{
    "info": {
        "nct_id": "NCT01832948",
        "official_title": "Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction",
        "inclusion_criteria": "* Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)\n* At least one measurable lesion (RECIST criteria)\n* Life expectancy ≥ 3 months\n* ECOG performance status 0-2\n* Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L\n* Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min\n* Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN\n* Patients have not previously received palliative chemotherapy, immunological/ biological treatment\n* No adjuvant chemotherapy in last six months\n* Target lesion has not received local radiotherapy\n* Written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma\n* Evidence of serious or uncontrolled infection\n* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)\n* Pregnant or lactating women\n* Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy\n* Allergic to any of the study drug\n* Intestinal obstruction, intestinal perforation, or stroke within 3 months\n* Participation in other clinical studies",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic colorectal cancer (adenocarcinoma)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic colorectal cancer (adenocarcinoma)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one measurable lesion (RECIST criteria)",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion (RECIST criteria)",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic function: ANC ≥ 1.5×109 /L",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function: ... Hb ≥ 90 g/L",
                    "criterion": "Hb",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate hematologic function: ... PLT ≥ 100×109 /L",
                    "criterion": "PLT",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function: Cr ≤ 1.25×ULN",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.25,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance ≥ 60 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "clearance rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic function: BIL ≤ 1.5×ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT/AST ≤ 2.5×ULN",
                    "criterion": "ALT/AST levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 5×ULN",
                    "criterion": "alkaline phosphatase level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients have not previously received palliative chemotherapy, immunological/ biological treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients have not previously received palliative chemotherapy",
                    "criterion": "palliative chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients have not previously received ... immunological/ biological treatment",
                    "criterion": "immunological/ biological treatment",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No adjuvant chemotherapy in last six months",
            "criterions": [
                {
                    "exact_snippets": "No adjuvant chemotherapy in last six months",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Target lesion has not received local radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Target lesion has not received local radiotherapy",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "not received local radiotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of colorectal neuroendocrine tumor",
                    "criterion": "colorectal neuroendocrine tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... undifferentiated carcinoma",
                    "criterion": "undifferentiated carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... adenosquamous carcinoma",
                    "criterion": "adenosquamous carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of ... squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of serious or uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "serious or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)",
            "criterions": [
                {
                    "exact_snippets": "Serious cardiovascular disease (congestive heart failure ...",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious cardiovascular disease (... uncontrollable arrhythmia ...",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious cardiovascular disease (... unstable angina ...",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious cardiovascular disease (... myocardial infarction ...",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious cardiovascular disease (... serious heart valve disease ...",
                    "criterion": "heart valve disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious cardiovascular disease (... resistant hypertension)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": "resistant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refused to practice acceptable methods of birth control",
                    "criterion": "birth control practice",
                    "requirements": [
                        {
                            "requirement_type": "practice",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergic to any of the study drug",
            "criterions": [
                {
                    "exact_snippets": "Allergic to any of the study drug",
                    "criterion": "allergy to study drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intestinal obstruction, intestinal perforation, or stroke within 3 months",
            "criterions": [
                {
                    "exact_snippets": "Intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal perforation",
                    "criterion": "intestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke within 3 months",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participation in other clinical studies",
            "criterions": [
                {
                    "exact_snippets": "Participation in other clinical studies",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}