{
    "info": {
        "nct_id": "NCT06519591",
        "official_title": "Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis",
        "inclusion_criteria": "1. Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;\n2. Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;\n3. Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);\n4. Age ≥ 18 years at registration;\n5. Eastern Cooperative Oncology Group (ECOG) score ≤ 1;\n6. Expected life expectancy > 3 months;\n7. Adequate bone marrow, liver, and renal functions.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);\n2. During pregnancy, within 28 days of post parturition, or during lactation;\n3. Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.\n4. Synchronous or metachronous (within 5 years) malignancies.\n5. Severe mental disease, uncontrolled epilepsy, or central nervous system disease;\n6. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;\n7. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;\n8. Known peripheral neuropathy (> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;\n9. Patients on steroid or immunosuppressant treatment after organ transplant;\n10. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;\n11. Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine > upper limit of normal (ULN), 115 μmol/L;\n12. Known dihydropyrimidine dehydrogenase (DPD) deficiency;\n13. Anaphylaxis to paclitaxel or any research drug ingredient.\n14. Active autoimmune disease or history of refractory autoimmune disease;\n15. Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;\n16. HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);\n17. Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;\n18. Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed gastric adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed gastric adenocarcinoma",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "her 2 (-)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "without the history of resection of primary or metastatic lesion",
                    "criterion": "history of resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction; Written (signed) informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Peritoneal metastases from gastric cancer",
                    "criterion": "peritoneal metastases",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": "gastric cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring definitive diagnosis by laparoscopy",
                    "criterion": "definitive diagnosis by laparoscopy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "without gastric outflow tract obstruction",
                    "criterion": "gastric outflow tract obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "without ... intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Written (signed) informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "written and signed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Claudin 18.2 positive (≥ 25%, and the proportion of positive cells greater than 50% of the cases accounted for not less than 70%);",
            "criterions": [
                {
                    "exact_snippets": "Claudin 18.2 positive (≥ 25% ... proportion of positive cells greater than 50% ... accounted for not less than 70%)",
                    "criterion": "Claudin 18.2 expression",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "proportion of positive cells",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "cases accounted for",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age ≥ 18 years at registration;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) score ≤ 1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) score ≤ 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Expected life expectancy > 3 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Adequate bone marrow, liver, and renal functions.",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... liver",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... renal functions",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);",
            "criterions": [
                {
                    "exact_snippets": "Confirmed of evidence of distant metastasis other than peritoneal metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peritoneal metastasis",
                    "criterion": "peritoneal metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "liver metastasis",
                    "criterion": "liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lung metastasis",
                    "criterion": "lung metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "para-aortic lymph node metastasis",
                    "criterion": "para-aortic lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. During pregnancy, within 28 days of post parturition, or during lactation;",
            "criterions": [
                {
                    "exact_snippets": "During pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days of post parturition",
                    "criterion": "post parturition",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "during lactation",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4 or targeted therapy such as Claudin 18.2.",
            "criterions": [
                {
                    "exact_snippets": "Previously received immunotherapy such as PD-1/PD-L1 and CTLA-4",
                    "criterion": "previous immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously received ... targeted therapy such as Claudin 18.2",
                    "criterion": "previous targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Synchronous or metachronous (within 5 years) malignancies.",
            "criterions": [
                {
                    "exact_snippets": "Synchronous or metachronous (within 5 years) malignancies",
                    "criterion": "malignancies",
                    "requirements": [
                        {
                            "requirement_type": "synchronous or metachronous",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Severe mental disease, uncontrolled epilepsy, or central nervous system disease;",
            "criterions": [
                {
                    "exact_snippets": "Severe mental disease",
                    "criterion": "mental disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "central nervous system disease",
                    "criterion": "central nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;",
            "criterions": [
                {
                    "exact_snippets": "Clinically severe (i.e. active) heart disease",
                    "criterion": "clinically severe heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic coronary heart disease",
                    "criterion": "symptomatic coronary heart disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association (NYHA) class II or more severe congestive heart failure",
                    "criterion": "NYHA class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmia requiring drug intervention",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "drug intervention"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of myocardial infarction in the last 12 months",
                    "criterion": "history of myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;",
            "criterions": [
                {
                    "exact_snippets": "Upper gastrointestinal obstruction",
                    "criterion": "upper gastrointestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal physiological function",
                    "criterion": "abnormal physiological function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Known peripheral neuropathy (> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;",
            "criterions": [
                {
                    "exact_snippets": "Known peripheral neuropathy (> NCI-CTC AE 1)",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI-CTC AE"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "disappearance of deep tendon reflex (DTR)",
                    "criterion": "deep tendon reflex",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients on steroid or immunosuppressant treatment after organ transplant;",
            "criterions": [
                {
                    "exact_snippets": "Patients on steroid ... treatment",
                    "criterion": "steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients on ... immunosuppressant treatment",
                    "criterion": "immunosuppressant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;",
            "criterions": [
                {
                    "exact_snippets": "severe uncontrolled recurrent infections",
                    "criterion": "recurrent infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other severe uncontrolled concomitant disease",
                    "criterion": "concomitant disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine > upper limit of normal (ULN), 115 μmol/L;",
            "criterions": [
                {
                    "exact_snippets": "Moderate or severe renal damage",
                    "criterion": "renal damage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≤ 50 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine > upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "> ULN"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine ... 115 μmol/L",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 115,
                                "unit": "μmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Known dihydropyrimidine dehydrogenase (DPD) deficiency;",
            "criterions": [
                {
                    "exact_snippets": "Known dihydropyrimidine dehydrogenase (DPD) deficiency",
                    "criterion": "dihydropyrimidine dehydrogenase (DPD) deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Anaphylaxis to paclitaxel or any research drug ingredient.",
            "criterions": [
                {
                    "exact_snippets": "Anaphylaxis to paclitaxel",
                    "criterion": "anaphylaxis to paclitaxel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Anaphylaxis to ... any research drug ingredient",
                    "criterion": "anaphylaxis to any research drug ingredient",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Active autoimmune disease or history of refractory autoimmune disease;",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of refractory autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "refractory"
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;",
            "criterions": [
                {
                    "exact_snippets": "hypothyroidism requiring only hormone replacement therapy",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia)",
                    "criterion": "skin diseases",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "without systemic treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;",
            "criterions": [
                {
                    "exact_snippets": "Steroid or other systemic immunosuppressive therapy was used 14 days before admission",
                    "criterion": "use of steroid or systemic immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "14 days before admission"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose)",
                    "criterion": "dose of systemic glucocorticoids",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "by nasal spray, inhalation or other routes",
                    "criterion": "route of administration",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "nasal spray",
                                "inhalation",
                                "other routes"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "hormones used to prevent allergy of contrast agents",
                    "criterion": "use of hormones",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "prevent allergy of contrast agents"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 12 months before admission",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "16. HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);",
            "criterions": [
                {
                    "exact_snippets": "HIV antibody positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "antibody presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "hepatitis B status",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B: HBsAg positive",
                    "criterion": "hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B: ... HBV DNA ≥10 copies/ml",
                    "criterion": "HBV DNA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "copies/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "hepatitis C status",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C: HCV antibody ... positive",
                    "criterion": "HCV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C: ... HCV-RNA positive",
                    "criterion": "HCV-RNA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring antiviral treatment at the same time",
                    "criterion": "antiviral treatment requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}