{
    "info": {
        "nct_id": "NCT05767060",
        "official_title": "A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients with Advanced Malignant Tumors.",
        "inclusion_criteria": "1. Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;\n2. The investigator evaluated the expected survival period to be at least 3 months;\n3. The requirement of the ECOG physical fitness score is 0 or 1;\n4. Patients with advanced malignant tumors who have failed to receive standard treatment, have no standard treatment, do not tolerate standard treatment or refuse to accept standard treatment confirmed by cytology or pathology;\n5. There must be an evaluable tumor focus in the dose increasing stage, and at least one measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);\n6. It has sufficient organ and bone marrow reserve function, which is defined as follows:\n\n   System laboratory reference value:\n\n   Blood routine (no blood transfusion, no use of hematopoietic stimulating factor and no use of drugs to correct blood cell count within 14 days before the first administration):\n\n   Absolute neutrophil count ≥ 1.5 x 109/L;Platelet count ≥ 90 x109/L;Hemoglobin ≥ 90g/L;\n\n   Coagulation function:\n\n   International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5xULN (without anticoagulant treatment), those who receive oral anticoagulant treatment and whose INR is 2~3 can be included.\n\n   Liver function:\n\n   Total bilirubin (TBIL) ≤ 1.5xULN;Hepatocellular carcinoma, Gilbert's syndrome, liver metastasis ≤ 2xULN;Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5xULN;Hepatocellular carcinoma, liver metastasis ≤ 5xULN renal function Serum creatinine or Serum creatinine clearance ≤ 1.5xULN or>50ml/min (using Cockcroft-Gault formula, see appendix)\n7. Agree to provide archived pathological tissue or fresh biopsy tumor tissue for the detection of PD-L1, CD47 expression level or receptor occupancy and other pharmacodynamic indicators (not as a necessary inclusion standard); Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration and are willing to take effective birth control/contraception methods to prevent pregnancy during the study period until 6 months after the last administration of the study. Male patients must agree to take effective contraceptive methods during the study period and within 6 months after the last administration of the study; Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "1. Have received any anti-CD47 antibody and SIRP within 4 weeks before the first administration α Antibodies or CD47/SIRP α Recombinant protein therapy;\n2. He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, with the exception of the following: ① nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); ③ The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug;\n3. Those who are participating in or have participated in the experimental drug or medical device intervention clinical research within 4 weeks before the first administration of this study cannot be included; In the survival follow-up stage of the intervention study, if the time between the first administration and the end of the previous study (the last administration) meets the above exclusion criteria, it can be included;\n4. Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4 weeks before screening;\n5. Pregnant or lactating women;\n6. AEs caused by previous anti-tumor therapy are still higher than grade 1 (based on CTCAE v5.0) before the first administration of the study drug (except for AEs such as hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stable for a long time according to the judgment of the researcher based on clinical actual conditions, except for grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy);\n7. Those who have had ≥ 3 levels of irAE in the past or have terminated immunotherapy due to any level of irAE;\n8. Primary central nervous system tumor, central nervous system metastasis with related symptoms, meningeal metastasis or previous history of epilepsy should be excluded. Patients with asymptomatic or asymptomatic central nervous system metastasis who have been clinically controlled but have been judged stable by the researcher can be included, but the following conditions must be met at the same time: a The disease was stable ≥ 4 weeks before the first administration; B. No evidence of central nervous system disease progression was found in MRI enhancement of the head within 4 weeks before the first administration; C. The anticonvulsant drugs have been stopped at least 2 weeks before the first administration, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone;\n9. Patients who have undergone major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial period;\n10. Have a history of tissue or organ transplantation;\n11. Patients with severe infection within 4 weeks before the first medication, including but not limited to infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization; Patients with active infection before the first administration were excluded;\n12. Known history of human immunodeficiency virus (HIV) infection;\n13. Active hepatitis B, untreated chronic hepatitis B or treated but uncontrolled chronic hepatitis B (HBV DNA>200 IU/mL or>103 copies/ml);\n14. Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);\n15. Untreated or under treatment tuberculosis patients, including but not limited to tuberculosis; Those who have received standard anti-tuberculosis treatment and have been confirmed as cured by researchers can be included;\n16. Known to have a history of severe allergy, or known to have had ≥ grade 3 allergic reaction to macromolecular protein preparation/monoclonal antibody, and any component of test drug;\n17. Patients with active, or had a history of autoimmune diseases that may recur (excluding vitiligo, autoimmune thyroid diseases that can be treated with hormone replacement therapy, and type 1 diabetes patients);\n18. Have received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of the same drug) or other immunosuppressive treatment within 14 days before the first use of the study drug, except for the following cases: ① use of local, ocular, intraarticular, intranasal and inhaled glucocorticoid treatment, ② short-term use of glucocorticoid for preventive treatment (such as prevention of contrast agent allergy);\n19. Patients who have a history of non-infectious pneumonia requiring glucocorticoid treatment or who currently have interstitial lung disease within 1 year before the first administration;\n20. There is a history of serious cardio-cerebrovascular disease, including but not limited to: ① heart failure or left ventricular ejection fraction (LVEF)<50% with NYHA grade II or above; ② There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, Ⅱ - Ⅲ degree atrioventricular block, etc.; ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration; ④ Hypertension that cannot be controlled clinically (this protocol is defined as that although antihypertensive treatment is adopted, the systolic blood pressure is more than 150 mmHg and/or diastolic blood pressure is more than 100 mmHg after treatment, and has clinical significance after evaluation by the researcher);\n21. Those with the following risk of thrombosis or bleeding:\n\n    A. Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before the first administration; B. There is a history of deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before the first administration (implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered as \"serious\" thromboembolism); C. Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopy or surgical treatment within 3 months before the first administration; D. Other diseases that the researcher believes have a high risk of bleeding or thrombosis in the future;\n22. Patients who are known to have a history of abuse or drug abuse of psychotropic substances and are considered to affect the compliance of this study;\n23. Have a history of hemolytic anemia or Evans syndrome in the past 3 months;\n24. In addition to the tumors at the time of study, there are other active malignant tumors within 3 years before the first administration (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer cancer or breast cancer in situ);\n25. Patients with pleural effusion, pericardial effusion or ascites that are not controlled or need drainage;\n26. Patients who are not suitable for this study according to the researcher.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;",
            "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"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "gender: male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. The investigator evaluated the expected survival period to be at least 3 months;",
            "criterions": [
                {
                    "exact_snippets": "expected survival period to be at least 3 months",
                    "criterion": "expected survival period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. The requirement of the ECOG physical fitness score is 0 or 1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG physical fitness score is 0 or 1",
                    "criterion": "ECOG physical fitness score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients with advanced malignant tumors who have failed to receive standard treatment, have no standard treatment, do not tolerate standard treatment or refuse to accept standard treatment confirmed by cytology or pathology;",
            "criterions": [
                {
                    "exact_snippets": "advanced malignant tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        },
                        {
                            "requirement_type": "malignancy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "failed to receive standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "failure to receive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "do not tolerate standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "refuse to accept standard treatment",
                    "criterion": "standard treatment",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by cytology or pathology",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "cytology",
                                "pathology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. There must be an evaluable tumor focus in the dose increasing stage, and at least one measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);",
            "criterions": [
                {
                    "exact_snippets": "evaluable tumor focus in the dose increasing stage",
                    "criterion": "tumor focus in the dose increasing stage",
                    "requirements": [
                        {
                            "requirement_type": "evaluable",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one measurable tumor focus in the dose expanding stage",
                    "criterion": "tumor focus in the dose expanding stage",
                    "requirements": [
                        {
                            "requirement_type": "measurable",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "focus"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. It has sufficient organ and bone marrow reserve function, which is defined as follows:",
            "criterions": [
                {
                    "exact_snippets": "sufficient organ and bone marrow reserve function",
                    "criterion": "organ and bone marrow reserve function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "System laboratory reference value:",
            "criterions": [
                {
                    "exact_snippets": "System laboratory reference value",
                    "criterion": "laboratory reference value",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "system"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Blood routine (no blood transfusion, no use of hematopoietic stimulating factor and no use of drugs to correct blood cell count within 14 days before the first administration):",
            "criterions": [
                {
                    "exact_snippets": "Blood routine",
                    "criterion": "blood routine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no blood transfusion ... within 14 days before the first administration",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no use of hematopoietic stimulating factor ... within 14 days before the first administration",
                    "criterion": "hematopoietic stimulating factor",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no use of drugs to correct blood cell count ... within 14 days before the first administration",
                    "criterion": "drugs to correct blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Absolute neutrophil count ≥ 1.5 x 109/L;Platelet count ≥ 90 x109/L;Hemoglobin ≥ 90g/L;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1.5 x 109/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count ≥ 90 x109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "x109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin ≥ 90g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Coagulation function:",
            "criterions": [
                {
                    "exact_snippets": "Coagulation function",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "International standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5xULN (without anticoagulant treatment), those who receive oral anticoagulant treatment and whose INR is 2~3 can be included.",
            "criterions": [
                {
                    "exact_snippets": "International standardized ratio (INR) ... ≤ 1.5xULN (without anticoagulant treatment)",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "xULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time (APTT) ≤ 1.5xULN (without anticoagulant treatment)",
                    "criterion": "APTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "xULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "those who receive oral anticoagulant treatment and whose INR is 2~3",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": ""
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": ""
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Liver function:",
            "criterions": [
                {
