Lifei Xiaoji Wan in Treatment of Advanced NSCLC

Advanced Non Small Cell Lung Cancer Clinical Trial

Official title:

Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406166
• Other study ID #: TCM for advanced NSCLC
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Henan University of Traditional Chinese Medicine
• Contact: Yuanyuan Wang, MD
• Phone: 0371-66248624
• Email: 40685685[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Henan University of Chinese Medicine	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Complete blood count: Haemoglobin levels	haemoglobin levels	Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
Secondary	Complete blood count: Platelet levels	Platelet levels	Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Secondary	Liver function: ALT levels	ALT levels	Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
Secondary	Liver function: AST levels	AST levels	Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
Secondary	Renal function: BUN levels	BUN levels	Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
Secondary	Renal function: Cr levels	Cr levels	Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.