NSCLC
Conditions
Interventions
trial group:NP+rh-Apo2L
control group:NP+placebo
Sponsors
General Hospital of Nanjing military region, Fuzhou, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Eligible patients had cytologically or histologically comfirmed advanced (stage IIIB or stage IV) or advanced NSCLC. The patients contain: initial treatment; recurrent NSCLC after surgery; recurrent NSCLC(>=6 months) after surgery with Chemotherapy, radiotherapy or molecular targeted therapy; 2. Measurable lesions in line with the requirement of RECIST, or part of unmeasurable lesions including: few-middle pleural effusion, pericardial effusion and bone metastases, Confirmed by pathology of lymph nodes( short diameter 10-15mm); 3. Eastern Cooperative Oncology Group performance status =3.5×10^9/L; (2) ANC>=1.5×10^9/L; (3) PLT>=80×10^9/L; (4) Hb>=80g/L; Blood biochemistry examination should meet the following criteria: (1) TBIL60ml/min(Cockcroft-Gault); 6. Complete the imaging examination related to tumor curative effect evaluation within two weeks of enrollment, complete the clinical evaluation, the blood, urinary and stool routine test, OB, blood biochemistry, EKG and CEA with one week of enrollment; 7. understanding the purpose of clinical trials, willing to participation and sign ICF; 8. Willingness and capability to be accessible for study follow-up; 9. For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial.
Exclusion criteria
Exclusion criteria: 1. women during pregnancy or lactation; 2. There was a clear history of allergies to biological products seriously; 3. Patients who had taken the NP chemotherapy within 1 year of enrollment; 4. The only lesions which can not be measured and shifted widely up to affect the survival of the patients significantly, included: extensive bone metastases, pia mater metastatic lesions, ascites, a large number of pleural effusion and pericardial effusion, skin lymphatic metastasis, diffuse lung lymphangitis, abdominal mass and cystic lesion which cannot be confirmed by imaging methods and follow-up; 5. Patients with mental illness or mental disorders that can result in poor compliance, incompatibility and unresponse to treatment; 6. The primary brain tumor or central nervous system metastases had not been controlled; Central nervous system tumors after treatment is still associated with cerebral hypertension or nerve mental symptoms; 7. Acute and chronic infections had not been eliminated in patients; 8. Patients who had serious organic disease or major organ failure, such as decompensated heart and lung function failure not to tolerate chemotherapy; 9. Patients with persistent bradycardia and positive atropine test; 10. Patients with a tendency to hemorrhage disease; 11. Transplants; 12. Patients with addiction to drugs such as narcotics, chronic alcoholics and infectious diseases such as HIV/AIDS; 13. Patients in other clinical trials at the same time; or in the clinical experiment in 3 months; 14. Patients with the long-term use of adrenal cortical hormone or immunosuppressants; 15. Other malignant tumors in five years (in addition to the cured skin basal cell carcinoma and the cervical carcinoma); 16. Patients with active hepatitis or liver tumor metastasis for more than three-quarters.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PF; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;Clinical symptom remission rate;safety; | — |
Countries
China
Contacts
Public ContactOUYANG XUENONG
Fuzhou General Hospital of Nanjing military region, PLA
Outcome results
None listed