Squamous Cell Lung Cancer
Conditions
Interventions
treatment group:human recombinant human endostatin(endostar) injection combined with chemotheapy
control group:chemotheapy
Sponsors
The First Affiliated Hospital of Wannan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) squamous cell lung cancer patients; 2) According to IASLC2009 new TNM staging of lung cancer stage IIIB or IV NSCLC; 3) have at least one evaluable lesions,according to version 1.1 of the standard in accordance with a judgment RECIST(longest diameter on a spiral CT at least 10mm,on a regular CT longest diameter at least 20mm); 4) Male or female, aged 18 to 80 years; 5) ECOG PS 0 or 2; 6) expected survival at least 3 months; 7) adequate hematological function: absolute neutrophil count (ANC) at least 1.5×10^9/L and platelet count at least 80×10^9/L and hemoglobin at least 8 g/dL; 8) adequate liver function: total bilirubin less than 1.5 times upper limit of normal (ULN); AST and ALT less than 2.5 times upper limit of normal (ULN); alkaline phosphatase less than 5 times the upper limit of normal (ULN); 9) adequate renal function: serum creatinine less than 1.5 times upper limit of normal (ULN) or calculated creatinine clearance at least 45 mL/min; 10) ECG is normal, there is no non-healing wounds on the body; 11) had not received previous treatment anticancer drugs, or had only received for previous non-metastatic tumors adjuvant or neoadjuvant chemotherapy, but when you start to study treatment has ended more than 6 months; 12) have conducted previous surgery patients required to study treatment was started more than four weeks, and the patient had recovered; 13) have an intact uterus in women prior to enrollment in the study must have a negative pregnancy test result (unless it is already 24 months of amenorrhea) within 28 days. If the pregnancy test from the first administration more than seven days, urine pregnancy test is required for authentication (less than 7 days before the first dose); 14) previous to biological agents, particularly E.coli genetically engineered products without serious allergic reactions; 15) signed informed consent.
Exclusion criteria
Exclusion criteria: 1) pregnancy, breast-feeding women, or female patients of childbearing potential but did not take contraceptive measures; 2) existing severe acute infection and is not controlled; or purulent and chronic infection, delayed healing wounds; 3) the original severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 4) have bleeding tendencies; 5) other researchers believe that patients should not participate in the present trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS;Qol; | — |
Countries
China
Contacts
Public ContactZhiwei Lu
The First Affiliated of Wannan Medical College
Outcome results
None listed