Non-small cell lung cancer
Conditions
Interventions
Experiment group:SBRT,Toripalimab,Anlotinib,Albumin bound paclitaxel,probiotics,traditional Chinese medicine,GM-CSF
Sponsors
Fuzhou Pulmonary Hospital of fujian
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. = 18 years old and = 75 years old, male or female; 2. Locally advanced or metastatic non-small cell lung cancer confirmed by histology or pathology; 3. According to RECIST v1.1 standard, there is at least one measurable lesion; 4. Molecular pathology confirmed that there was no sensitive gene mutation (EGFR / ALK / ROS) 5. Patients who had not previously undergone systemic chemotherapy for locally advanced or metastatic non-small cell lung cancer can also be enrolled if they had previously undergone neoadjuvant or adjuvant treatment; 6. The ECoG PS score of Eastern cancer cooperation group was 0-1; 7. Expected survival period = 3 months; 8. Women of childbearing age must carry out serum pregnancy study within 2 weeks before the first medication, and the results are negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must contraception during the study period and within 180 days after the last administration of the study drug; 9. The laboratory test value of patients before medication should meet the following standards: 1) blood routine: WBC = 3.0 × 10^9/L ANC=1.5 × 10^9/L PLT=90 × 10^9/L; HGB=9.0 g/dL; 2) Liver function: TBIL = 1.5 × ULN,AST=2.5 × ULN,ALT=2.5 × ULN (AST = 5 for subjects with liver metastasis × ULN,ALT=5 × ULN); 3) Renal function: Cr = 1.5 × ULN or CrCl = 50 ml / min; 4) Coagulation function: INR = 1.5, APTT = 1.5 × ULN; 10. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: Subjects will not be allowed to enter the study if they meet any of the following conditions: 1. Small cell lung cancer confirmed by tumor histology or cytological pathology; 2. Patients with central squamous cell carcinoma must undergo CTA examination. Patients with primary and secondary bronchial artery blood supply in the tumor are at high risk of bleeding and are not included in this study; 3. Have previously received any T cell co stimulation or immune checkpoint therapy, including but not limited to CTLA-4 inhibitor, PD-1 inhibitor, PD-L1 / 2 inhibitor or other drugs targeting T cells; 4. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 5. Previous or current history of other cancers other than NSCLC, except for non melanoma skin cancer, cervical cancer in situ or other cancers that have received curative treatment and have no signs of recurrence for at least 5 years; 6. Uncontrolled hypertension with standard treatment (blood pressure not stable below 150 / 90 mmHg) 7. Hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, and stool occult blood + + and above in the baseline period; 8. Patients with definite or suspected brain metastasis. Patients with a previous history of brain metastasis must have completed treatment and no longer need corticosteroid treatment can be included in the group; For asymptomatic patients with brain metastases with the number of lesions = 3 and a single lesion less than 10mm, the investigator shall determine whether to enter the group; 9. There are cardiac clinical symptoms or diseases that cannot be well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 24 weeks (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 10. Patients with clinically uncontrollable third space effusion (such as pleural effusion / pericardial effusion, no need to drain effusion or no significant increase in effusion for 3 days after stopping drainage) can be enrolled in the group; 11. Those whose imaging (CT or MRI) shows that the tumor invades large blood vessels or those whose researchers judge that the tumor is likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study; 12. Have a history of immune deficiency, including HIV test positive, or have other acquired and congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 13. Patients with active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] test results are positive and HBV-DNA test value is higher than the upper limit of the normal value of the laboratory department of the research center) or hepatitis C (defined as hepatitis C virus surface antibody [hcsab] test results are positive and HCV-RNA is positive); 14. Those who have allergic reaction to the test drug applied; 15. In the judgment of the investigator, the subject has other factors that may lead to the forced termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Safety;One-year survival rate;ORR; | — |
Countries
China
Contacts
Public ContactQin Shi
Fuzhou Pulmonary Hospital of fujian
Outcome results
None listed