non-small lung cancer cell, NSCLC
Conditions
Interventions
control group (PD-1 inhibitors ± chemotherapy):None
observation group (SLBZ combined PD-1 inhibitors ± chemotherapy):None
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.met the diagnostic criteria of primary NSCLC and were diagnosed as lung adenocarcinoma, squamous cell carcinoma by pathology or cytology, TNM stage III-IV, without EGFR/ALK mutation, and receive PD-1 inhibitors ± chemotherapy firstly; 2.aged 18-75 years old, male or female; 3.TCM syndrome differentiation belongs to symptoms of lung-spleen deficiency; 4.at least one measurable lesion according to the efficacy evaluation standard of RECIST 1.1; 5.KPS score >=60 points, estimated survival >=3 months; 6.no oral/intravenous use of antibiotics within 2 months prior to enrollment, no oral/intravenous use of PPI or oral use of probiotics within 1 month; 7.without major organ dysfunction; 8.Volunteer to participate in clinical research and sign informed consent.
Exclusion criteria
Exclusion criteria: 1.combined with any other primary malignant tumors; 2. receiving concurrent radiotherapy, targeted therapy or anti angiogenic therapy; 3.pregnant or lactating patients, or combined severe heart, brain, liver, kidney, hematopoietic system diseases, as well as mental illnesses; 4.combined autoimmune diseases such as pulmonary sarcoidosis, ulcerative colitis, Crohn's disease, myasthenia gravis, etc., or being infected with HIV, or having a history of organ transplantation or stem cell transplantation surgery; 5.participated in other clinical trials which may affect the results of this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival(advanced patients);Disease-free survival(surgical patients); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Chinese medicine symptom score;quality of life;Immune indicators (T cell subset and related cytokine);Pathologic response rate(surgical patients);Tumor tissue T lymphocyte infiltration (surgical patients);Intestinal flora;Plasma metabolites; | — |
Countries
China
Contacts
Public ContactCuiling Feng
Peking University People's Hospital
Outcome results
None listed