advanced lung adenocarcinoma
Conditions
Interventions
advanced lung adenocarcinoma with EGFR wild-type or ALK-negative:recombinant human endostatin durative transfusion combined with pemetrexed plus cisplatin or carboplatin
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) non-small cell lung cancer patients,with EGFR wild-type and ALK-negative; 2) According to IASLC2009 new TNM staging of lung cancer stage IIIB or IV, previously untreated or relapsed after 1 year of lung cancer resection; 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 least 10mm, at least on a regular CT longest diameter 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 ~ 1 minute; 6) expected survival >=3 months; 7) adequate hematological function: absolute neutrophil count (ANC) >=2×10^9/L and platelet count >=100×10^9/L and hemoglobin >=9 g/dL; 8) adequate liver function: total bilirubin = upper limit of normal (ULN); AST and ALT=2.5 times upper limit of normal (ULN); alkaline phosphatase =5 times the upper limit of normal (ULN); 9) adequate renal function: serum creatinine = upper limit of normal (ULN) or calculated creatinine clearance =60 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) suffering from neurological and psychiatric diseases or mental disorders is not easy to control, poor compliance, and can not be described with treatment responders; primary brain or central nervous metastasis disease has not been controlled, with significant cranial hypertension or neuropsychiatric symptoms; 5) have bleeding tendencies; 6) other researchers believe that patients should not participate in the present trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China
Contacts
Public ContactLejie Cao
Anhui Provincial Hospital
Outcome results
None listed