Advanced Non Small Cell Lung Cancer
Conditions
Keywords
advanced non small cell lung cancer, traditional Chinese medicine, randomized controlled trial
Brief 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.
Interventions
DRUGLifei Xiaoji Wan
The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on
Conventional treatment with Western medicine
Sponsors
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. | Time from enrollment to patient death. |
| Progression-free survival | 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. | Time from enrollment to objective tumor progression or all-cause death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Evaluation Criteria in Solid Tumours (RECIST) | Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12. | 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. |
| Tumor markers CEA | Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12. | Peripheral blood of patients was collected to observe the changes of CEA. |
| Tumor markers CA211 | Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12. | Peripheral blood of patients was collected to observe the changes of CA211. |
| Tumor markers Squamous Cell Careinoma Antigen | Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12. | Peripheral blood of patients was collected to observe the changes of Squamous Cell Careinoma Antigen. |
| Complete blood count: White blood cells levels | Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12. | white blood cells levels |
| Functional Assessment of Cancer Therapy-Lung (FACT-L) | Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12. | 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. |
| Complete blood count: Platelet levels | Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12. | Platelet levels |
| Liver function: ALT levels | Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12. | ALT levels |
| Liver function: AST levels | Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12. | AST levels |
| Renal function: BUN levels | Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12. | BUN levels |
| Renal function: Cr levels | Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12. | Cr levels |
| Complete blood count: Haemoglobin levels | Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12. | haemoglobin levels |
| TCM symptoms and syndrome | Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12. | The improvement of the clinical symptoms, such as cough, expectoration, chest tightness, shortness of breath, fatigue, weakness, and loss of appetite. |
Countries
China
Contacts
Primary ContactYuanyuan Wang, MD
Outcome results
None listed