{
    "info": {
        "nct_id": "NCT06078982",
        "official_title": "Efficacy and Safety of Disitamab Vedotin Combined With PD-1 in Posterior Line Therapy of Advanced HER2-low Expressing Gastric Cancer",
        "inclusion_criteria": "1. Must voluntarily join this study and sign an informed consent form;\n2. Age 18-70 years old (including 18 years old and 70 years old);\n3. Expected survival period ≥ 12 weeks;\n4. ECOG physical fitness score 0 or 1 point;\n5. Patients with incurable and unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) confirmed by histology or cytology;\n6. The HER2 immunohistochemistry (IHC) test results are IHC 1+, the subject's previous test results (confirmed by the investigator) or the test results of the research center are acceptable;\n7. The patient has received second-line treatment (at least) after tumor recurrence/metastasis\n8. Evidence of tumor disease progression during or after the most recent treatment, as documented by medical history or confirmed by the investigator;\n9. At least one measurable lesion according to RECIST 1.1;\n10. For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptives) during the study treatment period and within 6 months after the end of the study treatment period. pills or condoms), must have a negative blood pregnancy test within 7 days prior to study enrollment, and must be non-lactating; for male subjects: should for surgical sterilization, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period of the experimental group subjects;\n11. Sufficient organ function:\n\n    1. Bone marrow function: hemoglobin ≥ 9g/dL; absolute neutrophil count ≥ 1.5×109/L; platelet ≥ 100×109/L;\n    2. Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); when there is no liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST and alkaline phosphatase (ALP) ≤ 2.5×ULN, and in the presence of liver metastases ALT, AST, and ALP are ≤ 5×ULN;\n    3. Renal function (subject to the normal value of the clinical trial center): blood creatinine ≤ 1.5×ULN, or creatinine clearance rate (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula method, or 24-hour urine CrCl ≥ 60 mL/min;\n    4. Heart function: New York Heart Association (NYHA) classification < Grade 3; left ventricular ejection fraction ≥ 50%;\n12. Able to understand trial requirements, willing and able to comply with trial and follow-up procedures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. Brain metastasis or leptomeningeal metastasis;\n2. Tumor lesions with a bleeding tendency (e.g., active ulcerated tumor lesions with a positive fecal occult blood test, history of vomiting blood or black stools within 2 months prior to signing the informed consent, risk of gastrointestinal hemorrhage in the judgment of the investigator) or previous blood transfusions in the 4 weeks prior to study drug administration;\n3. Suffering from other malignant tumors within 5 years before signing the informed consent form (non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or other tumors that have been effectively treated, except for malignant tumors that are considered cured);\n4. Received chemotherapy, radiotherapy, and immune therapy within 4 weeks before the start of the study drug\n5. Received palliative radiotherapy for bone metastases within 2 weeks before the start of the study drug;\n6. Received anti-tumor traditional Chinese medicine treatment within 2 weeks before the start of the study drug;\n7. The toxicity caused by previous anti-tumor therapy has not recovered to CTCAE (version 4.03) grade 0-1 (except for alopecia, hyperpigmentation, and long-term toxicity caused by radiotherapy, which in the judgment of the investigator cannot be recovered);\n8. Prior treatment with T-DM1 or participation in a clinical study of this type of drug;\n9. The study drug has been used within 4 weeks before the start of the study drug;\n10. Major surgery has been performed within 4 weeks before the start of the study drug and the patient has not fully recovered;\n11. Have been vaccinated with live vaccines within 4 weeks before the start of the study drug or plan to receive any vaccines during the study period;\n12. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, pulmonary embolism, and myocardial infarction, occurred within 1 year before the study drug;\n13. Suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, liver cirrhosis, angina pectoris, serious arrhythmia, etc.;\n14. Suffering from active infection requiring systemic treatment;\n15. History of active tuberculosis;\n16. Positive human immunodeficiency virus (HIV) test result;\n17. Patients with active hepatitis B or C (HBsAg positive and HBV DNA titers higher than the upper limit of normal when HBsAg is positive; HCVAb positive and HCV RNA titers higher than the upper limit of normal when HBsAg is positive);\n18. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (including massive pleural effusion or ascites);\n19. Known to have hypersensitivity or delayed allergic reactions to certain components of RC48-ADC or similar drugs;\n20. Exclude, at the investigator's discretion, other conditions that might confuse the study results or affect the subjects' ability to follow the study procedures, such as alcoholism, drug abuse, mental disorders, criminal detention, etc.;\n21. Suffering from any other disease, metabolic abnormality, abnormal physical examination, or abnormal laboratory test, according to the judgment of the investigator, there is reason to suspect that the subject has a certain disease or condition that is not suitable for the use of the study drug, or will affect the research results interpretations, or situations that place the subject at high risk;\n22. Women who are pregnant or breastfeeding or women/men who are planning to give birth;\n23. It is estimated that the subjects' compliance to participate in this clinical study is insufficient or the investigators believe that there are other factors that are not suitable for participating in this study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Must voluntarily join this study and sign an informed consent form;",
            "criterions": [
                {
                    "exact_snippets": "Must voluntarily join this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign an informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Age 18-70 years old (including 18 years old and 70 years old);",
            "criterions": [
                {
                    "exact_snippets": "Age 18-70 years old (including 18 years old and 70 years old)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Expected survival period ≥ 12 weeks;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival period ≥ 12 weeks",
                    "criterion": "expected survival period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ECOG physical fitness score 0 or 1 point;",
            "criterions": [
                {
                    "exact_snippets": "ECOG physical fitness score 0 or 1 point",
                    "criterion": "ECOG physical fitness score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients with incurable and unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) confirmed by histology or cytology;",
            "criterions": [
                {
