{
    "info": {
        "nct_id": "NCT01781520",
        "official_title": "Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.",
        "inclusion_criteria": "* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.\n* Capable of oral intake\n* Between 18 and 80 years old\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Karnofsky Performance Status (KPS) ≥ 70%\n* Normal functions of heart, lung and bone marrow\n* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3\n* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN\n* Adequate renal function(normal serum creatinine level)\n* A life expectancy≥ 2 months\n* Informed consent signed\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study\n* Any radiotherapy or surgery within the previous 3 weeks\n* Symptomatic brain metastasis not controlled by corticosteroids\n* Bone marrow metastasis\n* Active infection\n* Serious complications\n* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.\n* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "adenocarcinoma confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced, unresectable or metastatic adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "unresectable",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pancreas"
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative radiotherapy or surgery",
                    "criterion": "treatment amenability",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": [
                                "not amenable to curative radiotherapy",
                                "not amenable to surgery"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Capable of oral intake",
            "criterions": [
                {
                    "exact_snippets": "Capable of oral intake",
                    "criterion": "oral intake capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Between 18 and 80 years old",
            "criterions": [
                {
                    "exact_snippets": "Between 18 and 80 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky Performance Status (KPS) ≥ 70%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status (KPS) ≥ 70%",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal functions of heart, lung and bone marrow",
            "criterions": [
                {
                    "exact_snippets": "Normal functions of heart",
                    "criterion": "heart function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal functions of ... lung",
                    "criterion": "lung function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Normal functions of ... bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute granulocyte count ≥ 1,500/mm3",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Adequate hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "adequate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin level≤ 3.0 times the upper limit of normal (ULN)",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN",
                    "criterion": "transaminases AST (SGOT) and ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function(normal serum creatinine level)",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function(normal serum creatinine level)",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "normal serum creatinine level"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A life expectancy≥ 2 months",
            "criterions": [
                {
                    "exact_snippets": "life expectancy≥ 2 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent signed",
            "criterions": [
                {
                    "exact_snippets": "Informed consent signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study",
            "criterions": [
                {
                    "exact_snippets": "Current enrollment in another clinical study with an investigational agent",
                    "criterion": "enrollment in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any radiotherapy or surgery within the previous 3 weeks",
            "criterions": [
                {
                    "exact_snippets": "Any radiotherapy ... within the previous 3 weeks",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any ... surgery within the previous 3 weeks",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic brain metastasis not controlled by corticosteroids",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not controlled by corticosteroids",
                    "criterion": "corticosteroid control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone marrow metastasis",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow metastasis",
                    "criterion": "bone marrow metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious complications",
            "criterions": [
                {
                    "exact_snippets": "Serious complications",
                    "criterion": "serious complications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.",
            "criterions": [
                {
                    "exact_snippets": "Receiving a concomitant treatment with drugs interacting with S-1",
                    "criterion": "concomitant treatment with drugs interacting with S-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "phenytoin",
                    "criterion": "phenytoin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "potassium warfarin",
                    "criterion": "potassium warfarin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "flucytosine",
                    "criterion": "flucytosine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cimetidine",
                    "criterion": "cimetidine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "folinic acid",
                    "criterion": "folinic acid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women with known or suspected pregnancy",
                    "criterion": "known or suspected pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "men who want let to pregnancy",
                    "criterion": "men's intention for pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "not to cause pregnancy"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}