                    "exact_snippets": "Liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Total bilirubin (TBIL) ≤ 1.5xULN;Hepatocellular carcinoma, Gilbert's syndrome, liver metastasis ≤ 2xULN;Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5xULN;Hepatocellular carcinoma, liver metastasis ≤ 5xULN renal function Serum creatinine or Serum creatinine clearance ≤ 1.5xULN or>50ml/min (using Cockcroft-Gault formula, see appendix)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin (TBIL) ≤ 1.5xULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "xULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatocellular carcinoma, Gilbert's syndrome, liver metastasis ≤ 2xULN",
                    "criterion": "bilirubin level in specific conditions",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "xULN"
                            }
                        },
                        {
                            "requirement_type": "conditions",
                            "expected_value": [
                                "Hepatocellular carcinoma",
                                "Gilbert's syndrome",
                                "liver metastasis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5xULN",
                    "criterion": "alanine aminotransferase and aspartate aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "xULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatocellular carcinoma, liver metastasis ≤ 5xULN",
                    "criterion": "aminotransferase level in specific conditions",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "xULN"
                            }
                        },
                        {
                            "requirement_type": "conditions",
                            "expected_value": [
                                "Hepatocellular carcinoma",
                                "liver metastasis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine or Serum creatinine clearance ≤ 1.5xULN or>50ml/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "serum creatinine level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "xULN"
                            }
                        },
                        {
                            "requirement_type": "serum creatinine clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Agree to provide archived pathological tissue or fresh biopsy tumor tissue for the detection of PD-L1, CD47 expression level or receptor occupancy and other pharmacodynamic indicators (not as a necessary inclusion standard); Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration and are willing to take effective birth control/contraception methods to prevent pregnancy during the study period until 6 months after the last administration of the study. Male patients must agree to take effective contraceptive methods during the study period and within 6 months after the last administration of the study; Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.",
            "criterions": [
                {
                    "exact_snippets": "archived pathological tissue or fresh biopsy tumor tissue",
                    "criterion": "tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "archived pathological",
                                "fresh biopsy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "detection of PD-L1, CD47 expression level or receptor occupancy and other pharmacodynamic indicators",
                    "criterion": "biomarker detection",
                    "requirements": [
                        {
                            "requirement_type": "biomarkers",
                            "expected_value": [
                                "PD-L1",
                                "CD47",
                                "receptor occupancy",
                                "other pharmacodynamic indicators"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients with fertility must have negative serum pregnancy test within 7 days before the first administration",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female patients with fertility ... are willing to take effective birth control/contraception methods to prevent pregnancy during the study period until 6 months after the last administration",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period until 6 months after the last administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male patients must agree to take effective contraceptive methods during the study period and within 6 months after the last administration",
                    "criterion": "male contraception",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and within 6 months after the last administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "amenorrhea duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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. Have received any anti-CD47 antibody and SIRP within 4 weeks before the first administration α Antibodies or CD47/SIRP α Recombinant protein therapy;",
            "criterions": [
                {
                    "exact_snippets": "Have received any anti-CD47 antibody",
                    "criterion": "anti-CD47 antibody",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Have received any ... SIRP",
                    "criterion": "SIRP",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CD47/SIRP α Recombinant protein therapy",
                    "criterion": "CD47/SIRP α Recombinant protein therapy",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, with the exception of the following: ① nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); ③ The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug",
                    "criterion": "prior anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "nitrosourea or mitomycin C within 6 weeks before the first use of the study drug",
                    "criterion": "nitrosourea or mitomycin C treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer)",
                    "criterion": "Oral fluorouracil and small-molecule targeted drugs",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": "2 weeks or within 5 half-lives of the drug (whichever is longer)"
                        }
                    ]
                },
                {
                    "exact_snippets": "The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug",
                    "criterion": "systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Those who are participating in or have participated in the experimental drug or medical device intervention clinical research within 4 weeks before the first administration of this study cannot be included; In the survival follow-up stage of the intervention study, if the time between the first administration and the end of the previous study (the last administration) meets the above exclusion criteria, it can be included;",
            "criterions": [
                {
                    "exact_snippets": "participating in or have participated in the experimental drug or medical device intervention clinical research within 4 weeks before the first administration",
