{
    "info": {
        "nct_id": "NCT03403101",
        "official_title": "A Phase II, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of the Combination of S-1, Irinotecan and Oxaliplatin (SIRIOX) in Treating Patients With Advanced Inoperable or Metastatic Pancreatic Cancer",
        "inclusion_criteria": "1. Patients aged 18 - 75 years old at the time of signing the ICF.\n2. Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant are acceptable without Irinotecan, Oxaliplatin, or S1).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n4. Adequate hematologic function defined as: absolute neutrophil count (ANC) >= 2,000/μL; platelets count >= 100,000/μL; hemoglobin must be >= 10 g/dL (can be corrected by growth factor or transfusion).\n5. Adequate hepatic function defined as: serum bilirubin =< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed).\n6. Adequate renal function with: serum creatinine =< 1.3 mg/dL or calculated creatinine clearance >= 60 mL/minute according to the Cockcroft and Gault formula.\n7. At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n8. Life expectancy over 12 weeks.\n9. Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.\n10. Willing and able to comply with all aspects of the treatment protocol.\n11. Provide written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Patients who are unwilling or unable to comply with the study protocol;\n2. Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).\n3. Simultaneously using targeted therapies, such as Erlotinib, Nimotuzumab etc;\n4. Any severe or uncontrolled systemic disease (e.g., unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes mellitus, massive active bleeding);\n5. Large operations were performed within 14 days before entering the study, or there were surgical incisions that were not completely healed;\n6. Women who are pregnant or breastfeeding;\n7. Ascertained hypersensitivity to investigational product, Oxaliplatin, Irinotecan, and S1 or any of the excipients used in the study.\n8. History of other malignancies within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ;\n9. Obvious gastrointestinal injury history, the researchers estimate may significantly affect the absorption of S1 on the whole, including the ability to swallow drugs;\n10. Other combinations of anticancer therapies (including LHRH agonists, anticancer herbs, immunotherapy), except steroid hormones;\n11. Patients with UGT1A1 mutations or congenital disease lack of UGT1A1 expression (e.g. Crigler-Najjar syndrome and Gilbert syndrome);\n12. Patients with DPD enzyme deficiency.\n13. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients aged 18 - 75 years old at the time of signing the ICF.",
            "criterions": [
                {
                    "exact_snippets": "Patients aged 18 - 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant are acceptable without Irinotecan, Oxaliplatin, or S1).",
            "criterions": [
                {
                    "exact_snippets": "pathologically proved adenocarcinoma of pancreatic cancer",
                    "criterion": "adenocarcinoma of pancreatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically proved"
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with inoperable/metastatic disease",
                    "criterion": "disease operability/metastasis",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "inoperable/metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous systemic chemotherapy, neoadjuvant or adjuvant are acceptable without Irinotecan, Oxaliplatin, or S1",
                    "criterion": "previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": [
                                "systemic chemotherapy",
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "Irinotecan",
                                "Oxaliplatin",
                                "S1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Adequate hematologic function defined as: absolute neutrophil count (ANC) >= 2,000/μL; platelets count >= 100,000/μL; hemoglobin must be >= 10 g/dL (can be corrected by growth factor or transfusion).",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count (ANC) >= 2,000/μL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets count >= 100,000/μL",
                    "criterion": "platelets count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "μL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin must be >= 10 g/dL (can be corrected by growth factor or transfusion)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate hepatic function defined as: serum bilirubin =< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed).",
            "criterions": [
                {
                    "exact_snippets": "serum bilirubin =< 1.5-fold upper limit of normal (ULN)",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "fold ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "fold ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "fold ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed)",
                    "criterion": "alkaline phosphatase (ALP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "fold ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed)",
                    "criterion": "liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Adequate renal function with: serum creatinine =< 1.3 mg/dL or calculated creatinine clearance >= 60 mL/minute according to the Cockcroft and Gault formula.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function with: serum creatinine =< 1.3 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated creatinine clearance >= 60 mL/minute according to the Cockcroft and Gault formula",
                    "criterion": "calculated creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/minute"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST version 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Life expectancy over 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy over 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Women must be either of non-child bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": "non-child bearing"
                        }
                    ]
                },
                {
                    "exact_snippets": "women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant",
                    "criterion": "contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of hormonal contraception (estrogen/progesterone)",
                    "criterion": "hormonal contraception",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": [
                                "estrogen",
                                "progesterone"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "during treatment from time of Screening Visit and after cessation of therapy at least 3 months",
                    "criterion": "contraceptive duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during treatment from time of Screening Visit and after cessation of therapy at least 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Willing and able to comply with all aspects of the treatment protocol.",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to comply with all aspects of the treatment protocol.",
