction of heart, liver, lung, kidney and other important organs
- •Patients with mental illness who 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)
control group
The patients in the control group received routine Western medicine treatments.
干预措施: Conventional treatment with Western medicine (Drug)
结局指标
主要结局
Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body
时间窗: Every 1 month, assessed up to 2 months, CT was collected for imaging analysis and measurement.RECIST criteria for tumor efficacy evaluation:The extent of growth or shrinkage of the target lesion (unit: mm).
The changes of tumor body and lesion were observed and the therapeutic effect on tumor was evaluated
Lung Cancer Quality of Life Scale (FACT-L)
时间窗: There are 36 items in the scale, and each item is scored as 0~4 points, with a total score range of 0-144 points (minimum: 0 points; maximum value: 144 points).Higher dimensions and total scores indicate higher.Change from baseline at month 1 and 2.
FACT-L scale was used to record the patients' physiological status, social/family status, emotional status and functional status
TCM symptoms and syndromes
时间窗: Change from baseline at month 1 and 2.
The evaluation was carried out according to the standard of TCM syndrome of lung cancer in Guiding Principles for Clinical Research of New Chinese Medicine
次要结局
- Tumor markers：CEA(Every 1 month, assessed up to 2 months.)
- Liver function tests: AST(Every 1 month, assessed up to 2 months.)
- Tumor markers：CA211(Every 1 month, assessed up to 2 months.)
- Tumor markers：squamous cell carcinoma antigen(Every 1 month, assessed up to 2 months.)
- Complete blood count: white blood cells(Every 1 month, assessed up to 2 months.)
- Liver function tests: ALT(Every 1 month, assessed up to 2 months.)
- Renal function tests: Cr(Every 1 month, assessed up to 2 months.)
- Complete blood count: Platelet(Every 1 month, assessed up to 2 months.)
- Complete blood count: haemoglobin(Every 1 month, assessed up to 2 months.)
- Renal function tests: BUN(Every 1 month, assessed up to 2 months.)