{
    "info": {
        "nct_id": "NCT06141265",
        "official_title": "Chemotherapy Combined With Bevacizumab Followed by Niraparib Monotherapy in Newly Diagnostic Advanced Ovarian Cancer With HRD Positive : A Perspective, Multicenter, Single-arm Phase II Trial",
        "inclusion_criteria": "1. The written informed consent form shall be signed before proceeding with any study-related procedure.\n2. Participants shall be a female, aged 18 years or older.\n3. Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma。\n4. FIGO staging is Stage III or IV.\n5. Patients who have undergone primary tumor reductive surgery or intermittent tumor reductive surgery (patients who have used neoadjuvant therapy), regardless of postoperative residual lesion status\n6. Participants must have received, prior to enrollment, a minimum of 2 cycles of bevacizumab in combination with platinum-based chemotherapy.\n7. Participants must have completed front-line, platinum-based chemotherapy with CR, PR, or NED assessed by RECIST v1.1.\n8. Participant must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir).\n9. Participants must have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy.\n10. Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.\n11. Participant must have an Eastern Cooperative Oncology Group (ECOG) score ≤2.\n12. Organ function is in good condition, including: Hemoglobin ≥100 g/L; White blood cell count ≥3×10^9/L; Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin is not more than 1.5 times the normal upper limit; ALK, AST and ALT are not more than 2.5 times their normal upper limit, and with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit; Serum creatinine is not more than 1.5 times the normal upper limit.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Histopathological types other than high-grade ovarian/tubal/peritoneal cancer or metastatic ovarian cancer.\n2. Receipt of other targeted drugs as maintenance therapy, excluding PARP inhibitors.\n3. Concurrent severe respiratory or hematologic disorders, poorly controlled diabetes, uncontrolled hypertension of Grade 2 or higher, NYHA Class III or higher congestive heart failure, unstable angina, recent myocardial infarction within the past 6 months, or other circulatory system diseases.\n4. Any other significant complications or functional impairments in organ systems, as determined by the investigator, that may affect the safety of the participant or interfere with the evaluation of the investigational drug.\n5. Expected survival less than 3 months.\n6. Other than ovarian cancer, the participant has been diagnosed a second primary tumor within the past 2 years and currently undergoing treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. The written informed consent form shall be signed before proceeding with any study-related procedure.",
            "criterions": [
                {
                    "exact_snippets": "The written informed consent form shall be signed",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Participants shall be a female, aged 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Participants shall be a female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed primary high-grade epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma。",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed primary high-grade epithelial ovarian cancer",
                    "criterion": "primary high-grade epithelial ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... fallopian tube carcinoma",
                    "criterion": "fallopian tube carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... primary peritoneal carcinoma",
                    "criterion": "primary peritoneal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. FIGO staging is Stage III or IV.",
            "criterions": [
                {
                    "exact_snippets": "FIGO staging is Stage III or IV.",
                    "criterion": "FIGO staging",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage III",
                                "Stage IV"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients who have undergone primary tumor reductive surgery or intermittent tumor reductive surgery (patients who have used neoadjuvant therapy), regardless of postoperative residual lesion status",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone primary tumor reductive surgery",
                    "criterion": "primary tumor reductive surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intermittent tumor reductive surgery",
                    "criterion": "intermittent tumor reductive surgery",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who have used neoadjuvant therapy",
                    "criterion": "neoadjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Participants must have received, prior to enrollment, a minimum of 2 cycles of bevacizumab in combination with platinum-based chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Participants must have received, prior to enrollment, a minimum of 2 cycles of bevacizumab",
                    "criterion": "bevacizumab cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must have received, prior to enrollment, ... platinum-based chemotherapy",
                    "criterion": "platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Participants must have completed front-line, platinum-based chemotherapy with CR, PR, or NED assessed by RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "Participants must have completed front-line, platinum-based chemotherapy",
                    "criterion": "completion of front-line, platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CR, PR, or NED assessed by RECIST v1.1",
                    "criterion": "response to chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "CR",
                                "PR",
                                "NED"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Participant must have either CA-125 in the normal range or CA-125 decrease by more than 90% during front-line therapy that is stable for at least 7 days (ie, no increase > 15% from nadir).",
            "criterions": [
                {
                    "exact_snippets": "CA-125 in the normal range",
                    "criterion": "CA-125 level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "CA-125 decrease by more than 90% during front-line therapy",
                    "criterion": "CA-125 level",
                    "requirements": [
                        {
                            "requirement_type": "decrease",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no increase > 15% from nadir",
                    "criterion": "CA-125 level",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": "<=",
                                "value": 15,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Participants must have first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "first study treatment dose within 12 weeks of the first day of the last cycle of chemotherapy",
