{
    "info": {
        "nct_id": "NCT05016973",
        "official_title": "A Clinical Study of RC48-ADC Combined With Triplizumab as Neoadjuvant Therapy Before Radical Resection of Myometrial Invasive Bladder Cancer",
        "inclusion_criteria": "1. Patients with myometrial invasive bladder cancer are prepared for radical cystectomy;\n2. HER2 overexpression confirmed by pathological biopsy: IHC2+ or IHC3+; subjects can provide tumor samples detected by HER2;\n3. Age ≥ 18 years old and ≤ 80 years old;\n4. Tumor clinical stage is (c) T2-3bN0M0;\n5. ECOG score ≤ 1;\n6. Subjects have not received systemic chemotherapy, ADC drugs or immunotherapy.\n7. The important laboratory examination indexes meet the following requirements:\n\n   1. Hemoglobin ≥ 90g/L.\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L.\n   3. Platelet ≥ 100 × 109 / L.\n   4. 3.5mmol/L ≤ serum potassium ≤ 5.5mmol/L.\n   5. Liver function index: ALT, AST ≤ 1.5 times the upper limit of normal value (ULN), TBIL ≤ 1.5ULN.\n   6. eGFR ≥ 50 mL/min\n   7. The left ventricular ejection fraction (LVEF) was 50%.\n   8. Subjects with serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 50mL/min\n8. The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program\n9. Female subjects should be surgically sterilized or postmenopausal, or agree to use at least one medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment and within 6 months after the end of the study treatment period. The blood pregnancy test must be negative within 7 days before the study, and it must be non-lactation. Male subjects should agree to use at least one medically approved contraceptive method (such as condoms, abstinence, etc.) during the study treatment period and within 6 months after the end of the study treatment period.\n10. Subjects are willing and able to follow the trial and follow-up procedures\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Patients who cannot tolerate radical cystectomy;\n2. patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).\n3. Uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.\n4. Patients with drug allergy or hypersensitivity, patients with autoimmune diseases;\n5. Received antineoplastic therapy within 3 weeks before the start of the study, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and clinical research antineoplastic drug therapy.\n6. Had received live attenuated vaccine or had serious infection or planned to receive any vaccine during the study period one month before entering the group.\n7. Systemic corticosteroids or other systemic immunosuppressive drugs are used within 2 weeks before enrollment, or systemic immunosuppressive drugs are expected to be needed during the trial;\n8. Serovirological examination (based on the normal value of the research center):\n\n   HBsAg or HBcAb test results are positive, while HBVDNA copies are positive; HCVAb test results are positive (only if the PCR test result of HCVRNA is negative).\n\n   The results of HIVAb test were positive.\n9. Heart failure classified as grade 3 or above by the New York College of Cardiology (NYHA);\n10. Active or progressive infections that require systematic treatment, such as active pulmonary tuberculosis;\n11. Systemic diseases that have not been stably controlled by researchers, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.\n12. Serious arteriovenous thrombosis or cardio-cerebrovascular accidents occurred within 1 year before administration, such as deep venous thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., except for lacunar infarction that is asymptomatic and does not require clinical intervention;\n13. Previous allogeneic hematopoietic stem cell transplantation;\n14. Previous antibody-coupled drug therapy;\n15. Pregnant or lactating women.\n16. Suffering from any other disease, abnormal metabolism, abnormal physical examination or abnormal laboratory examination, according to the researchers, there is reason to suspect that the patient has a disease or condition that is not suitable for the use of research drugs, or will affect the interpretation of the results of the study, or put the patient at high risk;\n17. Other situations that some researchers believe are not appropriate to participate in this study.\n\nElimination standard\n\n1. Received other local or systemic treatments at the same time;\n2. The simultaneous use of other foods and drugs that affected the judgment of tolerance; (3) In violation of the requirements of the study scheme, drugs were not given according to the dose and course of treatment specified in the study scheme;\n\n(4) The quality of data recording was poor and the data was incomplete and inaccurate.\n\nTermination criteria\n\n1. Subjects asked to stop using the research therapy.\n2. Recurrence (local, regional or distant).\n3. For any clinical AE, laboratory examination abnormalities or concomitant diseases, according to the judgment of the researchers, continuing to participate in the study is not the greatest benefit to the subjects.\n4. The researcher terminated the study.\n5. The informed consent form can no longer be freely signed because of crime or forcible detention for the treatment of mental illness or physical illness (such as infectious diseases).\n6. The adverse events and severity of other clinical trials of this study or study drugs suggest that the risk of the subjects is too high to continue the study;\n7. The speed of enrollment in the research center is too slow to complete the enrollment plan within a limited time;\n8. The quality of the clinical data is not good enough to continue the follow-up study;\n9. The study is terminated due to the regulatory requirements or policy changes of the national drug administration.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patients with myometrial invasive bladder cancer are prepared for radical cystectomy;",
            "criterions": [
                {
                    "exact_snippets": "Patients with myometrial invasive bladder cancer",
                    "criterion": "myometrial invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prepared for radical cystectomy",
                    "criterion": "preparation for radical cystectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "prepared"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. HER2 overexpression confirmed by pathological biopsy: IHC2+ or IHC3+; subjects can provide tumor samples detected by HER2;",
