{
    "info": {
        "nct_id": "NCT00122876",
        "official_title": "A Phase 1/2 Open-Label Study to Evaluate Safety and Preliminary Evidence of Effectiveness of Tumor Ablation With Talaporfin Sodium (LS11) and Interstitial Light Emitting Diodes (LEDs) in the Treatment of Subjects With Inoperable Hepatocellular Carcinoma (HCC)",
        "inclusion_criteria": "* A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: (i) Two different imaging techniques that suggests HCC; (ii) Combination of one imaging technique that suggests HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence of HCC;\n* Subjects with at least 1 but no more than 3 lesions in the liver may be considered for enrollment in the study;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;\n* Life expectancy of at least 16 weeks;\n* Prior treatment failure with locally ablative techniques is allowed. Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible, but at least 4 weeks must have elapsed since the completion of any prior therapy and the subject must have recovered from acute side effects;\n* Understanding and ability to sign written informed consent;\n* 18 years of age or more;\n* Adequate hematologic, liver and renal functions as evidenced by the following: *WBC > 2,400/mm; *Platelet Count > 75,000/µl; *Hemoglobin > 9.4 gm/dL; *PT and PTT < 1.5 Control; *AST, ALT < 5 x ULN; *Bilirubin < 1.5 X ULN; *Alk Phos < 3X ULN; *Creatinine < 2.5 mg/dL (SI: 221 mmol/L)\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects who are candidates for surgery with curative intent;\n* Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal disease involvement;\n* Known sensitivity to porphyrin type drugs;\n* Known history of porphyria;\n* Known presence of extrahepatic metastases;\n* Anticipated need for systemic chemotherapy during the first 8 weeks of the study;\n* Child-Pugh C cirrhosis;\n* Diffuse HCC;\n* Concurrent participation in another clinical trial involving experimental treatment;\n* Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: (i) Two different imaging techniques that suggests HCC; (ii) Combination of one imaging technique that suggests HCC and serum alpha-fetoprotein (AFP) level >400 ng/mL; (iii) Histological evidence of HCC;",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of primary Hepatocellular Carcinoma (HCC)",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "primary Hepatocellular Carcinoma (HCC)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Two different imaging techniques that suggests HCC",
                    "criterion": "imaging techniques",
                    "requirements": [
                        {
                            "requirement_type": "number",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "techniques"
                            }
                        },
                        {
                            "requirement_type": "suggestion",
                            "expected_value": "HCC"
                        }
                    ]
                },
                {
                    "exact_snippets": "one imaging technique that suggests HCC",
                    "criterion": "imaging technique",
                    "requirements": [
                        {
                            "requirement_type": "number",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "technique"
                            }
                        },
                        {
                            "requirement_type": "suggestion",
                            "expected_value": "HCC"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum alpha-fetoprotein (AFP) level >400 ng/mL",
                    "criterion": "serum alpha-fetoprotein (AFP) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 400,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Histological evidence of HCC",
                    "criterion": "histological evidence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "HCC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with at least 1 but no more than 3 lesions in the liver may be considered for enrollment in the study;",
            "criterions": [
                {
                    "exact_snippets": "at least 1 but no more than 3 lesions in the liver",
                    "criterion": "liver lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 16 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 16 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment failure with locally ablative techniques is allowed. Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible, but at least 4 weeks must have elapsed since the completion of any prior therapy and the subject must have recovered from acute side effects;",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment failure with locally ablative techniques is allowed.",
                    "criterion": "prior treatment failure with locally ablative techniques",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who were not candidates for surgery, systemic chemotherapy, chemoembolization (TACE), intratumoral ethanol injection (PEI), radiofrequency ablation (RFA), cryoablation or other locally ablative technology may be eligible",
                    "criterion": "candidacy for specific treatments",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": [
                                "surgery",
                                "systemic chemotherapy",
                                "chemoembolization (TACE)",
                                "intratumoral ethanol injection (PEI)",
                                "radiofrequency ablation (RFA)",
                                "cryoablation",
                                "other locally ablative technology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 4 weeks must have elapsed since the completion of any prior therapy",
                    "criterion": "time since completion of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the subject must have recovered from acute side effects",
                    "criterion": "recovery from acute side effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Understanding and ability to sign written informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Understanding and ability to sign written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability to sign",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years of age or more;",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or more",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematologic, liver and renal functions as evidenced by the following: *WBC > 2,400/mm; *Platelet Count > 75,000/µl; *Hemoglobin > 9.4 gm/dL; *PT and PTT < 1.5 Control; *AST, ALT < 5 x ULN; *Bilirubin < 1.5 X ULN; *Alk Phos < 3X ULN; *Creatinine < 2.5 mg/dL (SI: 221 mmol/L)",
            "criterions": [
                {
                    "exact_snippets": "WBC > 2,400/mm",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2400,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet Count > 75,000/µl",
                    "criterion": "Platelet Count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 75000,
                                "unit": "µl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin > 9.4 gm/dL",
                    "criterion": "Hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.4,
                                "unit": "gm/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT and PTT < 1.5 Control",
                    "criterion": "PT and PTT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "Control"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST, ALT < 5 x ULN",
                    "criterion": "AST, ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin < 1.5 X ULN",
                    "criterion": "Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alk Phos < 3X ULN",
                    "criterion": "Alk Phos",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine < 2.5 mg/dL (SI: 221 mmol/L)",
                    "criterion": "Creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subjects who are candidates for surgery with curative intent;",
            "criterions": [
                {
                    "exact_snippets": "candidates for surgery with curative intent",
                    "criterion": "surgery candidacy",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with lesions larger than 8 cm in diameter and more than 40% of parenchymal disease involvement;",
            "criterions": [
                {
                    "exact_snippets": "lesions larger than 8 cm in diameter",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 40% of parenchymal disease involvement",
                    "criterion": "parenchymal disease involvement",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known sensitivity to porphyrin type drugs;",
            "criterions": [
                {
                    "exact_snippets": "Known sensitivity to porphyrin type drugs",
                    "criterion": "sensitivity to porphyrin type drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known history of porphyria;",
            "criterions": [
                {
                    "exact_snippets": "Known history of porphyria",
                    "criterion": "porphyria",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known presence of extrahepatic metastases;",
            "criterions": [
                {
                    "exact_snippets": "Known presence of extrahepatic metastases",
                    "criterion": "extrahepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anticipated need for systemic chemotherapy during the first 8 weeks of the study;",
            "criterions": [
                {
                    "exact_snippets": "Anticipated need for systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "anticipated need",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the first 8 weeks of the study",
                    "criterion": "timeframe for systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Child-Pugh C cirrhosis;",
            "criterions": [
                {
                    "exact_snippets": "Child-Pugh C cirrhosis",
                    "criterion": "Child-Pugh score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "C"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diffuse HCC;",
            "criterions": [
                {
                    "exact_snippets": "Diffuse HCC",
                    "criterion": "HCC (Hepatocellular Carcinoma)",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "Diffuse"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent participation in another clinical trial involving experimental treatment;",
            "criterions": [
                {
                    "exact_snippets": "Concurrent participation in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "involving experimental treatment",
                    "criterion": "experimental treatment",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.",
            "criterions": [
                {
                    "exact_snippets": "Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial.",
                    "criterion": "concurrent disease or condition",
                    "requirements": [
                        {
                            "requirement_type": "impairment of trial completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.",
                    "criterion": "conditions affecting compliance or data interpretation",
                    "requirements": [
                        {
                            "requirement_type": "compromise compliance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "obscure data interpretation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}