{
    "info": {
        "nct_id": "NCT05751265",
        "official_title": "Tislelizumab Combined With Chemotherapy in the Cross-line Treatment of First-line Resistant Advanced Gastric Cancer, Single-arm, Exploratory Clinical Study",
        "inclusion_criteria": "* Gastric adenocarcinoma confirmed by pathology (including histology or cytology) and locally advanced or metastatic (stage IV) tumor that is unresectable; There is no known HER2+.\n* Age 18-75;\n* ECOG score: 0-2;\n* Patients who had previously failed first-line immunization combined with chemotherapy (oxaliplatin combined with capecitabine or FP);\n* Adequate organ and bone marrow function, meeting the following definitions:\n\n  1. Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L;\n  2. Blood biochemistry Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;\n* Expected survival > 6 months;\n* Fertile female subjects and male subjects whose partners are of childbearing age are required to use a medically approved contraceptive during the study treatment period and for at least 3 months after the last treatment;\n* Patients who volunteered to participate in this study and signed informed consent.\n* According to RECIST1.1 criteria, the patient had at least one target lesion with a measurable diameter (tumor lesion with long diameter ≥10mm, lymph node lesion with short diameter ≥15mm, scanning layer thickness 5mm);\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients who received first-line immunotherapy for less than 3 months or experienced hyperprogression in first-line therapy or developed Grade 3 or above irAE during first-line therapy;\n* Patients who have previously received other immunotherapy (including other investigational drugs) with less than 5 half-lives since the initial investigational drug use.\n* Pregnant or lactating women;\n* Participants who participated in other clinical studies and did not recover toxic reactions 28 days before enrollment;\n* Have had other malignancies in the last 5 years or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;\n* Severe heart, liver, lung and kidney diseases; Neurological and mental diseases;\n* The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may be characterized by the presence of clinical symptoms, cerebral edema, spinal cord compression meningitis, pia meningeal disease, and/or progressive growth.For patients with CNS metastases that are adequately treated and whose neurological symptoms return to baseline at least 2 weeks prior to randomization (residual signs or symptoms associated with CNS treatment can be enrolled.In addition, subjects must either stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 2 weeks prior to randomization;\n* Patients with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) who cannot be reduced to the normal range after antihypertensive medication;\n* Patients with grade I or above coronary heart disease, arrhythmias (including prolonged QTc interval > 450 ms in men and > 470 ms in women), and cardiac insufficiency;\n* Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN);\n* Patients with a history of cardiovascular and cerebrovascular diseases who are still taking thrombolytic drugs or anticoagulants orally.\n* Presence of any active, known or suspected autoimmune disease.Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted: e.g., type 1 diabetes, hypothyroidism requiring hormone replacement therapy only, and skin conditions requiring no systemic therapy (e.g., vitiligo, psoriasis, and alopecia).\n* Concurrent autoimmune diseases or a history of chronic or recurrent immune diseases, including a history of immunodeficiency such as HIV-positive testing or a history of organ transplantation and allogeneic bone marrow transplantation.\n* Patients with other concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study;\n* Patients with uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity is judged by the investigator to be likely to prevent the signing of informed consent or have multiple factors affecting oral medication (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea, and intestinal obstruction);\n* Allergic to the test drug or its excipients;\n* Persons deemed unsuitable for inclusion by the researcher.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Gastric adenocarcinoma confirmed by pathology (including histology or cytology) and locally advanced or metastatic (stage IV) tumor that is unresectable; There is no known HER2+.",
            "criterions": [
                {
                    "exact_snippets": "Gastric adenocarcinoma confirmed by pathology (including histology or cytology)",
                    "criterion": "gastric adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "pathology",
                                "histology",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic (stage IV) tumor that is unresectable",
                    "criterion": "tumor stage and resectability",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced or metastatic (stage IV)"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "There is no known HER2+",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "not HER2+"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18-75;",
            "criterions": [
                {
                    "exact_snippets": "Age 18-75",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG score: 0-2;",
            "criterions": [
                {
                    "exact_snippets": "ECOG score: 0-2",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who had previously failed first-line immunization combined with chemotherapy (oxaliplatin combined with capecitabine or FP);",
            "criterions": [
                {
                    "exact_snippets": "previously failed first-line immunization combined with chemotherapy (oxaliplatin combined with capecitabine or FP)",
                    "criterion": "previous failure of first-line immunization combined with chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oxaliplatin combined with capecitabine",
                                "FP"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and bone marrow function, meeting the following definitions:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L;",
            "criterions": [
                {
                    "exact_snippets": "Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment)",
                    "criterion": "blood routine",
                    "requirements": [
                        {
                            "requirement_type": "blood transfusion",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "granulocyte colony stimulating factor [G-CSF]",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "other drug correction",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days before treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute count of neutrophils (ANC) ≥1.5×109/L",
                    "criterion": "absolute count of neutrophils (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin (HB) ≥9.0 g/dL",
