NCT06387134

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Stage Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Lifei Xiaoji Wan	The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on.
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".

Timeline

• Start date: 2022-12-01
• Primary completion: 2025-01-01
• Completion: 2025-05-31
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: China