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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on
Conventional treatment with Western medicine
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
RECRUITINGOverall survival
Time from enrollment to patient death.
Time frame: 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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
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Tumor markers CA211
Peripheral blood of patients was collected to observe the changes of CA211.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Platelet levels
Platelet levels
Time frame: Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Liver function: ALT levels
ALT levels
Time frame: Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
Liver function: AST levels
AST levels
Time frame: Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
Renal function: BUN levels
BUN levels
Time frame: Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
Renal function: Cr levels
Cr levels
Time frame: Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.