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Trial Title:
Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment
NCT ID:
NCT06387134
Condition:
Early Stage Lung Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Adenocarcinoma of Lung
Conditions: Keywords:
early stage lung adenocarcinoma
tumor microenvironment
ground glass nodule
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Lifei Xiaoji Wan
Description:
The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on.
Arm group label:
trial group
Intervention type:
Drug
Intervention name:
Conventional treatment with Western medicine
Description:
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".
Arm group label:
control group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mingli Zhao
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingli Zhao, MD
Phone:
0371-66246152
Email:
13937159120@163.com
Start date:
December 1, 2022
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Henan University of Traditional Chinese Medicine
Agency class:
Other
Source:
Henan University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06387134
