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

NCT ID: NCT06387134

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Early Stage Lung Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

trial group

The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time,3 times/day).

Group Type EXPERIMENTAL

Lifei Xiaoji Wan

Intervention Type DRUG

The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on.

control group

The patients in the control group received routine Western medicine treatments.

Group Type PLACEBO_COMPARATOR

Conventional treatment with Western medicine

Intervention Type DRUG

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".

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lifei Xiaoji Wan

The Lifei Xiaoji Wan consists of ginseng, blackhead,rhubarb, aster, forehu, and thin on.

Intervention Type 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".

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mingli Zhao

Zhengzhou, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mingli Zhao, MD

Role: CONTACT

0371-66246152

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mingli Zhao, MD

Role: primary

0371-66246152

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TCM for early-stage LUAD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Survival Outcomes of Lung Cancer
NCT03647098 RECRUITING
Bioinformation Therapy for Lung Cancer
NCT03239171 COMPLETED PHASE2/PHASE3