                    "criterion": "compliance with treatment protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Provide written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who are unwilling or unable to comply with the study protocol;",
            "criterions": [
                {
                    "exact_snippets": "unwilling or unable to comply with the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).",
            "criterions": [
                {
                    "exact_snippets": "Existing anticancer treatment-related toxicities of Grades >= 2 ... according to Common Terminology Criteria for Adverse Events (CTCAE v4.03)",
                    "criterion": "anticancer treatment-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Simultaneously using targeted therapies, such as Erlotinib, Nimotuzumab etc;",
            "criterions": [
                {
                    "exact_snippets": "Simultaneously using targeted therapies, such as Erlotinib, Nimotuzumab",
                    "criterion": "use of targeted therapies",
                    "requirements": [
                        {
                            "requirement_type": "simultaneous use",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "Erlotinib",
                                "Nimotuzumab"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Any severe or uncontrolled systemic disease (e.g., unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes mellitus, massive active bleeding);",
            "criterions": [
                {
                    "exact_snippets": "severe or uncontrolled systemic disease",
                    "criterion": "systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or decompensated breathing",
                    "criterion": "breathing condition",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or decompensated ... heart ... disease",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or decompensated ... liver ... disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or decompensated ... kidney disease",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "compensation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "massive active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "massive"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Large operations were performed within 14 days before entering the study, or there were surgical incisions that were not completely healed;",
            "criterions": [
                {
                    "exact_snippets": "Large operations were performed within 14 days before entering the study",
                    "criterion": "large operations",
                    "requirements": [
                        {
                            "requirement_type": "time since operation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical incisions that were not completely healed",
                    "criterion": "surgical incisions",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "not completely healed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Women who are pregnant or breastfeeding;",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Ascertained hypersensitivity to investigational product, Oxaliplatin, Irinotecan, and S1 or any of the excipients used in the study.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to investigational product",
                    "criterion": "hypersensitivity to investigational product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... Oxaliplatin",
                    "criterion": "hypersensitivity to Oxaliplatin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... Irinotecan",
                    "criterion": "hypersensitivity to Irinotecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... S1",
                    "criterion": "hypersensitivity to S1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients used in the study",
                    "criterion": "hypersensitivity to excipients used in the study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of other malignancies within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ;",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancies within 5 years",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ",
                    "criterion": "adequately treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Obvious gastrointestinal injury history, the researchers estimate may significantly affect the absorption of S1 on the whole, including the ability to swallow drugs;",
            "criterions": [
                {
                    "exact_snippets": "Obvious gastrointestinal injury history",
                    "criterion": "gastrointestinal injury history",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "obvious"
                        }
                    ]
                },
                {
                    "exact_snippets": "the ability to swallow drugs",
                    "criterion": "ability to swallow drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Other combinations of anticancer therapies (including LHRH agonists, anticancer herbs, immunotherapy), except steroid hormones;",
            "criterions": [
                {
                    "exact_snippets": "Other combinations of anticancer therapies (including LHRH agonists, anticancer herbs, immunotherapy), except steroid hormones",
                    "criterion": "anticancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "combinations",
                            "expected_value": [
                                "LHRH agonists",
                                "anticancer herbs",
                                "immunotherapy"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "steroid hormones"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with UGT1A1 mutations or congenital disease lack of UGT1A1 expression (e.g. Crigler-Najjar syndrome and Gilbert syndrome);",
            "criterions": [
                {
                    "exact_snippets": "UGT1A1 mutations",
                    "criterion": "UGT1A1 mutations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital disease lack of UGT1A1 expression",
                    "criterion": "UGT1A1 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Crigler-Najjar syndrome",
                    "criterion": "Crigler-Najjar syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert syndrome",
                    "criterion": "Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients with DPD enzyme deficiency.",
            "criterions": [
                {
                    "exact_snippets": "DPD enzyme deficiency",
                    "criterion": "DPD enzyme",
                    "requirements": [
                        {
                            "requirement_type": "deficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.",
            "criterions": [
                {
                    "exact_snippets": "difficulty of follow-up observation",
                    "criterion": "follow-up observation difficulty",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric disorder",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "any other serious diseases/medical history",
                    "criterion": "serious diseases/medical history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}