{
    "info": {
        "nct_id": "NCT03262948",
        "official_title": "The Randomized,Open, Multicenter Phase III Study to Compare the Effectiveness and Safety of Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin First-Line Therapy Advanced Non Small Cell Lung Cancer Squamous Cell Carcinoma",
        "inclusion_criteria": "* Accepted the purpose of the trial, the contents , the predicted efficacy, pharmacological effects and the full explanation of the risk and was understood that the subject had signed the informed consent.\n* Subjects had histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma and were documented; (must be provided without radiotherapy, fixed with formalin, paraffin At least 5 sheets of tumor tissue after embedding)\n* Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification)\n* Subjects who were palliative radiotherapy for bone lesions other than the chest were given the study drug according to CTCAE 4.03 toxicity ≤1\n* at least one measurable objective lesions according to RECIST1.1 standard\n* ECOG score ≤ 1\n* Expected survival time ≥ 3 months\n* Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study\n* ≥ 18 years old male and female\n* The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative before 24 hours of the start of chemotherapy\n* Women must be non-lactating\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* There is brain metastases;\n* The investigators believe that uncontrolled serious medical illnesses that affect the ability of subjects to receive research programs, such as severe medical illnesses, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;\n* Will hinder the understanding or make informed consent or fill in the questionnaire of dementia, mental state changes or any mental illness;\n* Any history of allergic or hypersensitivity to any treatment ingredient;\n* In the first 5 years of randomization, there were malignant tumors other than NSCLC, except for the treatment of basal cells or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ\n* Previously received treatment for advanced/metastatic NSCLC. Note: Allow chemotherapy and radiotherapy to be used as part of neoadjuvant/adjuvant therapy as long as the treatment has ended at least 12 months before the diagnosis of advanced or metastatic disease.\n* Received a taxane-based regimen as a neoadjuvant/adjuvant therapy for squamous cell carcinoma ;\n* Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;\n* Physical examination and laboratory test results are abnormal ANC：<1.5×109 / L； PLT：<100×109/L； Hb: <90g/L\n* Abnormal liver function is defined as:\n\nI) total bilirubin (TBil) level:> normal upper limit (ULN) 1.5 times; II) 2.5 times the rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN, and> 5 times ULN if liver metastases are present\n\n* Definition of renal dysfunction:\n\nSerum creatinine> ULN 1.5 times, or creatinine clearance <50ml/min\n\n* Coagulation function abnormal definition:\n\nInternational Standardization Ratio (INR)> 1.5 times the ULN, and prothrombin time (PT) or activated partial coagulation Blood enzyme time (aPTT)> ULN 1.5 times, unless the subject is receiving anticoagulant therapy\n\n* Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥ 1×103copy number / L of the subjects; if HBsAg positive, and peripheral blood HBV-DNA <1 × 103 copy number / L, if the researchers believe that the subjects in a stable phase of chronic hepatitis B and does not increase the risk of subjects, the subjects eligible to be selected\n* Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive\n* need to merge other anti-tumor drug treatment\n* Received any other test drug treatment or participated in another interventional clinical trial before 30 days of screening period;\n* Researchers think it is not suitable for enrolling.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Accepted the purpose of the trial, the contents , the predicted efficacy, pharmacological effects and the full explanation of the risk and was understood that the subject had signed the informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Accepted the purpose of the trial",
                    "criterion": "trial purpose acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the contents",
                    "criterion": "trial contents acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the predicted efficacy",
                    "criterion": "predicted efficacy acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pharmacological effects",
                    "criterion": "pharmacological effects acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the full explanation of the risk",
                    "criterion": "risk explanation acceptance",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "was understood that the subject had signed the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects had histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma and were documented; (must be provided without radiotherapy, fixed with formalin, paraffin At least 5 sheets of tumor tissue after embedding)",
            "criterions": [
                {
                    "exact_snippets": "histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma",
                    "criterion": "NSCLC type of squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histopathologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "without radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fixed with formalin",
                    "criterion": "tumor tissue fixation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "formalin"
                        }
                    ]
                },
                {
                    "exact_snippets": "paraffin At least 5 sheets of tumor tissue after embedding",
                    "criterion": "tumor tissue embedding",
                    "requirements": [
                        {
                            "requirement_type": "material",
                            "expected_value": "paraffin"
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "sheets"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification)",
            "criterions": [
                {
                    "exact_snippets": "Subjects were IIIB ... according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not suitable for radical surgery",
                    "criterion": "suitability for radical surgery",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not suitable for ... radiotherapy",
                    "criterion": "suitability for radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects were ... IV ... NSCLC",
                    "criterion": "NSCLC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects were ... recurrent NSCLC",
                    "criterion": "NSCLC recurrence",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who were palliative radiotherapy for bone lesions other than the chest were given the study drug according to CTCAE 4.03 toxicity ≤1",
            "criterions": [
                {
                    "exact_snippets": "palliative radiotherapy for bone lesions other than the chest",
                    "criterion": "palliative radiotherapy for bone lesions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "other than the chest"
                        }
                    ]
                },
                {
                    "exact_snippets": "CTCAE 4.03 toxicity ≤1",
                    "criterion": "CTCAE 4.03 toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* at least one measurable objective lesions according to RECIST1.1 standard",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable objective lesions according to RECIST1.1 standard",
                    "criterion": "measurable objective lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesions"
                            }
                        },
                        {
                            "requirement_type": "standard",
                            "expected_value": "RECIST1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG score ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG score ≤ 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival time ≥ 3 months",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time ≥ 3 months",
                    "criterion": "survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study",
            "criterions": [
                {
                    "exact_snippets": "Subjects are well-behaved",
                    "criterion": "behavior",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "well-behaved"
                        }
                    ]
                },
                {
                    "exact_snippets": "able to undergo treatment",
                    "criterion": "ability to undergo treatment",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "able to ... follow-up",
                    "criterion": "ability to follow-up",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily comply with this study",
                    "criterion": "voluntary compliance",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 18 years old male and female",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "male and female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed genders",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative before 24 hours of the start of chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "The childbearing age subjects",
                    "criterion": "childbearing age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to take effective contraceptive measures during the trial",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the serum or urine pregnancy test must be negative before 24 hours of the start of chemotherapy",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "before 24 hours of the start of chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must be non-lactating",
            "criterions": [
                {
                    "exact_snippets": "Women must be non-lactating",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "non-lactating"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* There is brain metastases;",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The investigators believe that uncontrolled serious medical illnesses that affect the ability of subjects to receive research programs, such as severe medical illnesses, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled serious medical illnesses",
                    "criterion": "uncontrolled serious medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe heart disease",
                    "criterion": "severe heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular disease",
                    "criterion": "cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diabetes",
                    "criterion": "uncontrolled diabetes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled high blood pressure",
                    "criterion": "uncontrolled high blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled infections",
                    "criterion": "uncontrolled infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active peptic ulcers",
                    "criterion": "active peptic ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Will hinder the understanding or make informed consent or fill in the questionnaire of dementia, mental state changes or any mental illness;",
            "criterions": [
                {
                    "exact_snippets": "dementia",
                    "criterion": "dementia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental state changes",
                    "criterion": "mental state changes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any history of allergic or hypersensitivity to any treatment ingredient;",
            "criterions": [
                {
                    "exact_snippets": "history of allergic or hypersensitivity to any treatment ingredient",
                    "criterion": "allergic or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In the first 5 years of randomization, there were malignant tumors other than NSCLC, except for the treatment of basal cells or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ",
            "criterions": [
                {
                    "exact_snippets": "malignant tumors other than NSCLC",
                    "criterion": "malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than NSCLC"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of basal cells or squamous cell skin cancer",
                    "criterion": "basal cells or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "localized prostate cancer after radical resection",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "after radical resection"
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previously received treatment for advanced/metastatic NSCLC. Note: Allow chemotherapy and radiotherapy to be used as part of neoadjuvant/adjuvant therapy as long as the treatment has ended at least 12 months before the diagnosis of advanced or metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Previously received treatment for advanced/metastatic NSCLC",
                    "criterion": "treatment for advanced/metastatic NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allow chemotherapy and radiotherapy to be used as part of neoadjuvant/adjuvant therapy",
                    "criterion": "chemotherapy and radiotherapy as neoadjuvant/adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment has ended at least 12 months before the diagnosis of advanced or metastatic disease",
                    "criterion": "time since neoadjuvant/adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received a taxane-based regimen as a neoadjuvant/adjuvant therapy for squamous cell carcinoma ;",