                    "criterion": "participation in experimental drug or medical device intervention clinical research",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4 weeks before screening;",
            "criterions": [
                {
                    "exact_snippets": "Inoculated or planned to receive live/attenuated vaccine",
                    "criterion": "live/attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "inoculation status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inoculated or planned to receive ... mRNA vaccine",
                    "criterion": "mRNA vaccine",
                    "requirements": [
                        {
                            "requirement_type": "inoculation status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks before screening",
                    "criterion": "time since vaccination",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. 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": "6. AEs caused by previous anti-tumor therapy are still higher than grade 1 (based on CTCAE v5.0) before the first administration of the study drug (except for AEs such as hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stable for a long time according to the judgment of the researcher based on clinical actual conditions, except for grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy);",
            "criterions": [
                {
                    "exact_snippets": "AEs caused by previous anti-tumor therapy are still higher than grade 1 (based on CTCAE v5.0)",
                    "criterion": "adverse events from previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade (CTCAE v5.0)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AEs such as hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stable for a long time",
                    "criterion": "hair loss and fatigue",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "cannot be restored to ≤ grade 1 and will remain stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 2 peripheral neurotoxicity",
                    "criterion": "peripheral neurotoxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hypothyroidism stabilized by hormone replacement therapy",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stabilized by hormone replacement therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Those who have had ≥ 3 levels of irAE in the past or have terminated immunotherapy due to any level of irAE;",
            "criterions": [
                {
                    "exact_snippets": "have had ≥ 3 levels of irAE in the past",
                    "criterion": "irAE levels in the past",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "levels"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have terminated immunotherapy due to any level of irAE",
                    "criterion": "termination of immunotherapy due to irAE",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "any level of irAE"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Primary central nervous system tumor, central nervous system metastasis with related symptoms, meningeal metastasis or previous history of epilepsy should be excluded. Patients with asymptomatic or asymptomatic central nervous system metastasis who have been clinically controlled but have been judged stable by the researcher can be included, but the following conditions must be met at the same time: a The disease was stable ≥ 4 weeks before the first administration; B. No evidence of central nervous system disease progression was found in MRI enhancement of the head within 4 weeks before the first administration; C. The anticonvulsant drugs have been stopped at least 2 weeks before the first administration, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone;",
            "criterions": [
                {
                    "exact_snippets": "Primary central nervous system tumor",
                    "criterion": "primary central nervous system tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "central nervous system metastasis with related symptoms",
                    "criterion": "central nervous system metastasis with related symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "meningeal metastasis",
                    "criterion": "meningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous history of epilepsy",
                    "criterion": "previous history of epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic or asymptomatic central nervous system metastasis",
                    "criterion": "asymptomatic central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The disease was stable ≥ 4 weeks before the first administration",
                    "criterion": "disease stability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of central nervous system disease progression was found in MRI enhancement of the head within 4 weeks before the first administration",
                    "criterion": "central nervous system disease progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The anticonvulsant drugs have been stopped at least 2 weeks before the first administration",
                    "criterion": "anticonvulsant drug use",
                    "requirements": [
                        {
                            "requirement_type": "cessation duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone",
                    "criterion": "prednisone dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients who have undergone major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial period;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone major organ surgery (excluding puncture biopsy) ... within 4 weeks before the first use of the study drug",
                    "criterion": "major organ surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who ... had significant trauma within 4 weeks before the first use of the study drug",
                    "criterion": "significant trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since trauma",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients ... who need to undergo elective surgery during the trial period",
                    "criterion": "elective surgery",
                    "requirements": [
                        {
                            "requirement_type": "need for surgery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Have a history of tissue or organ transplantation;",
            "criterions": [
                {
                    "exact_snippets": "history of tissue or organ transplantation",
                    "criterion": "tissue or organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with severe infection within 4 weeks before the first medication, including but not limited to infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization; Patients with active infection before the first administration were excluded;",
            "criterions": [
                {
                    "exact_snippets": "severe infection within 4 weeks before the first medication",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks before the first medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization",
