Non-small lung cancer cell
Conditions
Interventions
Sensitive group and insensitive group after TCM combined with PD-1 :None
Sponsors
LongHua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age is over 18 years old, male or female; (2) Patients with locally advanced or metastatic NSCLC diagnosed as stages III-IV by histology or cytology; (3) Meet the standard of TCM certificate type; (4) The subject had at least one measurable lesion according to the RECIST V1.1 criteria; (5) 4 cycles of PD-1 combined with TCM treatment; (6) ECOG PS score: 0-2 points; (7) The organ function level meets the following requirements (test results within 14 days before enrollment): ? Hematology parameters: absolute neutrophil count =1.5×10^9/L, platelet count =70×10^9/L, hemoglobin = 90 g/L; ? Liver function: =1.5 times the upper limit of normal value of total bilirubin, = 3 times the upper limit of normal value of glutamate transaminase and glutamate transaminase, If there is intrahepatic metastasis, transaminase = 5.0 times the upper limit of normal value; ? Renal function: creatinine is = 2.5 times the upper limit of the normal value;
Exclusion criteria
Exclusion criteria: (1) Lung cancer patients with small-cell lung carcinoma, mixed squamous gland carcinoma confirmed by histology or cytology, or containing neuroendocrine carcinoma; (2) Patients with driver gene mutations (including EGFR +, T790M +, ALK +, etc.); (3) any previous T-cell co-stimulatory or immune checkpoint therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 / 2 inhibitors, or other drugs targeting T cells; (4) Interstitial lung disease, drug-induced pneumonia, radiation pneumonia, or active pneumonia with clinical symptoms or severe pulmonary dysfunction; (5) the presence of any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, etc.); (6) Patients with a clear or suspected brain metastasis. Patients with a previous history of brain metastases who must have completed therapy and no longer need corticosteroid therapy can be enrolled; (7) For subjects with no measured lesions; (8) Poor general condition (a large amount of thoracic ascites requiring repeated drainage, severe infection, high fever), obvious cachexia, serious insufficiency of important organ function, severe anemia and nutritional metabolism disorders can not be improved in the short term; (9) Have various bleeding tendencies or blood coagulation dysfunction, or have a history of thrombosis or hemorrhagic disease; (10) Pregnant or lactating women; (11) Subjects with mental illness, alcohol abuse, inability to quit smoking, drug use, or drug abuse; (12) Patients who are not considered appropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactJia Yang
LongHua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed