Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
TCM group:Yi Fei Xiao Ji Decoction Combined with EGFR-TKIs
control group:EGFR-TKIs
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients with histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC); (2) Patients harboring EGFR sensitizing mutations; (3) Patients diagnosed with Qi-Yin Deficiency Syndrome based on Traditional Chinese Medicine (TCM) pattern differentiation; (4) Age between 18 and 80 years (inclusive) regardless of gender (premenopausal women must have a negative urine HCG test); (5) Karnofsky Performance Status (KPS) score =60 and life expectancy =6 months; (6) No significant abnormalities in pretreatment complete blood count (CBC) cardiac/pulmonary function or hepatic/renal function; (7) Patients fully informed of the study demonstrating good compliance and voluntarily signing the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with intellectual disability or psychiatric disorders (e.g. depression mania); Women who are planning pregnancy pregnant or lactating; Patients with severe or uncontrolled organic diseases or active infections; Patients receiving concurrent radiotherapy chemotherapy or immunotherapy; Patients with uncontrolled brain metastases accompanied by central nervous system (CNS) symptoms; Patients with concurrent malignancies (other than NSCLC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Immune Cell Markers (CD4 CD8 CD19 CD56 etc.) Before and After Treatment;TCM Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky Performance Status (KPS);EORTC-QLQ-C30; | — |
Countries
China
Contacts
Public ContactHuirong Zhu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed