phase ib/iia studies of chlorogenic acid for injection for safety and efficacy of advanced lung cancer

Conditions: Advanced Lung Cancer

Summary: this ib / iia clinical trial program focuses on the small cell lung cancer (sclc), squamous non-small cell lung cancer (nsclc) and adeniform nsclc in order to start a better development on the broad-spectrum value of chlorogenic acid： determine the disease control rate（dcr）of phase ib/iia of chlorogenic acid for injection in the advanced lung cancer patients.

1. determine the disease control rate（dcr）of chlorogenic acid for injection in the advanced lung cancer patients; 2. determine the overall survival（os）of chlorogenic acid for injection in the advanced lung cancer patients; 3. determine the objective response rate（orr）of chlorogenic acid for injection in the advanced lung cancer patients; 4. determine the progression free survival（pfs）of chlorogenic acid for injection in the advanced lung cancer patients; 5. determine eastern cooperative oncology group（ecog）.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18; 2. recurrent small cell lung cancer (sclc), squamous non-small cell lung cancer (nsclc) and adeniform nsclc; 3. estimated lifetime ≥ 3 months； 4. patients who have sufficient baseline organ function and whose laboratory data can meet the following criteria at the enrollment:1)plt count≥80×10\~9/l； 2)neut# count≥1.5×10\~9/l ；3)hgb count≥90g/l；4)total bilirubin \<=1.5 times of uln；5)alt/ast ≤2.5 times of uln； 5. female patients with negative pregnant test, and male/female patients of reproductive age without pregnancy planning in the next 12 months; 6. volunteered for the phase 1 trial and sign the informed consent without protest. exclusion criteria: 1. patients who suffer from other serious complication, such as uncontrollable infection, myocardial infarction within the past 6 months at the enrollment , uncontrollable hypertension ,thromboembolism and etc.; 2. patients with brain metastases; 3. patients with bone metastases; 4. patients who have primary immunodeficiency; 5. organ transplanters recipients; 6. patients who have received the therapy of chemotherapy within 4 weeks or radical radiotherapy with in 6 weeks before enrollment; 7. pregnant or breast-feeding women, or patients(male and female) who have pregnancy plan; 8. patients who had received a therapy of another investigational drug within 1 month； 9. known active hepatitis b/hepatitis c, positive hiv/ syphilis antibody; 10. patients who have received therapy of major surgery within 6 weeks or biopsy surgery within 2 weeks before enrollment; 11. patient who need long term treatment of cortical hormone or other immunosuppressive drugs such as visceral organ transplanters； 12. patients who have used nitrosoureas drug or mitomycin within 6 weeks or tyrosine kinase inhibitor within 2 weeks before enrollment; 13. patients who or have received radical radiotherapy within 6 weeks or local palliative radiotherapy within 2 weeks before enrollment; 14. history of drug abuse； 15. patients who was treated with immunologic drugs in 3 months; 16. other patients judged ineligible for enrollment in the study by the investigator (sub-investigator).