{
    "info": {
        "nct_id": "NCT05819060",
        "official_title": "The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer",
        "inclusion_criteria": "1. Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;\n2. Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;\n3. Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;\n4. Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;\n5. The patient achieved a complete or partial response after the last platinum-based chemotherapy;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n7. The patient has a life expectancy of at least 3 months and sufficient organ function;\n8. The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;\n9. The patient voluntarily agrees to participate in this study and signs an informed consent form.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;\n2. Patients who have undergone major surgery within 28 days prior to enrollment;\n3. Patients with central nervous system metastases or a history of seizures within the past 12 months;\n4. Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;\n5. NYHA functional class ≥ III;\n6. Patients with severe, uncontrolled systemic diseases;\n7. Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;\n8. Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;\n9. Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;\n10. Patients judged by the investigator to be unsuitable for participation in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;",
            "criterions": [
                {
                    "exact_snippets": "platinum-sensitive recurrent ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "platinum-sensitive"
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by pathology or histology",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "pathology",
                                "histology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "previously received platinum-based chemotherapy",
                    "criterion": "platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence interval of > 6 months before the last platinum-based chemotherapy",
                    "criterion": "recurrence interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received bevacizumab",
                    "criterion": "previous bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "did not experience progression within 3 months during the use of bevacizumab",
                    "criterion": "disease progression during bevacizumab use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received PARP inhibitors",
                    "criterion": "previous PARP inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "did not experience progression within 12 months during the use of PARP inhibitors",
                    "criterion": "progression during PARP inhibitor use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The patient achieved a complete or partial response after the last platinum-based chemotherapy;",
            "criterions": [
                {
                    "exact_snippets": "The patient achieved a complete or partial response after the last platinum-based chemotherapy",
                    "criterion": "response to platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response type",
                            "expected_value": [
                                "complete",
                                "partial"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The patient has a life expectancy of at least 3 months and sufficient organ function;",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;",
            "criterions": [
                {
                    "exact_snippets": "sufficient bone marrow reserves",
                    "criterion": "bone marrow reserves",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance rate of 45 mL/min",
                    "criterion": "creatinine clearance rate",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The patient voluntarily agrees to participate in this study and signs an informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "The patient voluntarily agrees to participate in this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signs an informed consent form",
                    "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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 known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;",
            "criterions": [
                {
                    "exact_snippets": "Patients who are known to be allergic or intolerant to chemotherapy drugs",
                    "criterion": "allergy or intolerance to chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are known to be allergic or intolerant to ... excipients",
                    "criterion": "allergy or intolerance to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who ... cannot swallow medication",
                    "criterion": "ability to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who have undergone major surgery within 28 days prior to enrollment;",
            "criterions": [
                {
                    "exact_snippets": "undergone major surgery within 28 days prior to enrollment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with central nervous system metastases or a history of seizures within the past 12 months;",
            "criterions": [
                {
                    "exact_snippets": "central nervous system metastases",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of seizures within the past 12 months",
                    "criterion": "history of seizures",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 12 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure ≥180mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 180,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure ≥90mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. NYHA functional class ≥ III;",
            "criterions": [
                {
                    "exact_snippets": "NYHA functional class ≥ III",
                    "criterion": "NYHA functional class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with severe, uncontrolled systemic diseases;",
            "criterions": [
                {
                    "exact_snippets": "severe, uncontrolled systemic diseases",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received any other investigational drug treatment",
                    "criterion": "investigational drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participated in any other clinical trials within 30 days prior to enrollment",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating patients",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who cannot guarantee effective contraception",
                    "criterion": "contraception guarantee",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;",
            "criterions": [
                {
                    "exact_snippets": "poorly controlled neurological or psychiatric disorders or mental illness",
                    "criterion": "neurological or psychiatric disorders or mental illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "poor compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to cooperate",
                    "criterion": "ability to cooperate",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to ... describe treatment response",
                    "criterion": "ability to describe treatment response",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients judged by the investigator to be unsuitable for participation in this study.",
            "criterions": [
                {
                    "exact_snippets": "Patients judged by the investigator to be unsuitable for participation",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}