                    "criterion": "infection complications",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring hospitalization"
                        }
                    ]
                },
                {
                    "exact_snippets": "infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization",
                    "criterion": "bacteremia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring hospitalization"
                        }
                    ]
                },
                {
                    "exact_snippets": "infection complications, bacteremia, severe pneumonia, etc. requiring hospitalization",
                    "criterion": "severe pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring hospitalization"
                        }
                    ]
                },
                {
                    "exact_snippets": "active infection before the first administration",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known history of human immunodeficiency virus (HIV) infection;",
            "criterions": [
                {
                    "exact_snippets": "Known history of human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Active hepatitis B, untreated chronic hepatitis B or treated but uncontrolled chronic hepatitis B (HBV DNA>200 IU/mL or>103 copies/ml);",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "treated but uncontrolled chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        },
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV DNA>200 IU/mL",
                    "criterion": "HBV DNA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 200,
                                "unit": "IU/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": ">103 copies/ml",
                    "criterion": "HBV DNA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 103,
                                "unit": "copies/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);",
            "criterions": [
                {
                    "exact_snippets": "Active HCV infected patients (HCV antibody positive",
                    "criterion": "HCV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV-RNA level higher than the lower limit of detection",
                    "criterion": "HCV-RNA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower limit of detection"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Untreated or under treatment tuberculosis patients, including but not limited to tuberculosis; Those who have received standard anti-tuberculosis treatment and have been confirmed as cured by researchers can be included;",
            "criterions": [
                {
                    "exact_snippets": "Untreated or under treatment tuberculosis patients",
                    "criterion": "tuberculosis treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "untreated",
                                "under treatment"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Those who have received standard anti-tuberculosis treatment and have been confirmed as cured by researchers",
                    "criterion": "tuberculosis treatment outcome",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "cured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Known to have a history of severe allergy, or known to have had ≥ grade 3 allergic reaction to macromolecular protein preparation/monoclonal antibody, and any component of test drug;",
            "criterions": [
                {
                    "exact_snippets": "Known to have a history of severe allergy",
                    "criterion": "history of severe allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known to have had ≥ grade 3 allergic reaction to macromolecular protein preparation/monoclonal antibody",
                    "criterion": "allergic reaction to macromolecular protein preparation/monoclonal antibody",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "known to have had ≥ grade 3 allergic reaction to ... any component of test drug",
                    "criterion": "allergic reaction to any component of test drug",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients with active, or had a history of autoimmune diseases that may recur (excluding vitiligo, autoimmune thyroid diseases that can be treated with hormone replacement therapy, and type 1 diabetes patients);",
            "criterions": [
                {
                    "exact_snippets": "Patients with active, or had a history of autoimmune diseases that may recur",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "history"
                            ]
                        },
                        {
                            "requirement_type": "recurrence potential",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding vitiligo",
                    "criterion": "vitiligo",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... autoimmune thyroid diseases that can be treated with hormone replacement therapy",
                    "criterion": "autoimmune thyroid diseases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement therapy"
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... type 1 diabetes patients",
                    "criterion": "type 1 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Have received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of the same drug) or other immunosuppressive treatment within 14 days before the first use of the study drug, except for the following cases: ① use of local, ocular, intraarticular, intranasal and inhaled glucocorticoid treatment, ② short-term use of glucocorticoid for preventive treatment (such as prevention of contrast agent allergy);",
            "criterions": [
                {
                    "exact_snippets": "Have received systemic glucocorticoid (prednisone>10mg/day or equivalent dose of the same drug)",
                    "criterion": "systemic glucocorticoid",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive treatment within 14 days before the first use of the study drug",
                    "criterion": "immunosuppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 14 days before the first use of the study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Patients who have a history of non-infectious pneumonia requiring glucocorticoid treatment or who currently have interstitial lung disease within 1 year before the first administration;",
            "criterions": [
                {
                    "exact_snippets": "history of non-infectious pneumonia requiring glucocorticoid treatment",
                    "criterion": "non-infectious pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "glucocorticoid"
                        }
                    ]
                },
                {