                    "exact_snippets": "incurable and unresectable locally advanced or metastatic gastric cancer",
                    "criterion": "gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": "incurable"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": "unresectable"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "gastroesophageal junction adenocarcinoma",
                    "criterion": "gastroesophageal junction adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histology or cytology",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The HER2 immunohistochemistry (IHC) test results are IHC 1+, the subject's previous test results (confirmed by the investigator) or the test results of the research center are acceptable;",
            "criterions": [
                {
                    "exact_snippets": "HER2 immunohistochemistry (IHC) test results are IHC 1+",
                    "criterion": "HER2 IHC test result",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "IHC 1+"
                        }
                    ]
                },
                {
                    "exact_snippets": "subject's previous test results (confirmed by the investigator) ... are acceptable",
                    "criterion": "previous test results",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "confirmed by the investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "test results of the research center are acceptable",
                    "criterion": "research center test results",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The patient has received second-line treatment (at least) after tumor recurrence/metastasis",
            "criterions": [
                {
                    "exact_snippets": "The patient has received second-line treatment (at least)",
                    "criterion": "second-line treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Evidence of tumor disease progression during or after the most recent treatment, as documented by medical history or confirmed by the investigator;",
            "criterions": [
                {
                    "exact_snippets": "Evidence of tumor disease progression",
                    "criterion": "tumor disease progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented by medical history",
                    "criterion": "documentation of tumor disease progression",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "medical history"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by the investigator",
                    "criterion": "confirmation of tumor disease progression",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "investigator confirmation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. At least one measurable lesion according to RECIST 1.1;",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion according to RECIST 1.1",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptives) during the study treatment period and within 6 months after the end of the study treatment period. pills or condoms), must have a negative blood pregnancy test within 7 days prior to study enrollment, and must be non-lactating; for male subjects: should for surgical sterilization, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period of the experimental group subjects;",
            "criterions": [
                {
                    "exact_snippets": "female subjects: should be surgically sterilized",
                    "criterion": "female surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects: ... postmenopausal patients",
                    "criterion": "female postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects: ... agree to use at least one medically approved contraceptive measure",
                    "criterion": "female contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects: ... must have a negative blood pregnancy test within 7 days prior to study enrollment",
                    "criterion": "female blood pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "female subjects: ... must be non-lactating",
                    "criterion": "female lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects: should for surgical sterilization",
                    "criterion": "male surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects: ... agree to use a medically approved contraceptive method",
                    "criterion": "male contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Sufficient organ function:",
            "criterions": [
                {
                    "exact_snippets": "Sufficient organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Bone marrow function: hemoglobin ≥ 9g/dL; absolute neutrophil count ≥ 1.5×109/L; platelet ≥ 100×109/L;",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow function: hemoglobin ≥ 9g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone marrow function: ... absolute neutrophil count ≥ 1.5×109/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone marrow function: ... platelet ≥ 100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); when there is no liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST and alkaline phosphatase (ALP) ≤ 2.5×ULN, and in the presence of liver metastases ALT, AST, and ALP are ≤ 5×ULN;",
            "criterions": [
                {
                    "exact_snippets": "serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN)",
                    "criterion": "serum total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "when there is no liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST and alkaline phosphatase (ALP) ≤ 2.5×ULN",
                    "criterion": "alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in the presence of liver metastases ALT, AST, and ALP are ≤ 5×ULN",
                    "criterion": "alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Renal function (subject to the normal value of the clinical trial center): blood creatinine ≤ 1.5×ULN, or creatinine clearance rate (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula method, or 24-hour urine CrCl ≥ 60 mL/min;",
            "criterions": [
                {
                    "exact_snippets": "Renal function (subject to the normal value of the clinical trial center)",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "normal value",
                            "expected_value": "subject to the normal value of the clinical trial center"
                        }
                    ]
                },
                {
                    "exact_snippets": "blood creatinine ≤ 1.5×ULN",
                    "criterion": "blood creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance rate (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula method",
                    "criterion": "creatinine clearance rate (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "24-hour urine CrCl ≥ 60 mL/min",
                    "criterion": "24-hour urine CrCl",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Heart function: New York Heart Association (NYHA) classification < Grade 3; left ventricular ejection fraction ≥ 50%;",
            "criterions": [
                {
                    "exact_snippets": "Heart function: New York Heart Association (NYHA) classification < Grade 3",
