Lifei Xiaoji Wan in Treatment of Advanced NSCLC

Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC

This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.

Study Overview

• Status: Recruiting
• Conditions: Advanced Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Lifei Xiaoji Wan; Other: Conventional treatment with Western medicine

Detailed Description

Non-small cell lung cancer (NSCLC) is a disease with high morbidity and mortality, poor prognosis, and a lack of safe and effective treatment. Lifei Xiaoji Wan has significant advantages in the treatment of advanced NSCLC, but the a lack of high-level clinical evaluation evidence and accurate mechanism of action research. According to the previous animal experiments of the team, it was proved that Lifei Xiaoji Wan can significantly inhibit the tumor growth ability of lung cancer mice, and inhibit the proliferation, clonal formation, and migration ability of lung cancer cells. This topic intends to adopt the method of multicenter randomized controlled study to observe the Lifei Xiaoji Wan for advanced NSCLC patients' overall survival (OS), progression-free survival (PFS), Functional Assessment of Cancer Therapy-Lung (FACT-L), TCM symptoms and syndrome and safety, help to clarify the role of Lifei Xiaoji Wan in TCM prevention and treatment of lung cancer, can provide high-level evidence for TCM prevention and treatment of lung cancer research and clinical.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuanyuan Wang, MD; Phone Number: 0371-66248624; Email: 40685685@qq.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • the First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Yuanyuan Wang, MD; Phone Number: 15837180396; Email: 40685685@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Clinical diagnosis of NSCLC.
2. The tumor stage (TNM) stage is from III to IV.
3. 18-80 years old.
4. The expected survival period is> 3 months.

Exclusion Criteria:

1. Early-stage patients with prior surgery and no recurrence.
2. Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
3. Mental illness and other patients 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: Double

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; Other: Conventional treatment with Western medicine; Conventional treatment with Western medicine
No Intervention: control group; The patients in the control group received routine Western medicine treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from enrollment to patient death.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Progression-free survival	Time from enrollment to objective tumor progression or all-cause death.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy-Lung (FACT-L)	Including the physiological status, social / family status, emotional status, functional status and additional concerns, with a total score of 0-144. The higher the score, the more severe the symptoms will be.	Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.
TCM symptoms and syndrome	The improvement of the clinical symptoms, such as cough, expectoration, chest tightness, shortness of breath, fatigue, weakness, and loss of appetite.	Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.
Response Evaluation Criteria in Solid Tumours (RECIST)	patients were collected on Computed Tomography (CT) for imaging analysis and measurement, to observe the changes of tumor bodies and lesions, and to evaluate the efficacy on tumor.	Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.
Tumor markers CEA	Peripheral blood of patients was collected to observe the changes of CEA.	Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
Tumor markers CA211	Peripheral blood of patients was collected to observe the changes of CA211.	Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Tumor markers Squamous Cell Careinoma Antigen	Peripheral blood of patients was collected to observe the changes of Squamous Cell Careinoma Antigen.	Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Complete blood count: White blood cells levels	white blood cells levels	Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Haemoglobin levels	haemoglobin levels	Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Platelet levels	Platelet levels	Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Liver function: ALT levels	ALT levels	Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
Liver function: AST levels	AST levels	Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
Renal function: BUN levels	BUN levels	Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
Renal function: Cr levels	Cr levels	Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; traditional Chinese medicine; advanced non small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TCM for advanced NSCLC

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