                    "exact_snippets": "currently have interstitial lung disease within 1 year before the first administration",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 1 year before the first administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. There is a history of serious cardio-cerebrovascular disease, including but not limited to: ① heart failure or left ventricular ejection fraction (LVEF)<50% with NYHA grade II or above; ② There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, Ⅱ - Ⅲ degree atrioventricular block, etc.; ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration; ④ Hypertension that cannot be controlled clinically (this protocol is defined as that although antihypertensive treatment is adopted, the systolic blood pressure is more than 150 mmHg and/or diastolic blood pressure is more than 100 mmHg after treatment, and has clinical significance after evaluation by the researcher);",
            "criterions": [
                {
                    "exact_snippets": "history of serious cardio-cerebrovascular disease",
                    "criterion": "cardio-cerebrovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction (LVEF)<50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "NYHA grade II or above",
                    "criterion": "NYHA grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious cardiac rhythm or conduction abnormalities",
                    "criterion": "cardiac rhythm or conduction abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia requiring clinical intervention",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "intervention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Ⅱ - Ⅲ degree atrioventricular block",
                    "criterion": "atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "degree"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Acute coronary syndrome",
                    "criterion": "acute coronary syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aortic dissection",
                    "criterion": "aortic dissection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiovascular and cerebrovascular events of grade 3 or above",
                    "criterion": "cardiovascular and cerebrovascular events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "occurred within 6 months before the first administration",
                    "criterion": "time since cardiovascular and cerebrovascular events",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hypertension that cannot be controlled clinically",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure is more than 150 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure is more than 100 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Those with the following risk of thrombosis or bleeding:",
            "criterions": [
                {
                    "exact_snippets": "risk of thrombosis",
                    "criterion": "thrombosis risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "risk of ... bleeding",
                    "criterion": "bleeding risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "A. Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before the first administration; B. There is a history of deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before the first administration (implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered as \"serious\" thromboembolism); C. Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopy or surgical treatment within 3 months before the first administration; D. Other diseases that the researcher believes have a high risk of bleeding or thrombosis in the future;",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before the first administration",
                    "criterion": "cardiovascular events",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before the first administration",
                    "criterion": "thromboembolism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/variceal bleeding event requiring blood transfusion, endoscopy or surgical treatment within 3 months before the first administration",
                    "criterion": "bleeding events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "life-threatening",
                                "grade 3",
                                "grade 4"
                            ]
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "blood transfusion",
                                "endoscopy",
                                "surgical treatment"
                            ]
                        },
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Other diseases that the researcher believes have a high risk of bleeding or thrombosis in the future",
                    "criterion": "risk of bleeding or thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Patients who are known to have a history of abuse or drug abuse of psychotropic substances and are considered to affect the compliance of this study;",
            "criterions": [
                {
                    "exact_snippets": "Patients who are known to have a history of abuse or drug abuse of psychotropic substances",
                    "criterion": "history of abuse or drug abuse of psychotropic substances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered to affect the compliance of this study",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "affect the compliance of this study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Have a history of hemolytic anemia or Evans syndrome in the past 3 months;",
            "criterions": [
                {
                    "exact_snippets": "history of hemolytic anemia",
                    "criterion": "hemolytic anemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... Evans syndrome",
                    "criterion": "Evans syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. In addition to the tumors at the time of study, there are other active malignant tumors within 3 years before the first administration (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer cancer or breast cancer in situ);",
            "criterions": [
                {
                    "exact_snippets": "other active malignant tumors within 3 years before the first administration",
                    "criterion": "active malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 years before the first administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer cancer or breast cancer in situ",
                    "criterion": "locally cured tumors",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "skin basal cell carcinoma",
                                "superficial bladder cancer",
                                "breast cancer in situ"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "25. Patients with pleural effusion, pericardial effusion or ascites that are not controlled or need drainage;",
            "criterions": [
                {
                    "exact_snippets": "pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "drainage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "drainage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "drainage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "26. Patients who are not suitable for this study according to the researcher.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are not suitable for this study according to the researcher.",
                    "criterion": "suitability for study",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "according to the researcher"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}