non-small cell lung cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) pathological histology and/or cytology diagnosis IIIb ~ IV non-small cell lung cancer; 2) patients who met the syndrome differentiation diagnosis of qi and blood deficiency syndrome in traditional Chinese medicine before enrollment; 3) the disease was stable after >=4 cycles of first-line chemotherapy (whole-brain radiotherapy was allowed to be used in patients with forebrain metastasis to a stable state), and within 30 days after the end of chemotherapy; 4) at least 1 measurable lesion (RECIST standard version 1.1); 5) ECOG score <=2, expected to survive for more than 3 months; 6) before enrollment, the adverse events occurred during chemotherapy were determined by the researcher according to CTCAE to have recovered to level 1 (except hair loss); 7) Aged 18 ~ 80 years old; 8) those who voluntarily participate in the study and have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) uncontrolled brain metastases; 2) patients with positive gene test results of specific targeted therapy (EGFR positive or ALK positive or ROS1 positive or pd-l1 >=50%) before enrollment; 3) the laboratory examination met any of the following criteria: white blood cells < 3.0x10^9/L, neutrophils < 1.5x10^9/L, platelets < 6x10^10/L, red blood cells < 2x10^12/L, hemoglobin < 8.0g/dl, ALT, AST or Scr exceeding 2 times the normal upper limit, and blood bilirubin exceeding 1.5 times the normal upper limit; 4) patients with severe and uncontrolled organic disease or infection, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy; 5) patients with severe bleeding tendency or bleeding disease; 6) patients with other primary malignancies within 5 years or currently; 7) mental illness, drug or alcohol abuse; 8) patients during pregnancy, lactation or pregnancy possibility or planned pregnancy; 9) allergy or allergy to this medicine; 10) have participated in or are participating in other clinical trials within the previous 3 months; 11) the researcher believes that there are any other ineligible conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Lung cancer - related quality of life scale (fact-l) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Time of disease progression (TTP);Objective response rate (ORR);TCM syndrome score; | — |
Countries
China
Contacts
Public ContactYingjie Jia
Outcome results
None listed