{
    "info": {
        "nct_id": "NCT05896020",
        "official_title": "Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies",
        "inclusion_criteria": "1. The subjects voluntarily joined the study and signed the ICF.\n2. Measurable disease, as defined by RECIST v1.1.\n3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 12 weeks.\n5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Symptomatic, untreated or active central nervous system metastases.\n2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..\n3. Have uncontrolled or severe cardiovascular disease.\n4. With any active autoimmune disease or history of autoimmune disease.\n5. Patients with active hepatitis B or hepatitis C.\n6. Severe infections within 28 days prior to initiation of study treatment.\n7. Active tuberculosis within one year prior to initiation of study treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. The subjects voluntarily joined the study and signed the ICF.",
            "criterions": [
                {
                    "exact_snippets": "The subjects voluntarily joined the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the ICF",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Measurable disease, as defined by RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease, as defined by RECIST v1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Life expectancy ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 12 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.",
            "criterions": [
                {
                    "exact_snippets": "advanced cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent ovarian cancer",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "endometrial cancer",
                    "criterion": "endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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. Symptomatic, untreated or active central nervous system metastases.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic, untreated or active central nervous system metastases.",
                    "criterion": "central nervous system metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..",
            "criterions": [
                {
                    "exact_snippets": "Previously received antibo-conjugated drugs",
                    "criterion": "previous treatment with antibo-conjugated drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "topoisomerase I inhibition in the composition",
                    "criterion": "topoisomerase I inhibition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Preparations, such as Enhertu (DS-8201a), U3-1402, etc.",
                    "criterion": "specific drugs",
                    "requirements": [
                        {
                            "requirement_type": "list",
                            "expected_value": [
                                "Enhertu (DS-8201a)",
                                "U3-1402"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have uncontrolled or severe cardiovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled or severe cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. With any active autoimmune disease or history of autoimmune disease.",
            "criterions": [
                {
                    "exact_snippets": "active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with active hepatitis B or hepatitis C.",
            "criterions": [
                {
                    "exact_snippets": "Patients with active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with active ... hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Severe infections within 28 days prior to initiation of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Severe infections within 28 days prior to initiation of study treatment.",
                    "criterion": "severe infections",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days prior to initiation of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Active tuberculosis within one year prior to initiation of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Active tuberculosis within one year prior to initiation of study treatment.",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}