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

NCT06387134 | Recruiting DMC

• 1 other identifier: TCM for early-stage LUAD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Early Stage Lung Adenocarcinoma

Keywords

early stage lung adenocarcinoma; tumor microenvironment; ground glass nodule

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Tumor markers：CEA

  Every 1 month, assessed up to 2 months.

• Tumor markers：CA211

  Every 1 month, assessed up to 2 months.

• Tumor markers：squamous cell carcinoma antigen

  Every 1 month, assessed up to 2 months.

• Complete blood count: white blood cells

  Every 1 month, assessed up to 2 months.

• Complete blood count: haemoglobin

  Every 1 month, assessed up to 2 months.

Study Arms (2)

trial group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Drug: Conventional treatment with Western medicine

Interventions

Lifei Xiaoji Wan DRUG

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

trial group

Conventional treatment with Western medicine 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".

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

Mingli Zhao

Zhengzhou, China

RECRUITING

Central Study Contacts

Mingli Zhao, MD

CONTACT

0371-66246152; 13937159120@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: December 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: May 31, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)