{
    "info": {
        "nct_id": "NCT06539091",
        "official_title": "A Single-Arm, Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (FAT-1)",
        "inclusion_criteria": "* ECOG PS: 0-1;\n\n  * Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;\n\n    * No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients concurrently enrolled in other clinical trials;\n\n  * Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;\n\n    * Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;\n\n      * Previous significant allergy to drugs or food or other substances;\n\n        * Subjects with untreated CNS metastases, previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery), may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose >10mg/day prednisone or other isotonic hormones) has been discontinued for >2 weeks without clinical evidence;\n\n          * Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function that, in the judgment of the investigator, may interfere with drug absorption;\n\n            * Have experienced clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months prior to randomization, such as peptic bleeding, bleeding gastric ulcer or suffering from vasculitis, etc. If the fecal occult blood is positive at the baseline period, it can be reviewed, and if it is still positive after review, combined with the clinical judgment, and if necessary, gastroscopy can be performed; ⑧The presence of currently uncontrolled malignant pleural fluid, ascites or pericardial effusion (defined as not effectively controlled by diuretics or puncture, as judged by the investigator);\n\n              * Presence of uncontrolled comorbidities including, but not limited to: active HBV or HCV infection, known HIV infection or history of AIDS, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic cardiac insufficiency, and active bleeding;\n\n                * Previous (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence > 3 years after completion of radical surgery; ⑪Women during pregnancy or lactation; ⑫Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment; ⑬In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* ECOG PS: 0-1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG PS: 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": "* Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;",
            "criterions": [
                {
                    "exact_snippets": "Initially treated patients",
                    "criterion": "treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "initially treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "high-grade plasma ovarian cancer (HGSOC)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "high-grade plasma ovarian cancer (HGSOC)"
                        }
                    ]
                },
                {
                    "exact_snippets": "fallopian tube cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "fallopian tube cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary peritoneal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "primary peritoneal cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "endometrioid carcinoma of the ovary",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "endometrioid carcinoma of the ovary"
                        }
                    ]
                },
                {
                    "exact_snippets": "FIGO stage III-IV",
                    "criterion": "FIGO stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.",
            "criterions": [
                {
                    "exact_snippets": "No prior maintenance therapy with PARP inhibitors",
                    "criterion": "prior maintenance therapy with PARP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin",
                    "criterion": "combination chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "components",
                            "expected_value": [
                                "bevacizumab",
                                "paclitaxel",
                                "carboplatin"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Good function of major organs",
                    "criterion": "function of major organs",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits",
                    "criterion": "voluntary enrollment and compliance",
                    "requirements": [
                        {
                            "requirement_type": "voluntary enrollment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "informed consent",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "compliance",
                            "expected_value": "good"
                        },
                        {
                            "requirement_type": "cooperation with follow-up visits",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1",
                    "criterion": "CA-125 ELIMination rate constant K (KELIM)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "N/A",
                            "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": "* Patients concurrently enrolled in other clinical trials;",
            "criterions": [
                {
                    "exact_snippets": "Patients concurrently enrolled in other clinical trials",
                    "criterion": "concurrent enrollment in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;",
            "criterions": [
                {
                    "exact_snippets": "Previous maintenance therapy with PARP inhibitors",
                    "criterion": "maintenance therapy with PARP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "combined with anti-angiogenic drugs",
                    "criterion": "anti-angiogenic drugs",
                    "requirements": [
                        {
                            "requirement_type": "combination with PARP inhibitors",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;",
            "criterions": [
                {
                    "exact_snippets": "Previous history of allergic reaction",
                    "criterion": "allergic reaction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous history of ... hypersensitivity reaction",
                    "criterion": "hypersensitivity reaction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous history of ... intolerance to antibody-based drugs",
                    "criterion": "intolerance to antibody-based drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous significant allergy to drugs or food or other substances;",
            "criterions": [
                {
                    "exact_snippets": "Previous significant allergy to drugs",
                    "criterion": "allergy to drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous significant allergy to ... food",
                    "criterion": "allergy to food",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous significant allergy to ... other substances",