                    "criterion": "NYHA classification",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction ≥ 50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Able to understand trial requirements, willing and able to comply with trial and follow-up procedures.",
            "criterions": [
                {
                    "exact_snippets": "Able to understand trial requirements",
                    "criterion": "understanding of trial requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing and able to comply with trial and follow-up procedures",
                    "criterion": "compliance with trial and follow-up procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must 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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Brain metastasis or leptomeningeal metastasis;",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "leptomeningeal metastasis",
                    "criterion": "leptomeningeal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Tumor lesions with a bleeding tendency (e.g., active ulcerated tumor lesions with a positive fecal occult blood test, history of vomiting blood or black stools within 2 months prior to signing the informed consent, risk of gastrointestinal hemorrhage in the judgment of the investigator) or previous blood transfusions in the 4 weeks prior to study drug administration;",
            "criterions": [
                {
                    "exact_snippets": "Tumor lesions with a bleeding tendency",
                    "criterion": "tumor lesions",
                    "requirements": [
                        {
                            "requirement_type": "bleeding tendency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active ulcerated tumor lesions with a positive fecal occult blood test",
                    "criterion": "ulcerated tumor lesions",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "fecal occult blood test",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of vomiting blood or black stools within 2 months prior to signing the informed consent",
                    "criterion": "vomiting blood or black stools",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 months prior to signing the informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "risk of gastrointestinal hemorrhage in the judgment of the investigator",
                    "criterion": "gastrointestinal hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "judgment of the investigator",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous blood transfusions in the 4 weeks prior to study drug administration",
                    "criterion": "blood transfusions",
                    "requirements": [
                        {
                            "requirement_type": "previous",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "in the 4 weeks prior to study drug administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Suffering from other malignant tumors within 5 years before signing the informed consent form (non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or other tumors that have been effectively treated, except for malignant tumors that are considered cured);",
            "criterions": [
                {
                    "exact_snippets": "Suffering from other malignant tumors within 5 years before signing the informed consent form",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or other tumors that have been effectively treated",
                    "criterion": "specific tumor types",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "cervical carcinoma in situ",
                                "ductal carcinoma in situ",
                                "other tumors that have been effectively treated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "malignant tumors that are considered cured",
                    "criterion": "malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "considered cured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Received chemotherapy, radiotherapy, and immune therapy within 4 weeks before the start of the study drug",
            "criterions": [
                {
                    "exact_snippets": "Received chemotherapy ... within 4 weeks before the start of the study drug",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... radiotherapy ... within 4 weeks before the start of the study drug",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... immune therapy within 4 weeks before the start of the study drug",
                    "criterion": "immune therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Received palliative radiotherapy for bone metastases within 2 weeks before the start of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Received palliative radiotherapy for bone metastases",
                    "criterion": "palliative radiotherapy for bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks before the start of the study drug"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Received anti-tumor traditional Chinese medicine treatment within 2 weeks before the start of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Received anti-tumor traditional Chinese medicine treatment within 2 weeks before the start of the study drug",
                    "criterion": "anti-tumor traditional Chinese medicine treatment",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The toxicity caused by previous anti-tumor therapy has not recovered to CTCAE (version 4.03) grade 0-1 (except for alopecia, hyperpigmentation, and long-term toxicity caused by radiotherapy, which in the judgment of the investigator cannot be recovered);",
            "criterions": [
                {
                    "exact_snippets": "toxicity caused by previous anti-tumor therapy has not recovered to CTCAE (version 4.03) grade 0-1",
                    "criterion": "toxicity recovery",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "CTCAE grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hyperpigmentation",
                    "criterion": "hyperpigmentation",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "long-term toxicity caused by radiotherapy, which in the judgment of the investigator cannot be recovered",
                    "criterion": "long-term radiotherapy toxicity",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Prior treatment with T-DM1 or participation in a clinical study of this type of drug;",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with T-DM1",
                    "criterion": "prior treatment with T-DM1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "participation in a clinical study of this type of drug",
                    "criterion": "participation in a clinical study of T-DM1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The study drug has been used within 4 weeks before the start of the study drug;",
            "criterions": [
                {
                    "exact_snippets": "The study drug has been used within 4 weeks before the start of the study drug",
                    "criterion": "study drug usage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Major surgery has been performed within 4 weeks before the start of the study drug and the patient has not fully recovered;",
            "criterions": [
                {
