{
    "info": {
        "nct_id": "NCT00906373",
        "official_title": "A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)",
        "inclusion_criteria": "* The participant has histologically or cytologically confirmed, unresectable HCC\n* The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion\n* The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery\n* The participant has fasting serum glucose <160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN) and/or hemoglobin A1C <7%. If baseline nonfasting glucose <160 mg/dL, fasting glucose measurement is not required\n* The participant has the ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The participant has brain metastases\n* The participant has acute hepatitis\n* The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition\n* The participant has congestive heart failure > class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy\n* The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The participant has histologically or cytologically confirmed, unresectable HCC",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "HCC confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable HCC",
                    "criterion": "HCC resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion",
            "criterions": [
                {
                    "exact_snippets": "at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST guidelines"
                        }
                    ]
                },
                {
                    "exact_snippets": "Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area",
                    "criterion": "target lesion location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "not irradiated",
                                "not ablated",
                                "not chemoembolized"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity",
                    "criterion": "lesion growth evidence",
                    "requirements": [
                        {
                            "requirement_type": "growth evidence",
                            "expected_value": "successive imaging studies including tumor hypervascularity"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery",
            "criterions": [
                {
                    "exact_snippets": "The participant has not received prior systemic therapy for HCC.",
                    "criterion": "prior systemic therapy for HCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery",
                    "criterion": "prior treatments",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "embolization",
                                "chemoembolization",
                                "intra-arterial chemotherapy infusion",
                                "ethanol injection",
                                "radiofrequency ablation",
                                "cryosurgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has fasting serum glucose <160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN) and/or hemoglobin A1C <7%. If baseline nonfasting glucose <160 mg/dL, fasting glucose measurement is not required",
            "criterions": [
                {
                    "exact_snippets": "fasting serum glucose <160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN)",
                    "criterion": "fasting serum glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 160,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "level",
                            "expected_value": "below the upper limit of normal (ULN)"
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin A1C <7%",
                    "criterion": "hemoglobin A1C",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 7,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline nonfasting glucose <160 mg/dL",
                    "criterion": "baseline nonfasting glucose",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 160,
                                        "unit": "mg/dL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has the ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "The participant has the ability to understand",
                    "criterion": "ability to understand",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the willingness to sign a written informed consent document",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* The participant has brain metastases",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has acute hepatitis",
            "criterions": [
                {
                    "exact_snippets": "acute hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition",
            "criterions": [
                {
                    "exact_snippets": "poorly controlled diabetes mellitus",
                    "criterion": "diabetes mellitus control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of diabetes mellitus",
                    "criterion": "history of diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood glucose is within normal range",
                    "criterion": "blood glucose level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable dietary or therapeutic regimen",
                    "criterion": "dietary or therapeutic regimen stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has congestive heart failure > class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy",
            "criterions": [
                {
                    "exact_snippets": "congestive heart failure > class II New York Heart Association (NYHA)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "class II New York Heart Association (NYHA)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "new onset of angina pectoris",
                    "criterion": "new onset of angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac ventricular arrhythmias requiring antiarrhythmic therapy",
                    "criterion": "cardiac ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "antiarrhythmic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy",
            "criterions": [
                {
                    "exact_snippets": "The participant has experienced a hemorrhage or bleeding event",
                    "criterion": "hemorrhage or bleeding event",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": ">= National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks prior first dose of study therapy",
                    "criterion": "time since hemorrhage or bleeding event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}