{
    "info": {
        "nct_id": "NCT06420973",
        "official_title": "A Single-arm, Multicenter, Phase II Study of RC48 Plus Platinum With or Without Bevacizumab in the Treatment of HER-2 Expression Platinum-Sensitive Recurrent Ovarian Cancer",
        "inclusion_criteria": "* Female subjects aged from 18 to 75 years old;\n* Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma;\n* Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenance therapy after complete clinical or pathological response;Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;\n* Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);\n* Estimated life expectancy of more than 3 months;\n* Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+; Subjects were able to provide samples of the primary or metastatic site of the tumor for HER2 detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ）\n* Adequate haematological, hepatic and renal functions defined by the protocol;\n* Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for female subjects if the risk of conception exists;\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer or metastatic ovarian cancer;\n* The patient has ≥ grade 2 peripheral neuropathy;\n* Patients with active bleeding or pathological conditions with high risk of bleeding, such as known hemorrhagic diseases, coagulation disorders, or tumors involving large blood vessels;\n* Suffering from central nervous system metastasis and/or cancerous meningitis. Except for stable brain metastases; 5.The toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) level 0-1 (excluding 2nd degree hair loss);\n* Patients who require parenteral hydration or nutrition and have evidence of partial intestinal obstruction or perforation;\n* Except for patients with primary endometrial cancer or a history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-B stage; No more than superficial muscle infiltration, no vascular or lymphatic infiltration; No poorly differentiated subtypes, including papillary fluid, clear cells, or other FIGO grade 3 lesions;\n* For patients undergoing cell reduction surgery before treatment, if combined with bevacizumab, they must wait for at least 28 days before starting the treatment with bevacizumab;\n* Have undergone major surgery within 4 weeks prior to the start of study administration and have not fully recovered;\n* A large amount of pleural or ascitic fluid accompanied by clinical symptoms or requiring symptomatic treatment;\n* Within 30 days of initial medication or expected to receive attenuated live vaccines during the study period;\n* Serious arterial/venous thrombotic events or cardiovascular and cerebrovascular accidents that occurred within one year prior to drug administration were studied;\n* There are systemic diseases that have not been controlled stably according to the judgment of the researcher, including diabetes, liver cirrhosis (Child Pugh Class B or C), interstitial pneumonia, obstructive pulmonary disease, etc;\n* Clinically significant cardiovascular disease patients(According to the specific requirements of the plan);\n* Individuals with active autoimmune diseases or immunodeficiency, or a history of the aforementioned conditions, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc., shall not be included. The following exceptions apply: Patients with a history of autoimmune hypothyroidism who have received thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar can be controlled after treatment with insulin administration scheme can participate in this study;\n* Subjects with a history of other malignant tumors within five years (excluding complete treatment for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma skin cancer);\n* Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 2000 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;\n* Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (>38.5%) of unknown reason occurred during the screening period/before the first administration；\n* Currently participating in intervention clinical research treatment, or receiving other investigational drugs or research instruments within 4 weeks prior to the first administration; Not fully recovered from toxicity and/or complications caused by any intervention measures prior to initial administration (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss);\n* Has a clear history of allergies and may have potential allergies or intolerance to the investigational drug and its similar biological agents;\n* Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female subjects aged from 18 to 75 years old;",
            "criterions": [
                {
                    "exact_snippets": "Female subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged from 18 to 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma;",
            "criterions": [
                {
                    "exact_snippets": "Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma",
                    "criterion": "primary epithelial ovarian/fallopian tube/peritoneal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenance therapy after complete clinical or pathological response;Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment lines ≥1 and ≤4",
                    "criterion": "previous treatment lines",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "first-line treatment may include maintenance therapy after complete clinical or pathological response",
                    "criterion": "first-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "may include maintenance therapy after complete clinical or pathological response"
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)",
                    "criterion": "targeted HER2 drug therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);",
            "criterions": [
                {
                    "exact_snippets": "Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy of more than 3 months;",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy of more than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+; Subjects were able to provide samples of the primary or metastatic site of the tumor for HER2 detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ）",
            "criterions": [
                {
                    "exact_snippets": "Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+",
                    "criterion": "HER2 expression",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "IHC score",
                            "expected_value": [
                                "1+",
                                "2+",
                                "3+"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects were able to provide samples of the primary or metastatic site of the tumor for HER2 detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ）",
                    "criterion": "tumor sample provision",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "sample type",
                            "expected_value": [
                                "Paraffin blocks",
                                "paraffin embedded sections",
                                "fresh tissue sections"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate haematological, hepatic and renal functions defined by the protocol;",
            "criterions": [
                {
                    "exact_snippets": "Adequate haematological ... functions",
                    "criterion": "haematological functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "defined by the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... hepatic ... functions",
                    "criterion": "hepatic functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "defined by the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal functions",
                    "criterion": "renal functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "defined by the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for female subjects if the risk of conception exists;",
            "criterions": [
                {
                    "exact_snippets": "Negative blood pregnancy test at Screening for women of childbearing potential",
                    "criterion": "blood pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Highly effective contraception for female subjects if the risk of conception exists",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer or metastatic ovarian cancer;",
            "criterions": [
                {
                    "exact_snippets": "The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer",
                    "criterion": "pathological type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non epithelial ovarian/fallopian tube/peritoneal cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "The pathological type is ... metastatic ovarian cancer",
                    "criterion": "pathological type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic ovarian cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient has ≥ grade 2 peripheral neuropathy;",
            "criterions": [
                {
                    "exact_snippets": "≥ grade 2 peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active bleeding or pathological conditions with high risk of bleeding, such as known hemorrhagic diseases, coagulation disorders, or tumors involving large blood vessels;",
            "criterions": [
                {
                    "exact_snippets": "active bleeding",
                    "criterion": "active bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological conditions with high risk of bleeding",
                    "criterion": "pathological conditions with high risk of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known hemorrhagic diseases",
                    "criterion": "hemorrhagic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulation disorders",
                    "criterion": "coagulation disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors involving large blood vessels",
                    "criterion": "tumors involving large blood vessels",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suffering from central nervous system metastasis and/or cancerous meningitis. Except for stable brain metastases; 5.The toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) level 0-1 (excluding 2nd degree hair loss);",
            "criterions": [
                {
                    "exact_snippets": "Suffering from central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancerous meningitis",
                    "criterion": "cancerous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable brain metastases",
                    "criterion": "stable brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) level 0-1",
                    "criterion": "toxicity recovery",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "CTCAE level"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding 2nd degree hair loss",
                    "criterion": "2nd degree hair loss",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who require parenteral hydration or nutrition and have evidence of partial intestinal obstruction or perforation;",
            "criterions": [
                {
                    "exact_snippets": "Patients who require parenteral hydration or nutrition",
                    "criterion": "parenteral hydration or nutrition",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of partial intestinal obstruction",
                    "criterion": "partial intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of ... perforation",
                    "criterion": "intestinal perforation",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Except for patients with primary endometrial cancer or a history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-B stage; No more than superficial muscle infiltration, no vascular or lymphatic infiltration; No poorly differentiated subtypes, including papillary fluid, clear cells, or other FIGO grade 3 lesions;",
            "criterions": [
                {
                    "exact_snippets": "primary endometrial cancer",
                    "criterion": "primary endometrial cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "stage not greater than I-B stage",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.1,
                                "unit": "FIGO stage"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No more than superficial muscle infiltration",
                    "criterion": "muscle infiltration",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "superficial"
                        }
                    ]
                },
                {
                    "exact_snippets": "no vascular or lymphatic infiltration",
                    "criterion": "vascular or lymphatic infiltration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No poorly differentiated subtypes, including papillary fluid, clear cells, or other FIGO grade 3 lesions",
                    "criterion": "differentiation subtype",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "well differentiated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients undergoing cell reduction surgery before treatment, if combined with bevacizumab, they must wait for at least 28 days before starting the treatment with bevacizumab;",
            "criterions": [
                {
                    "exact_snippets": "patients undergoing cell reduction surgery before treatment, if combined with bevacizumab, they must wait for at least 28 days before starting the treatment with bevacizumab",
                    "criterion": "waiting period after cell reduction surgery",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have undergone major surgery within 4 weeks prior to the start of study administration and have not fully recovered;",
            "criterions": [
                {
                    "exact_snippets": "Have undergone major surgery within 4 weeks prior to the start of study administration",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "have not fully recovered",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A large amount of pleural or ascitic fluid accompanied by clinical symptoms or requiring symptomatic treatment;",
            "criterions": [
                {
                    "exact_snippets": "A large amount of pleural or ascitic fluid",
                    "criterion": "pleural or ascitic fluid",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "large"
                        }
                    ]
                },
                {
                    "exact_snippets": "accompanied by clinical symptoms",
                    "criterion": "clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring symptomatic treatment",
                    "criterion": "symptomatic treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Within 30 days of initial medication or expected to receive attenuated live vaccines during the study period;",
            "criterions": [
                {
                    "exact_snippets": "Within 30 days of initial medication",
                    "criterion": "time since initial medication",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected to receive attenuated live vaccines during the study period",
                    "criterion": "receipt of attenuated live vaccines",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious arterial/venous thrombotic events or cardiovascular and cerebrovascular accidents that occurred within one year prior to drug administration were studied;",
            "criterions": [
                {
                    "exact_snippets": "Serious arterial/venous thrombotic events",
                    "criterion": "arterial/venous thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within one year prior to drug administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiovascular and cerebrovascular accidents",
                    "criterion": "cardiovascular and cerebrovascular accidents",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within one year prior to drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There are systemic diseases that have not been controlled stably according to the judgment of the researcher, including diabetes, liver cirrhosis (Child Pugh Class B or C), interstitial pneumonia, obstructive pulmonary disease, etc;",
            "criterions": [
                {
                    "exact_snippets": "systemic diseases that have not been controlled stably",
                    "criterion": "systemic diseases",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not controlled stably"
