{
    "info": {
        "nct_id": "NCT00183885",
        "official_title": "A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C",
        "inclusion_criteria": "* Unresectable, histologically confirmed hepatocellular carcinoma with evident disease limited to liver.\n* Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed. The requirement for biopsy may be waived if alpha-fetoprotein is greater than 500 ng/mL and in the investigators opinion not explained by a concurrent hepatic inflammatory process.\n* Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.\n* Patients must have measurable disease. If prior radiation therapy was administered, measurable disease must be outside the radiation field.\n* Patients must have a Zubrod performance status of 0-2.\n* Patients must have a predicted life expectancy of at least 12 weeks.\n* Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of greater than or equal to 1,500/mm3, a hemoglobin level of greater than or equal to 9 gm/dl, and platelet count greater than or equal to 50,000/mm3. The granulocyte requirement may be waived if in the investigator's opinion the lower count reflects hypersplenism with adequate bone marrow reserves.\n* Patients must have adequate renal function as documented by a calculated creatinine clearance ≥ 60.\n* Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2x the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor. Patients may not have ascites or the ascites must be responsive to diuretics.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have received prior chemotherapy for unresectable disease\n* Patients with any active or uncontrolled infection, including known HIV infection. (Patients with active hepatitis B will be placed on lamivudine. Patients with active hepatitis C will be eligible if liver tests qualify (5.1.9)\n* Patients with psychiatric disorders that would interfere with consent or follow-up. Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n* Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Unresectable, histologically confirmed hepatocellular carcinoma with evident disease limited to liver.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Unresectable"
                    ],
                    "criterion": "hepatocellular carcinoma",
                    "requirement_type": "resectability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "histologically confirmed"
                    ],
                    "criterion": "hepatocellular carcinoma",
                    "requirement_type": "confirmation method",
                    "expected_value": "histological"
                },
                {
                    "exact_snippets": [
                        "evident disease"
                    ],
                    "criterion": "hepatocellular carcinoma",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "limited to liver"
                    ],
                    "criterion": "disease location",
                    "requirement_type": "location",
                    "expected_value": "liver"
                }
            ]
        },
        {
            "line": "* Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed. The requirement for biopsy may be waived if alpha-fetoprotein is greater than 500 ng/mL and in the investigators opinion not explained by a concurrent hepatic inflammatory process.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Tissue from tumor must be available"
                    ],
                    "criterion": "tumor tissue",
                    "requirement_type": "availability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "alpha-fetoprotein is greater than 500 ng/mL"
                    ],
                    "criterion": "alpha-fetoprotein",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 500
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must agree to have a 20 cc blood sample drawn"
                    ],
                    "criterion": "blood sample",
                    "requirement_type": "volume",
                    "expected_value": {
                        "operator": "=",
                        "value": 20
                    }
                },
                {
                    "exact_snippets": [
                        "Patients must agree to have a 20 cc blood sample drawn"
                    ],
                    "criterion": "blood sample",
                    "requirement_type": "agreement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "in addition to routine labs"
                    ],
                    "criterion": "routine labs",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "with each cycle of chemotherapy"
                    ],
                    "criterion": "chemotherapy cycle",
                    "requirement_type": "association",
                    "expected_value": "blood sample and routine labs"
                }
            ]
        },
        {
            "line": "* Patients must have measurable disease. If prior radiation therapy was administered, measurable disease must be outside the radiation field.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must have measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "If prior radiation therapy was administered, measurable disease must be outside the radiation field"
                    ],
                    "criterion": "measurable disease",
                    "requirement_type": "location",
                    "expected_value": "outside the radiation field"
                }
            ]
        },
        {
            "line": "* Patients must have a Zubrod performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Zubrod performance status of 0-2"
                    ],
                    "criterion": "Zubrod performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients must have a predicted life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": [
                        "predicted life expectancy",
                        "at least 12 weeks"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "minimum duration",
                    "expected_value": ">= 12 weeks"
                }
            ]
        },
        {
            "line": "* Patients must have a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of greater than or equal to 1,500/mm3, a hemoglobin level of greater than or equal to 9 gm/dl, and platelet count greater than or equal to 50,000/mm3. The granulocyte requirement may be waived if in the investigator's opinion the lower count reflects hypersplenism with adequate bone marrow reserves.",
            "criterions": [
                {
                    "exact_snippets": [
                        "pre-treatment granulocyte count",
                        "greater than or equal to 1,500/mm3"
                    ],
                    "criterion": "granulocyte count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1500
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "hemoglobin level",
                        "greater than or equal to 9 gm/dl"
                    ],
                    "criterion": "hemoglobin level",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 9
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "platelet count",
                        "greater than or equal to 50,000/mm3"
                    ],
                    "criterion": "platelet count",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 50000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients must have adequate renal function as documented by a calculated creatinine clearance ≥ 60.",
            "criterions": [
                {
                    "exact_snippets": [
                        "adequate renal function",
                        "calculated creatinine clearance ≥ 60"
                    ],
                    "criterion": "renal function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "calculated creatinine clearance ≥ 60"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "calculation",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 60
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2x the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor. Patients may not have ascites or the ascites must be responsive to diuretics.",
            "criterions": [
                {
                    "exact_snippets": [
                        "adequate hepatic function"
                    ],
                    "criterion": "hepatic function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "serum bilirubin less than or equal to 2x the institutional upper limit of normal"
                    ],
                    "criterion": "serum bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Patients may not have ascites"
                    ],
                    "criterion": "ascites",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "ascites must be responsive to diuretics"
                    ],
                    "criterion": "ascites",
                    "requirement_type": "responsiveness to diuretics",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who have received prior chemotherapy for unresectable disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "received prior chemotherapy"
                    ],
                    "criterion": "prior chemotherapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unresectable disease"
                    ],
                    "criterion": "disease resectability",
                    "requirement_type": "status",
                    "expected_value": "unresectable"
                }
            ]
        },
        {
            "line": "* Patients with any active or uncontrolled infection, including known HIV infection. (Patients with active hepatitis B will be placed on lamivudine. Patients with active hepatitis C will be eligible if liver tests qualify (5.1.9)",
            "criterions": [
                {
                    "exact_snippets": [
                        "any active or uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "status",
                    "expected_value": "active or uncontrolled"
                },
                {
                    "exact_snippets": [
                        "known HIV infection"
                    ],
                    "criterion": "HIV infection",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "active hepatitis B"
                    ],
                    "criterion": "hepatitis B",
                    "requirement_type": "status",
                    "expected_value": "active"
                },
                {
                    "exact_snippets": [
                        "active hepatitis C"
                    ],
                    "criterion": "hepatitis C",
                    "requirement_type": "status",
                    "expected_value": "active"
                },
                {
                    "exact_snippets": [
                        "liver tests qualify"
                    ],
                    "criterion": "liver tests",
                    "requirement_type": "qualification",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with psychiatric disorders that would interfere with consent or follow-up. Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.",
            "criterions": [
                {
                    "exact_snippets": [
                        "psychiatric disorders that would interfere with consent or follow-up"
                    ],
                    "criterion": "psychiatric disorders",
                    "requirement_type": "interference with consent or follow-up",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactating women"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Men and women of reproductive potential",
                        "agreed to use an effective contraceptive method"
                    ],
                    "criterion": "contraceptive method",
                    "requirement_type": "agreement to use",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "any other severe concurrent disease"
                    ],
                    "criterion": "severe concurrent disease",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}