{
    "info": {
        "nct_id": "NCT00624182",
        "official_title": "Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer",
        "inclusion_criteria": "DISEASE CHARACTERISTICS\n\n1. Advanced bile duct cancer precluding curative surgical resection and recurrent bile duct cancer\n2. measurable disease by CT scan, ultrasonography, or other imaging modalities.\n\nPATIENTS CHARACTERISTICS\n\n1. ECOG performance status 0-2\n2. Life expectancy >3 months\n3. Laboratory values as follows 2,000/mm³< WBC < 15,000/mm³ Platelet count ≥ 75,000/mm³ Bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits\n4. HLA-A*2402 or HLA-A*0201\n5. Able and willing to give valid written informed consent\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)\n2. Breastfeeding\n3. Serious or uncontrolled infection\n4. Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4 weeks.\n5. Other malignancy within 5 years prior to entry into the study\n6. Concomitant treatment with steroids or immunosuppressing agent\n7. Disease to the central nervous system\n8. Decision of unsuitableness by principal investigator or physician-in-charge",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "DISEASE CHARACTERISTICS",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Advanced bile duct cancer precluding curative surgical resection and recurrent bile duct cancer",
            "criterions": [
                {
                    "exact_snippets": "Advanced bile duct cancer precluding curative surgical resection",
                    "criterion": "advanced bile duct cancer",
                    "requirements": [
                        {
                            "requirement_type": "surgical resection eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent bile duct cancer",
                    "criterion": "recurrent bile duct cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. measurable disease by CT scan, ultrasonography, or other imaging modalities.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease by CT scan, ultrasonography, or other imaging modalities.",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENTS CHARACTERISTICS",
            "criterions": [
                {
                    "exact_snippets": "PATIENTS CHARACTERISTICS",
                    "criterion": "patient characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "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": "2. Life expectancy >3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Laboratory values as follows 2,000/mm³< WBC < 15,000/mm³ Platelet count ≥ 75,000/mm³ Bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits",
            "criterions": [
                {
                    "exact_snippets": "2,000/mm³< WBC < 15,000/mm³",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 2000,
                                        "unit": "mm³"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 15000,
                                        "unit": "mm³"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥ 75,000/mm³",
                    "criterion": "Platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "mm³"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 x the institutional normal upper limits",
                    "criterion": "Bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x the institutional normal upper limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits",
                    "criterion": "AST, ALT, ALP",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x the institutional normal upper limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine ≤ 1.5 x the institutional normal upper limits",
                    "criterion": "Creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x the institutional normal upper limits"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. HLA-A*2402 or HLA-A*0201",
            "criterions": [
                {
                    "exact_snippets": "HLA-A*2402",
                    "criterion": "HLA type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A*2402"
                        }
                    ]
                },
                {
                    "exact_snippets": "HLA-A*0201",
                    "criterion": "HLA type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "HLA-A*0201"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Able and willing to give valid written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to give valid written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing potential: Refusal or inability to use effective means of contraception",
                    "criterion": "use of effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not breastfeeding"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Serious or uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": "Serious or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy (except gemcitabine)",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "immunotherapy within 4 weeks",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Other malignancy within 5 years prior to entry into the study",
            "criterions": [
                {
                    "exact_snippets": "Other malignancy within 5 years prior to entry into the study",
                    "criterion": "other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Concomitant treatment with steroids or immunosuppressing agent",
            "criterions": [
                {
                    "exact_snippets": "Concomitant treatment with steroids",
                    "criterion": "concomitant steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant treatment with ... immunosuppressing agent",
                    "criterion": "concomitant immunosuppressing agent treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Disease to the central nervous system",
            "criterions": [
                {
                    "exact_snippets": "Disease to the central nervous system",
                    "criterion": "central nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Decision of unsuitableness by principal investigator or physician-in-charge",
            "criterions": [
                {
                    "exact_snippets": "Decision of unsuitableness by principal investigator or physician-in-charge",
                    "criterion": "suitability",
                    "requirements": [
                        {
                            "requirement_type": "decision",
                            "expected_value": "unsuitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}