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not controlled stably"
                        }
                    ]
                },
                {
                    "exact_snippets": "liver cirrhosis (Child Pugh Class B or C)",
                    "criterion": "liver cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "Child Pugh Class",
                            "expected_value": [
                                "B",
                                "C"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not controlled stably"
                        }
                    ]
                },
                {
                    "exact_snippets": "obstructive pulmonary disease",
                    "criterion": "obstructive pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "not controlled stably"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant cardiovascular disease patients(According to the specific requirements of the plan);",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with active autoimmune diseases or immunodeficiency, or a history of the aforementioned conditions, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc., shall not be included. The following exceptions apply: Patients with a history of autoimmune hypothyroidism who have received thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar can be controlled after treatment with insulin administration scheme can participate in this study;",
            "criterions": [
                {
                    "exact_snippets": "active autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of the aforementioned conditions",
                    "criterion": "history of autoimmune diseases or immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune hepatitis",
                    "criterion": "autoimmune hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uveitis",
                    "criterion": "uveitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pituitary inflammation",
                    "criterion": "pituitary inflammation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vasculitis",
                    "criterion": "vasculitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "nephritis",
                    "criterion": "nephritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune hypothyroidism ... thyroid hormone replacement therapy",
                    "criterion": "autoimmune hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "thyroid hormone replacement therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "type 1 diabetes ... blood sugar can be controlled ... insulin administration scheme",
                    "criterion": "type 1 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "insulin administration scheme"
                        },
                        {
                            "requirement_type": "blood sugar control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a history of other malignant tumors within five years (excluding complete treatment for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma skin cancer);",
            "criterions": [
                {
                    "exact_snippets": "history of other malignant tumors within five years",
                    "criterion": "history of other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "complete treatment for in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "complete treatment for ... basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "complete"
                        }
                    ]
                },
                {
                    "exact_snippets": "complete treatment for ... squamous cell carcinoma skin cancer",
                    "criterion": "squamous cell carcinoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "complete"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 2000 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;",
            "criterions": [
                {
                    "exact_snippets": "congenital or acquired immune deficiency",
                    "criterion": "immune deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B (HBV DNA ≥ 2000 IU / ml)",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "IU/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "HCV antibody",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "HCV-RNA level",
                            "expected_value": "higher than the detection limit of the analytical method"
                        }
                    ]
                },
                {
                    "exact_snippets": "co infection of hepatitis B and hepatitis C",
                    "criterion": "co-infection of hepatitis B and hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (>38.5%) of unknown reason occurred during the screening period/before the first administration；",
            "criterions": [
                {
                    "exact_snippets": "Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration",
                    "criterion": "severe infection",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 4 weeks before the first administration"
                        }
                    ]
                },
                {
                    "exact_snippets": "fever (>38.5%) of unknown reason occurred during the screening period/before the first administration",
                    "criterion": "fever of unknown reason",
                    "requirements": [
                        {
                            "requirement_type": "temperature",
                            "expected_value": {
                                "operator": ">",
                                "value": 38.5,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "during the screening period/before the first administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently participating in intervention clinical research treatment, or receiving other investigational drugs or research instruments within 4 weeks prior to the first administration; Not fully recovered from toxicity and/or complications caused by any intervention measures prior to initial administration (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss);",
            "criterions": [
                {
                    "exact_snippets": "Currently participating in intervention clinical research treatment",
                    "criterion": "participation in intervention clinical research treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving other investigational drugs or research instruments within 4 weeks prior to the first administration",
                    "criterion": "receipt of investigational drugs or research instruments",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Not fully recovered from toxicity and/or complications caused by any intervention measures prior to initial administration (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss)",
                    "criterion": "recovery from toxicity and/or complications",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "level"
                            }
                        },
                        {
                            "requirement_type": "recovery status",
                            "expected_value": "reaching baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a clear history of allergies and may have potential allergies or intolerance to the investigational drug and its similar biological agents;",
            "criterions": [
                {
                    "exact_snippets": "clear history of allergies",
                    "criterion": "history of allergies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "potential allergies or intolerance to the investigational drug and its similar biological agents",
                    "criterion": "potential allergies or intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;",
            "criterions": [
                {
                    "exact_snippets": "history of abuse of psychotropic substances",
                    "criterion": "abuse of psychotropic substances",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to quit",
                    "criterion": "ability to quit psychotropic substances",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}