                    "exact_snippets": "Major surgery has been performed within 4 weeks before the start of the study drug",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "the patient has not fully recovered",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Have been vaccinated with live vaccines within 4 weeks before the start of the study drug or plan to receive any vaccines during the study period;",
            "criterions": [
                {
                    "exact_snippets": "vaccinated with live vaccines within 4 weeks before the start of the study drug",
                    "criterion": "vaccination with live vaccines",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to receive any vaccines during the study period",
                    "criterion": "vaccination during study period",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, pulmonary embolism, and myocardial infarction, occurred within 1 year before the study drug;",
            "criterions": [
                {
                    "exact_snippets": "Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, pulmonary embolism, and myocardial infarction, occurred within 1 year before the study drug",
                    "criterion": "arterial/venous thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 1 year before the study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, liver cirrhosis, angina pectoris, serious arrhythmia, etc.;",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled systemic diseases, including diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... acute lung disease",
                    "criterion": "acute lung disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... liver cirrhosis",
                    "criterion": "liver cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled systemic diseases, including ... serious arrhythmia",
                    "criterion": "serious arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Suffering from active infection requiring systemic treatment;",
            "criterions": [
                {
                    "exact_snippets": "Suffering from active infection requiring systemic treatment",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": "systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. History of active tuberculosis;",
            "criterions": [
                {
                    "exact_snippets": "History of active tuberculosis",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Positive human immunodeficiency virus (HIV) test result;",
            "criterions": [
                {
                    "exact_snippets": "Positive human immunodeficiency virus (HIV) test result",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients with active hepatitis B or C (HBsAg positive and HBV DNA titers higher than the upper limit of normal when HBsAg is positive; HCVAb positive and HCV RNA titers higher than the upper limit of normal when HBsAg is positive);",
            "criterions": [
                {
                    "exact_snippets": "Patients with active hepatitis B ... HBsAg positive",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBsAg positive",
                    "criterion": "HBsAg",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV DNA titers higher than the upper limit of normal",
                    "criterion": "HBV DNA titers",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HCVAb positive",
                    "criterion": "HCVAb",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV RNA titers higher than the upper limit of normal",
                    "criterion": "HCV RNA titers",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (including massive pleural effusion or ascites);",
            "criterions": [
                {
                    "exact_snippets": "Presence of third interstitial fluid",
                    "criterion": "third interstitial fluid",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be controlled by drainage or other methods",
                    "criterion": "control of third interstitial fluid",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "massive pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "massive"
                        }
                    ]
                },
                {
                    "exact_snippets": "ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Known to have hypersensitivity or delayed allergic reactions to certain components of RC48-ADC or similar drugs;",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity or delayed allergic reactions to certain components of RC48-ADC or similar drugs",
                    "criterion": "hypersensitivity or delayed allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Exclude, at the investigator's discretion, other conditions that might confuse the study results or affect the subjects' ability to follow the study procedures, such as alcoholism, drug abuse, mental disorders, criminal detention, etc.;",
            "criterions": [
                {
                    "exact_snippets": "alcoholism",
                    "criterion": "alcoholism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "criminal detention",
                    "criterion": "criminal detention",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Suffering from any other disease, metabolic abnormality, abnormal physical examination, or abnormal laboratory test, according to the judgment of the investigator, there is reason to suspect that the subject has a certain disease or condition that is not suitable for the use of the study drug, or will affect the research results interpretations, or situations that place the subject at high risk;",
            "criterions": [
                {
                    "exact_snippets": "Suffering from any other disease",
                    "criterion": "other disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic abnormality",
                    "criterion": "metabolic abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal physical examination",
                    "criterion": "abnormal physical examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal laboratory test",
                    "criterion": "abnormal laboratory test",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Women who are pregnant or breastfeeding or women/men who are planning to give birth;",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women/men who are planning to give birth",
                    "criterion": "planning to give birth",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. It is estimated that the subjects' compliance to participate in this clinical study is insufficient or the investigators believe that there are other factors that are not suitable for participating in this study.",
            "criterions": [
                {
                    "exact_snippets": "subjects' compliance to participate in this clinical study is insufficient",
                    "criterion": "compliance to participate",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "investigators believe that there are other factors that are not suitable for participating in this study",
                    "criterion": "suitability for participation",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}