            "criterions": [
                {
                    "exact_snippets": "HER2 overexpression confirmed by pathological biopsy",
                    "criterion": "HER2 overexpression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathological biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "IHC2+ or IHC3+",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "IHC score",
                            "expected_value": [
                                "IHC2+",
                                "IHC3+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "subjects can provide tumor samples detected by HER2",
                    "criterion": "tumor samples",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "HER2"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Age ≥ 18 years old and ≤ 80 years old;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old and ≤ 80 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Tumor clinical stage is (c) T2-3bN0M0;",
            "criterions": [
                {
                    "exact_snippets": "Tumor clinical stage is (c) T2-3bN0M0",
                    "criterion": "tumor clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "(c) T2-3bN0M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ECOG score ≤ 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG score ≤ 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Subjects have not received systemic chemotherapy, ADC drugs or immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Subjects have not received systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects have not received ... ADC drugs",
                    "criterion": "ADC drugs",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects have not received ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The important laboratory examination indexes meet the following requirements:",
            "criterions": [
                {
                    "exact_snippets": "important laboratory examination indexes",
                    "criterion": "laboratory examination indexes",
                    "requirements": [
                        {
                            "requirement_type": "importance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Hemoglobin ≥ 90g/L.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 90g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L.",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9 / L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Platelet ≥ 100 × 109 / L.",
            "criterions": [
                {
                    "exact_snippets": "Platelet ≥ 100 × 109 / L.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10^9 / L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 3.5mmol/L ≤ serum potassium ≤ 5.5mmol/L.",
            "criterions": [
                {
                    "exact_snippets": "3.5mmol/L ≤ serum potassium ≤ 5.5mmol/L",
                    "criterion": "serum potassium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3.5,
                                        "unit": "mmol/L"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5.5,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Liver function index: ALT, AST ≤ 1.5 times the upper limit of normal value (ULN), TBIL ≤ 1.5ULN.",
            "criterions": [
                {
                    "exact_snippets": "ALT, AST ≤ 1.5 times the upper limit of normal value (ULN)",
                    "criterion": "ALT, AST levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TBIL ≤ 1.5ULN",
                    "criterion": "TBIL level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. eGFR ≥ 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "eGFR ≥ 50 mL/min",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The left ventricular ejection fraction (LVEF) was 50%.",
            "criterions": [
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF) was 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Subjects with serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl) ≥ 50mL/min",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine ≤ 1.5 × ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance rate (CrCl) ≥ 50mL/min",
                    "criterion": "creatinine clearance rate (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program",
            "criterions": [
                {
                    "exact_snippets": "The subject is volunteer to participate",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the subject must signed an informed consent form (ICF)",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating that it understands the purpose of this study and the required procedures",
                    "criterion": "understanding of study purpose and procedures",
                    "requirements": [
                        {
                            "requirement_type": "understanding",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is willing to participate in the study",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must be willing and abide by prohibition and restrictions specified in the research program",
                    "criterion": "compliance with study restrictions",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Female subjects should be surgically sterilized or postmenopausal, or agree to use at least one medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment and within 6 months after the end of the study treatment period. The blood pregnancy test must be negative within 7 days before the study, and it must be non-lactation. Male subjects should agree to use at least one medically approved contraceptive method (such as condoms, abstinence, etc.) during the study treatment period and within 6 months after the end of the study treatment period.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects should be surgically sterilized",
                    "criterion": "female surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects should be ... postmenopausal",
                    "criterion": "female postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects should ... agree to use at least one medically approved contraceptive method",
                    "criterion": "female contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The blood pregnancy test must be negative within 7 days before the study",
