{
    "info": {
        "nct_id": "NCT03863860",
        "official_title": "A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer",
        "inclusion_criteria": "1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)\n2. Completion of ≥2 previous platinum-containing regimens\n3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator\n4. Ability to be randomized ≤8 weeks after last dose of platinum\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor\n2. Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).\n3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)",
            "criterions": [
                {
                    "exact_snippets": "Histologically diagnosed high-grade serous or endometrioid ovarian cancer",
                    "criterion": "ovarian cancer type",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": [
                                "high-grade serous",
                                "endometrioid"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "primary peritoneal and fallopian tube cancer",
                    "criterion": "cancer location",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "primary peritoneal",
                                "fallopian tube"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Completion of ≥2 previous platinum-containing regimens",
            "criterions": [
                {
                    "exact_snippets": "Completion of ≥2 previous platinum-containing regimens",
                    "criterion": "platinum-containing regimens",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator",
            "criterions": [
                {
                    "exact_snippets": "Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen",
                    "criterion": "response to last platinum-based chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "complete response",
                                "partial response"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by investigator",
                    "criterion": "investigator determination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Ability to be randomized ≤8 weeks after last dose of platinum",
            "criterions": [
                {
                    "exact_snippets": "Ability to be randomized ≤8 weeks after last dose of platinum",
                    "criterion": "randomization timing",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose of platinum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor",
                    "criterion": "treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received other study drug treatment within 4 weeks prior to the first administration",
                    "criterion": "prior study drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs)",
                    "criterion": "elimination half-lives of study drug",
                    "requirements": [
                        {
                            "requirement_type": "number of half-lives",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "elimination half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.",
            "criterions": [
                {
                    "exact_snippets": "clinical symptoms of cancer ascites",
                    "criterion": "cancer ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "need to drainage",
                    "criterion": "need for drainage",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone ascites drainage within 2 months prior to the first administration",
                    "criterion": "ascites drainage",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}