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

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

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

Study Overview

• Status: Recruiting
• Conditions: Early Stage Lung Adenocarcinoma
• Intervention / Treatment: Drug: Lifei Xiaoji Wan; Drug: Conventional treatment with Western 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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingli Zhao, MD; Phone Number: 0371-66246152; Email: 13937159120@163.com

Study Locations

• China
  • Zhengzhou, China
    • Recruiting
    • Mingli Zhao
    • Contact: Mingli Zhao, MD; Phone Number: 0371-66246152; Email: 13937159120@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trial group; The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time,3 times/day).	Drug: Lifei Xiaoji Wan; The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on.
Placebo Comparator: control group; The patients in the control group received routine Western medicine treatments.	Drug: Conventional treatment with Western medicine; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: tumor microenvironment; early stage lung adenocarcinoma; ground glass nodule
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: TCM for early-stage LUAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No