                    "criterion": "hemoglobin (HB)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count (PLT) ≥80×109/L",
                    "criterion": "platelet count (PLT)",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Blood biochemistry Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance ≥60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum albumin ≥2.8g/dL",
                    "criterion": "serum albumin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin (TBIL) ≤ 1.5×ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN",
                    "criterion": "aspartate aminotransferase or alanine aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival > 6 months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival > 6 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile female subjects and male subjects whose partners are of childbearing age are required to use a medically approved contraceptive during the study treatment period and for at least 3 months after the last treatment;",
            "criterions": [
                {
                    "exact_snippets": "Fertile female subjects",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male subjects whose partners are of childbearing age",
                    "criterion": "partner's childbearing age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use a medically approved contraceptive during the study treatment period and for at least 3 months after the last treatment",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study treatment period and for at least 3 months after the last treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who volunteered to participate in this study and signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "volunteered to participate",
                    "criterion": "volunteering",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* According to RECIST1.1 criteria, the patient had at least one target lesion with a measurable diameter (tumor lesion with long diameter ≥10mm, lymph node lesion with short diameter ≥15mm, scanning layer thickness 5mm);",
            "criterions": [
                {
                    "exact_snippets": "at least one target lesion with a measurable diameter",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor lesion with long diameter ≥10mm",
                    "criterion": "tumor lesion",
                    "requirements": [
                        {
                            "requirement_type": "long diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph node lesion with short diameter ≥15mm",
                    "criterion": "lymph node lesion",
                    "requirements": [
                        {
                            "requirement_type": "short diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "scanning layer thickness 5mm",
                    "criterion": "scanning layer thickness",
                    "requirements": [
                        {
                            "requirement_type": "thickness",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who received first-line immunotherapy for less than 3 months or experienced hyperprogression in first-line therapy or developed Grade 3 or above irAE during first-line therapy;",
            "criterions": [
                {
                    "exact_snippets": "received first-line immunotherapy for less than 3 months",
                    "criterion": "duration of first-line immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "experienced hyperprogression in first-line therapy",
                    "criterion": "hyperprogression in first-line therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "developed Grade 3 or above irAE during first-line therapy",
                    "criterion": "irAE during first-line therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have previously received other immunotherapy (including other investigational drugs) with less than 5 half-lives since the initial investigational drug use.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received other immunotherapy (including other investigational drugs)",
                    "criterion": "previous immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 5 half-lives since the initial investigational drug use",
                    "criterion": "time since initial investigational drug use",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who participated in other clinical studies and did not recover toxic reactions 28 days before enrollment;",
            "criterions": [
                {
                    "exact_snippets": "Participants who participated in other clinical studies",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "did not recover toxic reactions 28 days before enrollment",
                    "criterion": "recovery from toxic reactions",
                    "requirements": [
                        {
                            "requirement_type": "time since recovery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have had other malignancies in the last 5 years or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;",
            "criterions": [
                {
                    "exact_snippets": "Have had other malignancies in the last 5 years",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancies ... at the same time",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "concurrent presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for cured basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe heart, liver, lung and kidney diseases; Neurological and mental diseases;",
            "criterions": [
                {
                    "exact_snippets": "Severe heart ... diseases",
                    "criterion": "heart diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe ... liver ... diseases",
                    "criterion": "liver diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe ... lung ... diseases",
                    "criterion": "lung diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe ... kidney diseases",
                    "criterion": "kidney diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Neurological ... diseases",
                    "criterion": "neurological diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental diseases",
                    "criterion": "mental diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may be characterized by the presence of clinical symptoms, cerebral edema, spinal cord compression meningitis, pia meningeal disease, and/or progressive growth.For patients with CNS metastases that are adequately treated and whose neurological symptoms return to baseline at least 2 weeks prior to randomization (residual signs or symptoms associated with CNS treatment can be enrolled.In addition, subjects must either stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 2 weeks prior to randomization;",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled or symptomatic active central nervous system (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms",
