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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial group | Experimental | The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time,3 times/day). |
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| control group | Placebo Comparator | The patients in the control group received routine Western medicine treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifei Xiaoji Wan | Drug | The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lung Cancer Quality of Life Scale (FACT-L) | FACT-L scale was used to record the patients' physiological status, social/family status, emotional status and functional status | 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. |
| TCM symptoms and syndromes | 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 | Change from baseline at month 1 and 2. |
| Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body | The changes of tumor body and lesion were observed and the therapeutic effect on tumor was evaluated | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor markers：CEA | Tumor marker CEA levels. | Every 1 month, assessed up to 2 months. |
| Tumor markers：CA211 | Tumor marker CA211 levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingli Zhao, MD | Contact | 0371-66246152 | 13937159120@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mingli Zhao | Recruiting | Zhengzhou | China |
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| Conventional treatment with Western medicine | Drug | Recommended treatment protocols for patients with Stage Ia NSCLC in the "Chinese Society of Oncology Branch of Lung Cancer Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2021 edition)" and the "Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Diagnosis and Treatment Guidelines 2021". |
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| Every 1 month, assessed up to 2 months. |
| Tumor markers：squamous cell carcinoma antigen | Tumor marker squamous cell carcinoma antigen levels. | Every 1 month, assessed up to 2 months. |
| Complete blood count: white blood cells | white blood cells levels. | Every 1 month, assessed up to 2 months. |
| Complete blood count: haemoglobin | haemoglobin levels. | Every 1 month, assessed up to 2 months. |
| Complete blood count: Platelet | Platelet levels. | Every 1 month, assessed up to 2 months. |
| Liver function tests: ALT | Liver function tests ALT levels. | Every 1 month, assessed up to 2 months. |
| Liver function tests: AST | Liver function tests AST levels. | Every 1 month, assessed up to 2 months. |
| Renal function tests: BUN | Renal function tests BUN levels. | Every 1 month, assessed up to 2 months. |
| Renal function tests: Cr | Renal function tests Cr levels. | Every 1 month, assessed up to 2 months. |