                    "criterion": "allergy to other substances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with untreated CNS metastases, previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery), may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose >10mg/day prednisone or other isotonic hormones) has been discontinued for >2 weeks without clinical evidence;",
            "criterions": [
                {
                    "exact_snippets": "untreated CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery)",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": [
                                "systemic",
                                "radical brain",
                                "meningeal metastases",
                                "radiotherapy",
                                "surgery"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging confirms that stabilization has been maintained for at least 1 month",
                    "criterion": "CNS metastases stabilization",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic hormone therapy (dose >10mg/day prednisone or other isotonic hormones) has been discontinued for >2 weeks",
                    "criterion": "systemic hormone therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic hormone therapy (dose >10mg/day prednisone or other isotonic hormones)",
                    "criterion": "systemic hormone therapy dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function that, in the judgment of the investigator, may interfere with drug absorption;",
            "criterions": [
                {
                    "exact_snippets": "unable to swallow tablets normally",
                    "criterion": "ability to swallow tablets",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal gastrointestinal function",
                    "criterion": "gastrointestinal function",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may interfere with drug absorption",
                    "criterion": "drug absorption",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have experienced clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months prior to randomization, such as peptic bleeding, bleeding gastric ulcer or suffering from vasculitis, etc. If the fecal occult blood is positive at the baseline period, it can be reviewed, and if it is still positive after review, combined with the clinical judgment, and if necessary, gastroscopy can be performed; ⑧The presence of currently uncontrolled malignant pleural fluid, ascites or pericardial effusion (defined as not effectively controlled by diuretics or puncture, as judged by the investigator);",
            "criterions": [
                {
                    "exact_snippets": "Have experienced clinically significant bleeding symptoms",
                    "criterion": "clinically significant bleeding symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have a clear bleeding tendency within 3 months prior to randomization",
                    "criterion": "bleeding tendency",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "peptic bleeding",
                    "criterion": "peptic bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding gastric ulcer",
                    "criterion": "bleeding gastric ulcer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suffering from vasculitis",
                    "criterion": "vasculitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fecal occult blood is positive at the baseline period",
                    "criterion": "positive fecal occult blood",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of currently uncontrolled malignant pleural fluid",
                    "criterion": "uncontrolled malignant pleural fluid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of currently uncontrolled ... ascites",
                    "criterion": "uncontrolled ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of currently uncontrolled ... pericardial effusion",
                    "criterion": "uncontrolled pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of uncontrolled comorbidities including, but not limited to: active HBV or HCV infection, known HIV infection or history of AIDS, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic cardiac insufficiency, and active bleeding;",
            "criterions": [
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... active HBV or HCV infection",
                    "criterion": "active HBV or HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... known HIV infection or history of AIDS",
                    "criterion": "known HIV infection or history of AIDS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... active syphilis",
                    "criterion": "active syphilis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... active tuberculosis",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... symptomatic cardiac insufficiency",
                    "criterion": "symptomatic cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled comorbidities ... active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence > 3 years after completion of radical surgery; ⑪Women during pregnancy or lactation; ⑫Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment; ⑬In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples.",
            "criterions": [
                {
                    "exact_snippets": "Previous (within 5 years) or concurrent other untreated malignant tumors",
                    "criterion": "other untreated malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 5 years or concurrent"
                        }
                    ]
                },
                {
                    "exact_snippets": "cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence > 3 years after completion of radical surgery",
                    "criterion": "cured basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence > 3 years after completion of radical surgery",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence > 3 years after completion of radical surgery",
                    "criterion": "breast cancer without recurrence",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Women during pregnancy or lactation",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Women during pregnancy or lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment",
                    "criterion": "drug affecting study drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": "within 30 days or 5 half-lives (whichever is longer)"
                        }
                    ]
                },
                {
                    "exact_snippets": "In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples",
                    "criterion": "other factors causing study termination",
                    "requirements": [
                        {
                            "requirement_type": "investigator judgment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}