                    "criterion": "blood pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "it must be non-lactation",
                    "criterion": "female lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Male subjects should agree to use at least one medically approved contraceptive method",
                    "criterion": "male contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Subjects are willing and able to follow the trial and follow-up procedures",
            "criterions": [
                {
                    "exact_snippets": "Subjects are willing ... to follow the trial and follow-up procedures",
                    "criterion": "willingness to follow procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects are ... able to follow the trial and follow-up procedures",
                    "criterion": "ability to follow procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "allowed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who cannot tolerate radical cystectomy;",
            "criterions": [
                {
                    "exact_snippets": "Patients who cannot tolerate radical cystectomy",
                    "criterion": "tolerance to radical cystectomy",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).",
            "criterions": [
                {
                    "exact_snippets": "patients with myometrial invasive urothelial carcinoma",
                    "criterion": "myometrial invasive urothelial carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal CT scan + enhancement",
                    "criterion": "abdominal CT scan + enhancement",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chest CT scan",
                    "criterion": "chest CT scan",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECT- bone scan",
                    "criterion": "ECT- bone scan",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PET-CT",
                    "criterion": "PET-CT",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI",
                    "criterion": "MRI",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, persistent infection",
                    "criterion": "persistent infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... severe chronic gastrointestinal disease associated with diarrhoea",
                    "criterion": "severe chronic gastrointestinal disease associated with diarrhoea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrollable concomitant diseases, including, but not limited to, ... mental illness / social conditions",
                    "criterion": "mental illness / social conditions",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with drug allergy or hypersensitivity, patients with autoimmune diseases;",
            "criterions": [
                {
                    "exact_snippets": "Patients with drug allergy or hypersensitivity",
                    "criterion": "drug allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Received antineoplastic therapy within 3 weeks before the start of the study, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and clinical research antineoplastic drug therapy.",
            "criterions": [
                {
                    "exact_snippets": "Received antineoplastic therapy within 3 weeks before the start of the study",
                    "criterion": "antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... targeted therapy",
                    "criterion": "targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "including ... clinical research antineoplastic drug therapy",
                    "criterion": "clinical research antineoplastic drug therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Had received live attenuated vaccine or had serious infection or planned to receive any vaccine during the study period one month before entering the group.",
            "criterions": [
                {
                    "exact_snippets": "Had received live attenuated vaccine",
                    "criterion": "live attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had serious infection",
                    "criterion": "serious infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planned to receive any vaccine during the study period",
                    "criterion": "any vaccine",
                    "requirements": [
                        {
                            "requirement_type": "planned receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "one month before entering the group",
                    "criterion": "time before entering the group",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Systemic corticosteroids or other systemic immunosuppressive drugs are used within 2 weeks before enrollment, or systemic immunosuppressive drugs are expected to be needed during the trial;",
            "criterions": [
                {
                    "exact_snippets": "Systemic corticosteroids or other systemic immunosuppressive drugs are used within 2 weeks before enrollment",
                    "criterion": "use of systemic corticosteroids or other systemic immunosuppressive drugs",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks before enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic immunosuppressive drugs are expected to be needed during the trial",
                    "criterion": "need for systemic immunosuppressive drugs",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the trial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Serovirological examination (based on the normal value of the research center):",
            "criterions": [
                {
                    "exact_snippets": "Serovirological examination (based on the normal value of the research center)",
                    "criterion": "serovirological examination",
                    "requirements": [
                        {
                            "requirement_type": "normal value",
                            "expected_value": "based on the research center"
                        }
                    ]
                }
            ]
        },
        {
            "line": "HBsAg or HBcAb test results are positive, while HBVDNA copies are positive; HCVAb test results are positive (only if the PCR test result of HCVRNA is negative).",
            "criterions": [
                {
                    "exact_snippets": "HBsAg or HBcAb test results are positive",
