non-small-cell lung carcinoma
Conditions
Interventions
Group 2:ystemic chemotherapy
Sponsors
The Fifth Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this study: 1. Volunteer to participate in clinical research and sign written informed consent. 2. The age is 18-75 years old, and there is no limit for men and women. 3. Patients with small cell lung cancer or non-small cell lung cancer who can not be operated on and can not receive radical concurrent radiotherapy and chemotherapy. 4. The tumor was divided into three to four stages and received immunotherapy and / or systemic anti-tumor chemotherapy. 5. Estimated survival time >= 3 months; 6. ECoG status score is 0-2; 7. Be able to provide high-throughput tumor gene detection reports including PD-L1 expression and tumor mutation load (TMB), or provide tumor tissue samples for flux tumor gene detection. 8. Organ function level must meet the following requirements: (1) hematology indexes: neutrophil absolute count >= 1.5 x 10^9 / L, platelet count >= 80 x 10^9 / L, hemoglobin >= 90 g / L; (2) liver function: total bilirubin = 60ml / min; (4) coagulation function: INR, Pt and APTT <= 1.5 times the upper limit of normal value; (5) ECG is basically normal. 9. The serum pregnancy test must be carried out within 3 days before the first administration and the result is negative. If having sex with a male partner who has not been sterilized, an acceptable and effective contraceptive method must be taken from the beginning of screening to 120 days after the last administration; if having sex with a female partner who has not been sterilized, it must be from the beginning of screening to 120 days after the last administration Adopt acceptable and effective contraceptive methods.)
Exclusion criteria
Exclusion criteria: Subjects are not eligible to participate in this study if they meet any of the following exclusion criteria: 1. The subjects had cancerous meningitis. 2. Subjects with active central nervous system (CNS) metastasis should be excluded. Subjects may participate in the study if their CNS metastasis is adequately treated and their neurological symptoms return to baseline at least 2 weeks prior to inclusion (except for residual signs or symptoms related to CNS treatment). 3. Subjects with active, known or suspected autoimmune diseases were excluded. Subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases without systemic treatment (e.g., vitiligo, psoriasis or alopecia), or who are not expected to recur without external triggers, may be selected. 4. Subjects who needed systemic corticosteroids (doses equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment. Subjects who used inhaled or topical corticosteroids, and subjects whose doses of corticosteroid replacement therapy were equivalent to > 10 mg prednisone / day, could participate in the study if there was no active autoimmune disease. 5. Have used anti-tumor vaccine or other anti-tumor drugs with immune stimulating effect before. 6. Have coagulation dysfunction or bleeding tendency, or have a history of thrombosis or bleeding disease; 7. Being treated with anticoagulation or thrombolysis; 8. There is an unhealed wound ulcer or fracture; 9. Positive HBsAg or HCAB indicates acute or chronic infection. 10. According to chest X-ray examination, sputum examination and clinical examination, active tuberculosis (TB) infection was judged. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than one year ago should also be excluded unless it is proved that the course and type of anti tuberculosis treatment used before are appropriate. 11. The original serious heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and stubborn hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TREM2;PD1;TIM3;SLAMF7;TNF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perforin;Granzyme;IFN; | — |
Countries
China
Contacts
Public ContactXi Huang
The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed