Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment

Not Applicable

Recruiting

• Conditions: Early Stage Lung Adenocarcinoma
• Interventions: Drug: Lifei Xiaoji Wan; Drug: Conventional treatment with Western medicine

• Registration Number: NCT06387134
• Lead Sponsor: Henan University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trial group	Lifei Xiaoji Wan	The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time,3 times/day).
control group	Conventional treatment with Western medicine	The patients in the control group received routine Western medicine treatments.

Primary Outcome Measures

Name	Time	Method
Lung Cancer Quality of Life Scale (FACT-L)	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	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
Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body	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

Secondary Outcome Measures

Name	Time	Method
Tumor markers：squamous cell carcinoma antigen	Every 1 month, assessed up to 2 months.	Tumor marker squamous cell carcinoma antigen levels.
Complete blood count: white blood cells	Every 1 month, assessed up to 2 months.	white blood cells levels.
Tumor markers：CEA	Every 1 month, assessed up to 2 months.	Tumor marker CEA levels.
Liver function tests: AST	Every 1 month, assessed up to 2 months.	Liver function tests AST levels.
Tumor markers：CA211	Every 1 month, assessed up to 2 months.	Tumor marker CA211 levels.
Liver function tests: ALT	Every 1 month, assessed up to 2 months.	Liver function tests ALT levels.
Renal function tests: Cr	Every 1 month, assessed up to 2 months.	Renal function tests Cr levels.
Complete blood count: haemoglobin	Every 1 month, assessed up to 2 months.	haemoglobin levels.
Complete blood count: Platelet	Every 1 month, assessed up to 2 months.	Platelet levels.
Renal function tests: BUN	Every 1 month, assessed up to 2 months.	Renal function tests BUN levels.

Trial Locations

Locations (1)

Mingli Zhao; 🇨🇳 Zhengzhou, China