                    "criterion": "HBsAg or HBcAb test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HBVDNA copies are positive",
                    "criterion": "HBVDNA copies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HCVAb test results are positive (only if the PCR test result of HCVRNA is negative)",
                    "criterion": "HCVAb test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "conditional",
                            "expected_value": "only if the PCR test result of HCVRNA is negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "The results of HIVAb test were positive.",
            "criterions": [
                {
                    "exact_snippets": "results of HIVAb test were positive",
                    "criterion": "HIV antibody test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Heart failure classified as grade 3 or above by the New York College of Cardiology (NYHA);",
            "criterions": [
                {
                    "exact_snippets": "Heart failure classified as grade 3 or above by the New York College of Cardiology (NYHA)",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NYHA grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Active or progressive infections that require systematic treatment, such as active pulmonary tuberculosis;",
            "criterions": [
                {
                    "exact_snippets": "Active or progressive infections that require systematic treatment",
                    "criterion": "active or progressive infections",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "systematic treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "active pulmonary tuberculosis",
                    "criterion": "pulmonary tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Systemic diseases that have not been stably controlled by researchers, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.",
            "criterions": [
                {
                    "exact_snippets": "Systemic diseases ... including diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not stably controlled by researchers"
                        }
                    ]
                },
                {
                    "exact_snippets": "Systemic diseases ... including ... hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not stably controlled by researchers"
                        }
                    ]
                },
                {
                    "exact_snippets": "Systemic diseases ... including ... liver cirrhosis",
                    "criterion": "liver cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not stably controlled by researchers"
                        }
                    ]
                },
                {
                    "exact_snippets": "Systemic diseases ... including ... interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not stably controlled by researchers"
                        }
                    ]
                },
                {
                    "exact_snippets": "Systemic diseases ... including ... obstructive pulmonary disease",
                    "criterion": "obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "not stably controlled by researchers"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Serious arteriovenous thrombosis or cardio-cerebrovascular accidents occurred within 1 year before administration, such as deep venous thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., except for lacunar infarction that is asymptomatic and does not require clinical intervention;",
            "criterions": [
                {
                    "exact_snippets": "Serious arteriovenous thrombosis or cardio-cerebrovascular accidents occurred within 1 year before administration",
                    "criterion": "serious arteriovenous thrombosis or cardio-cerebrovascular accidents",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 1 year before administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "lacunar infarction that is asymptomatic and does not require clinical intervention",
                    "criterion": "lacunar infarction",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "clinical intervention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Previous allogeneic hematopoietic stem cell transplantation;",
            "criterions": [
                {
                    "exact_snippets": "Previous allogeneic hematopoietic stem cell transplantation",
                    "criterion": "allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Previous antibody-coupled drug therapy;",
            "criterions": [
                {
                    "exact_snippets": "Previous antibody-coupled drug therapy",
                    "criterion": "antibody-coupled drug therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Pregnant or lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Suffering from any other disease, abnormal metabolism, abnormal physical examination or abnormal laboratory examination, according to the researchers, there is reason to suspect that the patient has a disease or condition that is not suitable for the use of research drugs, or will affect the interpretation of the results of the study, or put the patient at high risk;",
            "criterions": [
                {
                    "exact_snippets": "Suffering from any other disease",
                    "criterion": "other disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal metabolism",
                    "criterion": "abnormal metabolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal physical examination",
                    "criterion": "abnormal physical examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal laboratory examination",
                    "criterion": "abnormal laboratory examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Other situations that some researchers believe are not appropriate to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "Other situations that some researchers believe are not appropriate",
                    "criterion": "appropriateness of participation",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "researcher discretion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Received other local or systemic treatments at the same time;",
            "criterions": [
                {
                    "exact_snippets": "Received other local or systemic treatments",
                    "criterion": "other local or systemic treatments",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The simultaneous use of other foods and drugs that affected the judgment of tolerance; (3) In violation of the requirements of the study scheme, drugs were not given according to the dose and course of treatment specified in the study scheme;",
            "criterions": [
                {
                    "exact_snippets": "The simultaneous use of other foods and drugs that affected the judgment of tolerance",
                    "criterion": "simultaneous use of other foods and drugs",
                    "requirements": [
                        {
                            "requirement_type": "effect on judgment of tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "In violation of the requirements of the study scheme, drugs were not given according to the dose and course of treatment specified in the study scheme",
                    "criterion": "adherence to study scheme",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "(4) The quality of data recording was poor and the data was incomplete and inaccurate.",
            "criterions": [
                {
                    "exact_snippets": "The quality of data recording was poor",
                    "criterion": "data recording quality",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                },
                {
                    "exact_snippets": "the data was incomplete",
                    "criterion": "data completeness",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "the data was ... inaccurate",
                    "criterion": "data accuracy",
                    "requirements": [
                        {
                            "requirement_type": "accuracy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Termination criteria",
            "criterions": [
                {
                    "exact_snippets": "Termination criteria",
                    "criterion": "termination criteria",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Subjects asked to stop using the research therapy.",
            "criterions": [
                {
                    "exact_snippets": "Subjects asked to stop using the research therapy.",
                    "criterion": "use of research therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Recurrence (local, regional or distant).",
            "criterions": [
                {
                    "exact_snippets": "Recurrence (local, regional or distant)",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "local",
                                "regional",
                                "distant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. For any clinical AE, laboratory examination abnormalities or concomitant diseases, according to the judgment of the researchers, continuing to participate in the study is not the greatest benefit to the subjects.",
            "criterions": [
                {
                    "exact_snippets": "clinical AE",
                    "criterion": "clinical adverse events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not the greatest benefit to the subjects"
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory examination abnormalities",
                    "criterion": "laboratory examination abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not the greatest benefit to the subjects"
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitant diseases",
                    "criterion": "concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not the greatest benefit to the subjects"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The informed consent form can no longer be freely signed because of crime or forcible detention for the treatment of mental illness or physical illness (such as infectious diseases).",
            "criterions": [
                {
                    "exact_snippets": "crime",
                    "criterion": "crime",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "forcible detention",
                    "criterion": "forcible detention",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of mental illness",
                    "criterion": "treatment of mental illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of ... physical illness (such as infectious diseases)",
                    "criterion": "treatment of physical illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The adverse events and severity of other clinical trials of this study or study drugs suggest that the risk of the subjects is too high to continue the study;",
            "criterions": [
                {
                    "exact_snippets": "adverse events and severity of other clinical trials",
                    "criterion": "adverse events and severity",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "too high to continue the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The speed of enrollment in the research center is too slow to complete the enrollment plan within a limited time;",
            "criterions": [
                {
                    "exact_snippets": "speed of enrollment in the research center is too slow",
                    "criterion": "enrollment speed",
                    "requirements": [
                        {
                            "requirement_type": "speed",
                            "expected_value": "too slow"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. The quality of the clinical data is not good enough to continue the follow-up study;",
            "criterions": [
                {
                    "exact_snippets": "The quality of the clinical data is not good enough",
                    "criterion": "clinical data quality",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good enough"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Elimination standard",
            "criterions": []
        },
        {
            "line": "4. The researcher terminated the study.",
            "criterions": []
        },
        {
            "line": "9. The study is terminated due to the regulatory requirements or policy changes of the national drug administration.",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}