{
    "info": {
        "nct_id": "NCT03924882",
        "official_title": "A Phase II Study of Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer",
        "inclusion_criteria": "1. Female, age ≥18 years and ≤70 years, signed informed consent.\n2. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.\n3. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)\n4. At least treated with one line of platinum-based chemotherapy\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125\n7. Patients must have a life expectancy of at least 3 months.\n8. Patients must have adequate organ function.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension\n2. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.\n3. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1\n4. Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1\n5. Symptomatic central nervous system (CNS) metastasis",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Female, age ≥18 years and ≤70 years, signed informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "age ≥18 years and ≤70 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "age ≥18 years and ≤70 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary",
                        "criterion": "epithelial carcinoma of the ovary",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "pathologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary",
                        "criterion": "epithelial carcinoma of the ovary",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "pathologically"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)",
                "criterions": [
                    {
                        "exact_snippets": "Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy)",
                        "criterion": "platinum resistant ovarian cancer",
                        "requirement": {
                            "requirement_type": "relapse timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)",
                        "criterion": "platinum refractory ovarian cancer",
                        "requirement": {
                            "requirement_type": "progression timing",
                            "expected_value": "while on platinum-based chemotherapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy)",
                        "criterion": "platinum resistant ovarian cancer",
                        "requirement": {
                            "requirement_type": "relapse timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)",
                        "criterion": "platinum refractory ovarian cancer",
                        "requirement": {
                            "requirement_type": "progression timing",
                            "expected_value": "while on platinum-based chemotherapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. At least treated with one line of platinum-based chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "At least treated with one line of platinum-based chemotherapy",
                        "criterion": "platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least treated with one line of platinum-based chemotherapy",
                        "criterion": "platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. 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",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Measurable disease according to ... CA125",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "CA125"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Measurable disease according to ... CA125",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "CA125"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Patients must have a life expectancy of at least 3 months.",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy of at least 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy of at least 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Patients must have adequate organ function.",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate organ function",
                        "criterion": "organ function",
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                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
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                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
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                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
                            "expected_value": {
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                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 70 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 70 Years",
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                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension",
                "criterions": [
                    {
                        "exact_snippets": "prior exposure to anlotinib",
                        "criterion": "prior exposure to anlotinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "known allegies to any of the excipients",
                        "criterion": "allergies to excipients",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Inadequately controlled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "inadequately controlled"
                        }
                    }
                ]
            },
            "logical_structure": {
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                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "known allegies to any of the excipients",
                        "criterion": "allergies to excipients",
                        "requirement": {
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                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Inadequately controlled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "inadequately controlled"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.",
                "criterions": [
                    {
                        "exact_snippets": "History of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association (NYHA) Grade III-IV",
                        "criterion": "NYHA classification",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within 6 months prior to Day 1",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within 6 months prior to Day 1",
                                "criterion": "time since event",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "New York Heart Association (NYHA) Grade III-IV",
                                "criterion": "NYHA classification",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": {
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                                            {
                                                "operator": ">=",
                                                "value": 3,
                                                "unit": "N/A"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "within 6 months prior to Day 1",
                                "criterion": "time since event",
                                "requirement": {
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                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1",
                "criterions": [
                    {
                        "exact_snippets": "History of abdominal fistula",
                        "criterion": "abdominal fistula",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal perforation within 28 days prior to Day 1",
                        "criterion": "gastrointestinal perforation",
                        "requirement": {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
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                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "gastrointestinal perforation within 28 days prior to Day 1",
                        "criterion": "gastrointestinal perforation",
                        "requirement": {
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                            "expected_value": {
                                "comparisons": [
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                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
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                        }
                    }
                ]
            }
        },
        {
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                "line": "4. Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1",
                "criterions": [
                    {
                        "exact_snippets": "Major surgical procedure within 28 days prior to Day 1",
                        "criterion": "major surgical procedure",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
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                        }
                    },
                    {
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                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "bowel obstruction within 28 days prior to Day 1",
                        "criterion": "bowel obstruction",
                        "requirement": {
                            "requirement_type": "time since condition",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "and_criteria": [
                            {
                                "exact_snippets": "Major surgical procedure within 28 days prior to Day 1",
                                "criterion": "major surgical procedure",
                                "requirement": {
                                    "requirement_type": "time since procedure",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                }
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                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Serious, non-healing wound",
                                "criterion": "serious, non-healing wound",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active ulcer",
                                "criterion": "active ulcer",
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                                }
                            }
                        ]
                    },
                    {
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                            {
                                "exact_snippets": "bowel obstruction within 28 days prior to Day 1",
                                "criterion": "bowel obstruction",
                                "requirement": {
                                    "requirement_type": "time since condition",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Symptomatic central nervous system (CNS) metastasis",
                "criterions": [
                    {
                        "exact_snippets": "Symptomatic central nervous system (CNS) metastasis",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Symptomatic central nervous system (CNS) metastasis",
                        "criterion": "central nervous system (CNS) metastasis",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}