Clinical trial NCT06387134: Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Stage Lung Adenocarcinoma
Keywords: early stage lung adenocarcinoma
tumor microenvironment
ground glass nodule
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Lung Cancer Quality of Life Scale (FACT-L)
timeFrame: 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.
measure: TCM symptoms and syndromes
timeFrame: Change from baseline at month 1 and 2.
measure: Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body
timeFrame: 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).
Secondary outcomes:
measure: Tumor markers：CEA
timeFrame: Every 1 month, assessed up to 2 months.
measure: Tumor markers：CA211
timeFrame: Every 1 month, assessed up to 2 months.
measure: Tumor markers：squamous cell carcinoma antigen
timeFrame: Every 1 month, assessed up to 2 months.
measure: Complete blood count: white blood cells
timeFrame: Every 1 month, assessed up to 2 months.
measure: Complete blood count: haemoglobin
timeFrame: Every 1 month, assessed up to 2 months.
measure: Complete blood count: Platelet
timeFrame: Every 1 month, assessed up to 2 months.
measure: Liver function tests: ALT
timeFrame: Every 1 month, assessed up to 2 months.
measure: Liver function tests: AST
timeFrame: Every 1 month, assessed up to 2 months.
measure: Renal function tests: BUN
timeFrame: Every 1 month, assessed up to 2 months.
measure: Renal function tests: Cr
timeFrame: Every 1 month, assessed up to 2 months.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Mingli Zhao
Study officials:
References: