{
    "info": {
        "nct_id": "NCT00238394",
        "official_title": "A Phase II Study of AZD2171 in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma",
        "inclusion_criteria": "* Histologically confirmed hepatocellular carcinoma\n\n  * Locally advanced or metastatic disease\n  * Not amenable to treatment with surgery or orthotopic liver transplantation\n* Measurable or non-measurable disease\n\n  * Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan\n* Evidence of disease progression by imaging on serial exams or biochemical evidence of a rising alpha fetoprotein on serial testing\n* No history of brain metastases other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery)\n\n  * Patients with locally treatable CNS disease eligible provided they were previously treated and had no evidence of CNS progression for ≥ 4 weeks after completion of treatment\n* No fibrolamellar hepatocellular carcinoma or mixed cholangiocarcinoma/hepatocellular carcinoma\n* Performance status - ECOG 0-1\n* Absolute neutrophil count ≥ 1,200/mm^3\n* Platelet count ≥ 75,000/mm^3\n* Hemoglobin ≥ 10.0 g/dL\n* Bilirubin ≤ 3 times upper limit of normal (ULN)\n* AST ≤ 5 times ULN\n* Alkaline phosphatase ≤ 5 times ULN\n* Urine protein < 1+ by urine dip stick OR proteinuria < 1 gm/24-hour collection\n* QTc prolongation ≤ 500 msec\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg\n* No significant ECG abnormality within the past 14 days\n* No New York Heart Association class III or IV disease\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study participation\n* No other uncontrolled illness\n* More than 4 weeks since prior biologic therapy\n* More than 4 weeks since prior and no concurrent immunotherapy\n* No colony-stimulating factors during the first course of study treatment\n* At least 6 weeks since prior chemoembolization\n\n  * Patients must have evidence of disease progression or new metastases after prior chemoembolization\n* No prior systemic chemotherapy for this cancer\n* No other concurrent chemotherapy\n* More than 4 weeks since prior hormonal therapy\n* See Disease Characteristics\n* At least 6 weeks since prior radiofrequency ablation or other local ablative therapy\n\n  * Patients must have evidence of disease progression or new metastases after prior radiofrequency ablation or other local ablative therapy\n* No prior external beam radiotherapy to the primary site\n* No prior radiotherapy to ≥ 25% of the bone marrow\n* No concurrent radiotherapy\n* See Disease Characteristics\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No concurrent drugs or biologics with proarrhythmic potential\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed hepatocellular carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed hepatocellular carcinoma",
                    "criterion": "hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced or metastatic disease",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not amenable to treatment with surgery or orthotopic liver transplantation",
            "criterions": [
                {
                    "exact_snippets": "Not amenable to treatment with surgery",
                    "criterion": "treatment with surgery",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not amenable to treatment with ... orthotopic liver transplantation",
                    "criterion": "treatment with orthotopic liver transplantation",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable or non-measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable or non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques",
                    "criterion": "unidimensionally measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "mm"
                            }
                        },
                        {
                            "requirement_type": "measurement technique",
                            "expected_value": "conventional techniques"
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease is defined as ... ≥ 10 mm by spiral CT scan",
                    "criterion": "unidimensionally measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        },
                        {
                            "requirement_type": "measurement technique",
                            "expected_value": "spiral CT scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of disease progression by imaging on serial exams or biochemical evidence of a rising alpha fetoprotein on serial testing",
            "criterions": [
                {
                    "exact_snippets": "Evidence of disease progression by imaging on serial exams",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "imaging on serial exams"
                        }
                    ]
                },
                {
                    "exact_snippets": "biochemical evidence of a rising alpha fetoprotein on serial testing",
                    "criterion": "alpha fetoprotein",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "biochemical"
                        },
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of brain metastases other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery)",
            "criterions": [
                {
                    "exact_snippets": "No history of brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other than locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery)",
                    "criterion": "CNS lesions",
                    "requirements": [
                        {
                            "requirement_type": "treatability",
                            "expected_value": [
                                "surgery",
                                "radiosurgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with locally treatable CNS disease eligible provided they were previously treated and had no evidence of CNS progression for ≥ 4 weeks after completion of treatment",
            "criterions": [
                {
                    "exact_snippets": "Patients with locally treatable CNS disease",
                    "criterion": "CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "treatability",
                            "expected_value": "locally treatable"
                        }
                    ]
                },
                {
                    "exact_snippets": "provided they were previously treated",
                    "criterion": "CNS disease treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "previously treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of CNS progression",
                    "criterion": "CNS progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "for ≥ 4 weeks after completion of treatment",
                    "criterion": "CNS progression",
                    "requirements": [
                        {
                            "requirement_type": "duration since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No fibrolamellar hepatocellular carcinoma or mixed cholangiocarcinoma/hepatocellular carcinoma",
            "criterions": [
                {
                    "exact_snippets": "No fibrolamellar hepatocellular carcinoma",
                    "criterion": "fibrolamellar hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... mixed cholangiocarcinoma/hepatocellular carcinoma",
                    "criterion": "mixed cholangiocarcinoma/hepatocellular carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status - ECOG 0-1",
            "criterions": [
                {
                    "exact_snippets": "Performance status - ECOG 0-1",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "ECOG score",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "ECOG"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "ECOG"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,200/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,200/mm^3",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1200,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 75,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 75,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 10.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 10.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin ≤ 3 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 3 times upper limit of normal (ULN)",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST ≤ 5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "AST ≤ 5 times ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase ≤ 5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase ≤ 5 times ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Urine protein < 1+ by urine dip stick OR proteinuria < 1 gm/24-hour collection",
            "criterions": [
                {
                    "exact_snippets": "Urine protein < 1+ by urine dip stick",
                    "criterion": "urine protein",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "+"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "proteinuria < 1 gm/24-hour collection",
                    "criterion": "proteinuria",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "gm/24-hour"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTc prolongation ≤ 500 msec",
            "criterions": [
                {
                    "exact_snippets": "QTc prolongation ≤ 500 msec",
                    "criterion": "QTc prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 500,
                                "unit": "msec"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No symptomatic congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "No symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unstable angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "No unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No cardiac arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "No cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled blood pressure, defined as systolic blood pressure > 150 mm Hg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 150,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled blood pressure, defined as ... diastolic blood pressure > 100 mm Hg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "controlled"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant ECG abnormality within the past 14 days",
            "criterions": [
                {
                    "exact_snippets": "No significant ECG abnormality within the past 14 days",
                    "criterion": "ECG abnormality",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not significant"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 14 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No New York Heart Association class III or IV disease",
            "criterions": [
                {
                    "exact_snippets": "No New York Heart Association class III or IV disease",
                    "criterion": "New York Heart Association class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 3,
                                "unit": "class"
                            }
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "!=",
                                "value": 4,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other malignancy within the past 5 years",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except basal cell or squamous cell skin cancer",
                    "criterion": "basal cell or squamous cell skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171",
            "criterions": [
                {
                    "exact_snippets": "No history of allergic reaction to compounds of similar chemical or biological composition to AZD2171",
                    "criterion": "allergic reaction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compound similarity",
                            "expected_value": "similar chemical or biological composition to AZD2171"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ongoing or active infection",
            "criterions": [
                {
                    "exact_snippets": "No ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No psychiatric illness or social situation that would preclude study participation",
            "criterions": [
                {
                    "exact_snippets": "No psychiatric illness",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... social situation that would preclude study participation",
                    "criterion": "social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other uncontrolled illness",
            "criterions": [
                {
                    "exact_snippets": "No other uncontrolled illness",
                    "criterion": "uncontrolled illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior biologic therapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior biologic therapy",
                    "criterion": "time since prior biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior and no concurrent immunotherapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since prior treatment",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "concurrent treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No colony-stimulating factors during the first course of study treatment",
            "criterions": [
                {
                    "exact_snippets": "No colony-stimulating factors during the first course of study treatment",
                    "criterion": "colony-stimulating factors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have evidence of disease progression or new metastases after prior chemoembolization",
            "criterions": [
                {
                    "exact_snippets": "evidence of disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "new metastases",
                    "criterion": "new metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior chemoembolization",
                    "criterion": "prior chemoembolization",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior systemic chemotherapy for this cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic chemotherapy for this cancer",
                    "criterion": "prior systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent chemotherapy",
                    "criterion": "concurrent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior hormonal therapy",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior hormonal therapy",
                    "criterion": "time since prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "refer to disease characteristics section"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 6 weeks since prior radiofrequency ablation or other local ablative therapy",
            "criterions": [
                {
                    "exact_snippets": "At least 6 weeks since prior radiofrequency ablation",
                    "criterion": "time since prior radiofrequency ablation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 6 weeks since prior ... other local ablative therapy",
                    "criterion": "time since prior local ablative therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have evidence of disease progression or new metastases after prior radiofrequency ablation or other local ablative therapy",
            "criterions": [
                {
                    "exact_snippets": "evidence of disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "new metastases",
                    "criterion": "new metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior radiofrequency ablation",
                    "criterion": "prior radiofrequency ablation",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other local ablative therapy",
                    "criterion": "other local ablative therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior external beam radiotherapy to the primary site",
            "criterions": [
                {
                    "exact_snippets": "No prior external beam radiotherapy to the primary site",
                    "criterion": "external beam radiotherapy to the primary site",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to ≥ 25% of the bone marrow",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to ≥ 25% of the bone marrow",
                    "criterion": "prior radiotherapy to bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No concurrent radiotherapy",
                    "criterion": "concurrent radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* See Disease Characteristics",
            "criterions": [
                {
                    "exact_snippets": "Disease Characteristics",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "see details"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent combination antiretroviral therapy for HIV-positive patients",
            "criterions": [
                {
                    "exact_snippets": "No concurrent combination antiretroviral therapy for HIV-positive patients",
                    "criterion": "combination antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent drugs or biologics with proarrhythmic potential",
            "criterions": [
                {
                    "exact_snippets": "No concurrent drugs or biologics with proarrhythmic potential",
                    "criterion": "concurrent drugs or biologics",
                    "requirements": [
                        {
                            "requirement_type": "proarrhythmic potential",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 6 weeks since prior chemoembolization",
            "criterions": [
                {
                    "exact_snippets": "at least 6 weeks since prior chemoembolization",
                    "criterion": "time since prior chemoembolization",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}