{
    "info": {
        "nct_id": "NCT02804646",
        "official_title": "Recombinant Human Endostatin Durative Transfusion Combined With Pemetrexed Plus Cisplatin or Carboplatin in the First-line Treatment of Advanced Lung Adenocarcinoma With Wild-type EGFR or ALK-negative",
        "inclusion_criteria": "* 1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) non-small cell lung cancer patients,with wild-type EGFR 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 at least 10mm,on a regular CT longest diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6) expected survival at least 3 months; 7) adequate hematological function: absolute neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than 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 upper limit of normal (ULN) or calculated creatinine clearance at least 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.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "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.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1) histologically confirmed (patients not receiving a single sputum cytology diagnosis) non-small cell lung cancer patients,with wild-type EGFR 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 at least 10mm,on a regular CT longest diameter at least 20mm); 4) Male or female, aged 18 to 75 years; 5) ECOG PS 0 or 1; 6) expected survival at least 3 months; 7) adequate hematological function: absolute neutrophil count (ANC) at least 2×10^9/L and platelet count at least 100×10^9/L and hemoglobin at least 9 g/dL; 8) adequate liver function: total bilirubin less than 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 upper limit of normal (ULN) or calculated creatinine clearance at least 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.",
            "criterions": [
                {
                    "exact_snippets": [
                        "histologically confirmed",
                        "non-small cell lung cancer"
                    ],
                    "criterion": "non-small cell lung cancer",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "wild-type EGFR"
                    ],
                    "criterion": "EGFR",
                    "requirement_type": "mutation status",
                    "expected_value": "wild-type"
                },
                {
                    "exact_snippets": [
                        "ALK-negative"
                    ],
                    "criterion": "ALK",
                    "requirement_type": "mutation status",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "IASLC2009 new TNM staging of lung cancer stage ⅢB or Ⅳ"
                    ],
                    "criterion": "TNM staging",
                    "requirement_type": "stage",
                    "expected_value": [
                        "ⅢB",
                        "Ⅳ"
                    ]
                },
                {
                    "exact_snippets": [
                        "previously untreated or relapsed after 1 year of lung cancer resection"
                    ],
                    "criterion": "treatment history",
                    "requirement_type": "status",
                    "expected_value": [
                        "previously untreated",
                        "relapsed after 1 year of lung cancer resection"
                    ]
                },
                {
                    "exact_snippets": [
                        "at least one evaluable lesions"
                    ],
                    "criterion": "evaluable lesions",
                    "requirement_type": "quantity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "RECIST",
                        "longest diameter on a spiral CT at least 10mm",
                        "on a regular CT longest diameter at least 20mm"
                    ],
                    "criterion": "lesion size",
                    "requirement_type": "measurement",
                    "expected_value": "RECIST 1.1 standards"
                },
                {
                    "exact_snippets": [
                        "Male or female, aged 18 to 75 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            },
                            {
                                "operator": "<=",
                                "value": 75
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "ECOG PS 0 or 1"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "score",
                    "expected_value": [
                        "0",
                        "1"
                    ]
                },
                {
                    "exact_snippets": [
                        "expected survival at least 3 months"
                    ],
                    "criterion": "expected survival",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">=",
                        "value": 3
                    }
                },
                {
                    "exact_snippets": [
                        "adequate hematological function",
                        "absolute neutrophil count (ANC) at least 2×10^9/L"
                    ],
                    "criterion": "absolute neutrophil count",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2000000000.0
                    }
                },
                {
                    "exact_snippets": [
                        "adequate hematological function",
                        "platelet count at least 100×10^9/L"
                    ],
                    "criterion": "platelet count",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">=",
                        "value": 100000000000.0
                    }
                },
                {
                    "exact_snippets": [
                        "adequate hematological function",
                        "hemoglobin at least 9 g/dL"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": ">=",
                        "value": 9
                    }
                },
                {
                    "exact_snippets": [
                        "adequate liver function",
                        "total bilirubin less than upper limit of normal (ULN)"
                    ],
                    "criterion": "total bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1
                    }
                },
                {
                    "exact_snippets": [
                        "adequate liver function",
                        "AST and ALT less than 2.5 times upper limit of normal (ULN)"
                    ],
                    "criterion": "AST and ALT",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "adequate liver function",
                        "alkaline phosphatase less than 5 times the upper limit of normal (ULN)"
                    ],
                    "criterion": "alkaline phosphatase",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 5
                    }