            "criterions": [
                {
                    "exact_snippets": "Received a taxane-based regimen as a neoadjuvant/adjuvant therapy",
                    "criterion": "taxane-based regimen",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;",
            "criterions": [
                {
                    "exact_snippets": "≥2 grade peripheral neuropathy according to CTCAE V 4.03",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Physical examination and laboratory test results are abnormal ANC：<1.5×109 / L； PLT：<100×109/L； Hb: <90g/L",
            "criterions": [
                {
                    "exact_snippets": "ANC：<1.5×109 / L",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PLT：<100×109/L",
                    "criterion": "PLT (Platelet Count)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hb: <90g/L",
                    "criterion": "Hb (Hemoglobin)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal liver function is defined as:",
            "criterions": [
                {
                    "exact_snippets": "Abnormal liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Definition of renal dysfunction:",
            "criterions": [
                {
                    "exact_snippets": "Definition of renal dysfunction",
                    "criterion": "renal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Serum creatinine> ULN 1.5 times, or creatinine clearance <50ml/min",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine> ULN 1.5 times",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance <50ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coagulation function abnormal definition:",
            "criterions": [
                {
                    "exact_snippets": "Coagulation function abnormal",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "International Standardization Ratio (INR)> 1.5 times the ULN, and prothrombin time (PT) or activated partial coagulation Blood enzyme time (aPTT)> ULN 1.5 times, unless the subject is receiving anticoagulant therapy",
            "criterions": [
                {
                    "exact_snippets": "International Standardization Ratio (INR)> 1.5 times the ULN",
                    "criterion": "International Standardization Ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times the ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time (PT) ... > ULN 1.5 times",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times the ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial coagulation Blood enzyme time (aPTT)> ULN 1.5 times",
                    "criterion": "activated partial coagulation Blood enzyme time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times the ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the subject is receiving anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥ 1×103copy number / L of the subjects; if HBsAg positive, and peripheral blood HBV-DNA <1 × 103 copy number / L, if the researchers believe that the subjects in a stable phase of chronic hepatitis B and does not increase the risk of subjects, the subjects eligible to be selected",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis B surface antigen positive (HBsAg)",
                    "criterion": "Hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥ 1×103copy number / L",
                    "criterion": "peripheral blood hepatitis B virus DNA titer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1000,
                                "unit": "copy number / L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HBsAg positive, and peripheral blood HBV-DNA <1 × 103 copy number / L",
                    "criterion": "peripheral blood hepatitis B virus DNA titer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1000,
                                "unit": "copy number / L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "researchers believe that the subjects in a stable phase of chronic hepatitis B",
                    "criterion": "stable phase of chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "researcher assessment",
                            "expected_value": "stable phase"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive",
            "criterions": [
                {
                    "exact_snippets": "Hepatitis C virus (HCV) antibody positive",
                    "criterion": "Hepatitis C virus (HCV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV) antibody positive",
                    "criterion": "human immunodeficiency virus (HIV) antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* need to merge other anti-tumor drug treatment",
            "criterions": [
                {
                    "exact_snippets": "merge other anti-tumor drug treatment",
                    "criterion": "anti-tumor drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "merge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received any other test drug treatment or participated in another interventional clinical trial before 30 days of screening period;",
            "criterions": [
                {
                    "exact_snippets": "Received any other test drug treatment",
                    "criterion": "test drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participated in another interventional clinical trial",
                    "criterion": "interventional clinical trial participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "before 30 days of screening period",
                    "criterion": "time since last participation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Researchers think it is not suitable for enrolling.",
            "criterions": [
                {
                    "exact_snippets": "Researchers think it is not suitable for enrolling.",
                    "criterion": "suitability for enrolling",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "not suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "I) total bilirubin (TBil) level:> normal upper limit (ULN) 1.5 times; II) 2.5 times the rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN, and> 5 times ULN if liver metastases are present",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin (TBil) level:> normal upper limit (ULN) 1.5 times",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN",
                    "criterion": "aspartate aminotransferase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN",
                    "criterion": "alanine aminotransferase level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> 5 times ULN if liver metastases are present",
                    "criterion": "aspartate aminotransferase level with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> 5 times ULN if liver metastases are present",
                    "criterion": "alanine aminotransferase level with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}