                    "criterion": "timing of first study treatment dose",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 12 weeks of the first day of the last cycle of chemotherapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Genetic testing of tumor tissue indicates HRD positive or germline/somatic BRCA mutation prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Genetic testing of tumor tissue indicates HRD positive",
                    "criterion": "HRD status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Genetic testing of tumor tissue indicates ... germline/somatic BRCA mutation",
                    "criterion": "BRCA mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Participant must have an Eastern Cooperative Oncology Group (ECOG) score ≤2.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score ≤2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Organ function is in good condition, including: Hemoglobin ≥100 g/L; White blood cell count ≥3×10^9/L; Neutrophil count ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin is not more than 1.5 times the normal upper limit; ALK, AST and ALT are not more than 2.5 times their normal upper limit, and with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit; Serum creatinine is not more than 1.5 times the normal upper limit.",
            "criterions": [
                {
                    "exact_snippets": "Organ function is in good condition",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥100 g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "White blood cell count ≥3×10^9/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophil count ≥1.5×10^9/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥100×10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin is not more than 1.5 times the normal upper limit",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the normal upper limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK, AST and ALT are not more than 2.5 times their normal upper limit",
                    "criterion": "ALK, AST, and ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times their normal upper limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with existence of hepatic metastasis, these values must not be more than 5 times their normal upper limit",
                    "criterion": "ALK, AST, and ALT levels with hepatic metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times their normal upper limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine is not more than 1.5 times the normal upper limit",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the normal upper limit"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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. Histopathological types other than high-grade ovarian/tubal/peritoneal cancer or metastatic ovarian cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histopathological types other than high-grade ovarian/tubal/peritoneal cancer",
                    "criterion": "histopathological type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "high-grade ovarian cancer",
                                "high-grade tubal cancer",
                                "high-grade peritoneal cancer"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histopathological types other than ... metastatic ovarian cancer",
                    "criterion": "histopathological type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "metastatic ovarian cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Receipt of other targeted drugs as maintenance therapy, excluding PARP inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Receipt of other targeted drugs as maintenance therapy",
                    "criterion": "receipt of other targeted drugs",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding PARP inhibitors",
                    "criterion": "receipt of PARP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Concurrent severe respiratory or hematologic disorders, poorly controlled diabetes, uncontrolled hypertension of Grade 2 or higher, NYHA Class III or higher congestive heart failure, unstable angina, recent myocardial infarction within the past 6 months, or other circulatory system diseases.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent severe respiratory ... disorders",
                    "criterion": "respiratory disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent severe ... hematologic disorders",
                    "criterion": "hematologic disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled hypertension of Grade 2 or higher",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "NYHA Class III or higher congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA Class",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "recent myocardial infarction within the past 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other circulatory system diseases",
                    "criterion": "circulatory system diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Any other significant complications or functional impairments in organ systems, as determined by the investigator, that may affect the safety of the participant or interfere with the evaluation of the investigational drug.",
            "criterions": [
                {
                    "exact_snippets": "significant complications or functional impairments in organ systems",
                    "criterion": "complications or functional impairments in organ systems",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by the investigator",
                    "criterion": "investigator determination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may affect the safety of the participant",
                    "criterion": "effect on participant safety",
                    "requirements": [
                        {
                            "requirement_type": "potential impact",
                            "expected_value": "may affect"
                        }
                    ]
                },
                {
                    "exact_snippets": "interfere with the evaluation of the investigational drug",
                    "criterion": "interference with drug evaluation",
                    "requirements": [
                        {
                            "requirement_type": "potential impact",
                            "expected_value": "interfere"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Expected survival less than 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival less than 3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Other than ovarian cancer, the participant has been diagnosed a second primary tumor within the past 2 years and currently undergoing treatment.",
            "criterions": [
                {
                    "exact_snippets": "Other than ovarian cancer, the participant has been diagnosed a second primary tumor",
                    "criterion": "second primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 2 years",
                    "criterion": "second primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "currently undergoing treatment",
                    "criterion": "second primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "undergoing treatment"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}