Non-small cell lung cancer
Conditions
Interventions
Sponsors
Xuzhou Medical College Affiliated Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. ECOG function status score 0-1 points; 3. Stage IV primary non-small cell lung cancer diagnosed by histopathology; 4. Genetic testing indicates that the driver genes including EGFR, ALK, and ROS-1 are all negative; 5. The patient progresses after first-line anti-tumor treatment, and the first-line treatment must include a platinum-containing combination chemotherapy, but cannot include anti-PD-1/L1 therapy; 6. Patients with brain metastases can be included, but they must have no neurological symptoms and stable lesions without receiving systemic glucocorticoid therapy; 7. If the subject has undergone surgery, he must fully recover from the toxicity and complications of the surgical intervention before starting treatment; 8. Males/females of childbearing age agree to contraception during the trial period (surgical ligation or oral contraceptives/intrauterine contraceptives + condoms for contraception); 9. Life expectancy >= 3 months; 10. One week before admission, the organ function level reached the following standards: 11. Bone marrow function: hemoglobin >= 80g/L, white blood cell count >= 4.0x10^9/L or neutrophil count >=1.5x10^9/L, platelet count >=100x10^9/L; 12. Liver: Serum total bilirubin level 1.5 times the upper limit of normal, the direct bilirubin level must be =50ml/min, urea nitrogen = 30g/L; 14. The patient must have the ability to understand and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Urine routine shows positive protein++; 3. Abnormal blood coagulation function and bleeding tendency: for example, there are active ulcer foci, fecal occult blood (++), etc.; 4. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study by the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Disease-free time;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactHan Zhengxiang
Xuzhou Medical College Affiliated Hospital
Outcome results
None listed