                },
                {
                    "exact_snippets": [
                        "adequate renal function",
                        "serum creatinine less than upper limit of normal (ULN)"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1
                    }
                },
                {
                    "exact_snippets": [
                        "adequate renal function",
                        "calculated creatinine clearance at least 60 mL/min"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "rate",
                    "expected_value": {
                        "operator": ">=",
                        "value": 60
                    }
                },
                {
                    "exact_snippets": [
                        "ECG is normal"
                    ],
                    "criterion": "ECG",
                    "requirement_type": "status",
                    "expected_value": "normal"
                },
                {
                    "exact_snippets": [
                        "no non-healing wounds on the body"
                    ],
                    "criterion": "non-healing wounds",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "had not received previous treatment anticancer drugs",
                        "only received for previous non-metastatic tumors adjuvant or neoadjuvant chemotherapy",
                        "treatment has ended more than 6 months"
                    ],
                    "criterion": "previous anticancer drug treatment",
                    "requirement_type": "history",
                    "expected_value": "none or ended >6 months ago"
                },
                {
                    "exact_snippets": [
                        "previous surgery patients required to study treatment was started more than four weeks",
                        "patient had recovered"
                    ],
                    "criterion": "previous surgery",
                    "requirement_type": "recovery",
                    "expected_value": "recovered >4 weeks ago"
                },
                {
                    "exact_snippets": [
                        "intact uterus in women",
                        "negative pregnancy test result",
                        "within 28 days"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative within 28 days"
                },
                {
                    "exact_snippets": [
                        "previous to biological agents",
                        "E.coli genetically engineered products without serious allergic reactions"
                    ],
                    "criterion": "allergic reactions to biological agents",
                    "requirement_type": "history",
                    "expected_value": "none"
                },
                {
                    "exact_snippets": [
                        "signed informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 75 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 75
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 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.",
            "criterions": [
                {
                    "exact_snippets": [
                        "pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "breast-feeding women"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "female patients of childbearing potential",
                        "did not take contraceptive measures"
                    ],
                    "criterion": "contraceptive measures",
                    "requirement_type": "usage",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "existing severe acute infection",
                        "is not controlled"
                    ],
                    "criterion": "severe acute infection",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "purulent and chronic infection"
                    ],
                    "criterion": "purulent and chronic infection",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "delayed healing wounds"
                    ],
                    "criterion": "delayed healing wounds",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "original severe heart disease"
                    ],
                    "criterion": "severe heart disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "uncontrolled high-risk arrhythmias"
                    ],
                    "criterion": "high-risk arrhythmias",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "unstable angina"
                    ],
                    "criterion": "unstable angina",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "myocardial infarction"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "severe heart valve disease"
                    ],
                    "criterion": "severe heart valve disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "resistant hypertension"
                    ],
                    "criterion": "resistant hypertension",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "suffering from neurological and psychiatric diseases",
                        "is not easy to control"
                    ],
                    "criterion": "neurological and psychiatric diseases",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "mental disorders",
                        "is not easy to control"
                    ],
                    "criterion": "mental disorders",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "poor compliance"
                    ],
                    "criterion": "compliance",
                    "requirement_type": "quality",
                    "expected_value": "poor"
                },
                {
                    "exact_snippets": [
                        "primary brain or central nervous metastasis disease",
                        "has not been controlled"
                    ],
                    "criterion": "brain or central nervous metastasis disease",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "significant cranial hypertension"
                    ],
                    "criterion": "cranial hypertension",
                    "requirement_type": "severity",
                    "expected_value": "significant"
                },
                {
                    "exact_snippets": [
                        "neuropsychiatric symptoms"
                    ],
                    "criterion": "neuropsychiatric symptoms",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "bleeding tendencies"
                    ],
                    "criterion": "bleeding tendencies",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other researchers believe that patients should not participate"
                    ],
                    "criterion": "researcher opinion",
                    "requirement_type": "participation recommendation",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}