Advanced Non-Small-Cell Lung Cancer
Conditions
Interventions
TCM group:TCM Yi-Fei San-Jie Pill as Maintenance Therapy
Control group:Blank
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed by the way of pathological cytology and/or histology as non-small cell lung cancer; 2. Diagnosed as IIIB-IV stage (according to the international association for the study of lung cancer IASLC chest tumor staging manual Version 8) or tumor recurrence after treatment; 3. Males or females aged 18-75 agree to sign the informed consent; 4. Patients who have previously received 4 courses of chemotherapy of platinum-based dual-drug regimen for less than 1.5 months ,and the efficacy evaluation is SD,PR or CR; 5. Patients without obvious organ dysfunction, and whose liver and kidney function and bone marrow reserve are normal. Specific indicators:Liver function: blood bilirubin =3.0x10^9/L, absolute value of neutrophils (ANC) >=1.5x10^9/L, platelet (PLT) >=80x1069/L, hemoglobin (HGB) >=80g/L; 6. Physical condition (PS) score 0-2 (refer to ECOG PS score standard), expected survival >=3 months; 7. Patients must have measurable target lesions examined by CT or MRI according to RECIST 1.1; 8. Patients without serious drug allergy history.
Exclusion criteria
Exclusion criteria: 1. Meet the indications for EGFR, ALK, ROS1 and other targeted therapy; 2. Have previously received other antitumor treatments such as molecular targeted therapy, immunotherapy, anti-tumor angiogenesis targeted therapy, local cryoablation therapy, radiotherapy, etc., local perfusion therapy of chest and abdomen water; 3. In any conditions that may prevent the subject from completing the follow-up process, including but not limited to serious and uncontrollable organic lesions or infections, unstable angina pectoris, congestive heart failure, etc.; Severe liver and kidney dysfunction; Patients with uncontrolled neurological, psychiatric or psychiatric disorders with symptoms; The condition of central nerve metastasis has not been controlled, with obvious cranial hypertension or neuropsychiatric symptoms; 4. Participating in other drug tests at the same time; 5. Have recieved the latest chemotherapy for more than 1.5 months; 6. Planning pregnancy or breastfeeding or have already been pregnant; 7. Unable to cooperate with visitors; 8. Allergic to Yi-Fei San-Jie Pill.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overal Survival;quality of life;adverse event; | — |
Countries
China
Contacts
Public ContactLi-zhu Lin
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed