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Trial Title:
Lifei Xiaoji Wan in Treatment of Advanced NSCLC
NCT ID:
NCT06406166
Condition:
Advanced Non Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
advanced non small cell lung cancer
traditional Chinese medicine
randomized controlled trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, 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:
Other
Intervention name:
Conventional treatment with Western medicine
Description:
Conventional treatment with Western medicine
Arm group label:
trial group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Henan University of Chinese Medicine
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanyuan Wang, MD
Phone:
15837180396
Email:
40685685@qq.com
Start date:
June 1, 2022
Completion date:
December 31, 2024
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/NCT06406166