                    "criterion": "clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebral edema",
                    "criterion": "cerebral edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meningitis",
                    "criterion": "meningitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pia meningeal disease",
                    "criterion": "pia meningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive growth",
                    "criterion": "progressive growth",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological symptoms return to baseline at least 2 weeks prior to randomization",
                    "criterion": "neurological symptoms",
                    "requirements": [
                        {
                            "requirement_type": "baseline return",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 2 weeks prior to randomization",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "cessation or reduction",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) who cannot be reduced to the normal range after antihypertensive medication;",
            "criterions": [
                {
                    "exact_snippets": "hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure >140 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure >90 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be reduced to the normal range after antihypertensive medication",
                    "criterion": "blood pressure control with medication",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN);",
            "criterions": [
                {
                    "exact_snippets": "abnormal coagulation function (INR>1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal coagulation function ... APTT>1.5 ULN",
                    "criterion": "APTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of cardiovascular and cerebrovascular diseases who are still taking thrombolytic drugs or anticoagulants orally.",
            "criterions": [
                {
                    "exact_snippets": "history of cardiovascular and cerebrovascular diseases",
                    "criterion": "cardiovascular and cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taking thrombolytic drugs",
                    "criterion": "thrombolytic drugs",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "taking ... anticoagulants orally",
                    "criterion": "oral anticoagulants",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of any active, known or suspected autoimmune disease.Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted: e.g., type 1 diabetes, hypothyroidism requiring hormone replacement therapy only, and skin conditions requiring no systemic therapy (e.g., vitiligo, psoriasis, and alopecia).",
            "criterions": [
                {
                    "exact_snippets": "Presence of any active, known or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects who are in a stable state and do not require systemic immunosuppressive therapy",
                    "criterion": "systemic immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "type 1 diabetes",
                    "criterion": "type 1 diabetes",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypothyroidism requiring hormone replacement therapy only",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement therapy only"
                        }
                    ]
                },
                {
                    "exact_snippets": "skin conditions requiring no systemic therapy (e.g., vitiligo, psoriasis, and alopecia)",
                    "criterion": "skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "no systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent autoimmune diseases or a history of chronic or recurrent immune diseases, including a history of immunodeficiency such as HIV-positive testing or a history of organ transplantation and allogeneic bone marrow transplantation.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of chronic or recurrent immune diseases",
                    "criterion": "chronic or recurrent immune diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of immunodeficiency such as HIV-positive testing",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... allogeneic bone marrow transplantation",
                    "criterion": "allogeneic bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with other concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study;",
            "criterions": [
                {
                    "exact_snippets": "other concomitant diseases",
                    "criterion": "concomitant diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "seriously endanger the patient's safety or affect the patient's completion of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity is judged by the investigator to be likely to prevent the signing of informed consent or have multiple factors affecting oral medication (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea, and intestinal obstruction);",
            "criterions": [
                {
                    "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
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorder whose clinical severity is judged by the investigator to be likely to prevent the signing of informed consent",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "likely to prevent signing of informed consent"
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple factors affecting oral medication (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea, and intestinal obstruction)",
                    "criterion": "factors affecting oral medication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "inability to swallow",
                                "persistent uncontrollable nausea and vomiting",
                                "chronic diarrhea",
                                "intestinal obstruction"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergic to the test drug or its excipients;",
            "criterions": [
                {
                    "exact_snippets": "Allergic to the test drug",
                    "criterion": "allergy to test drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Allergic to ... its excipients",
                    "criterion": "allergy to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persons deemed unsuitable for inclusion by the researcher.",
            "criterions": [
                {
                    "exact_snippets": "Persons deemed unsuitable for inclusion by the researcher.",
                    "criterion": "suitability for inclusion",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "suitable"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients with grade I or above coronary heart disease, arrhythmias (including prolonged QTc interval > 450 ms in men and > 470 ms in women), and cardiac insufficiency;",
            "criterions": [
                {
                    "exact_snippets": "grade I or above coronary heart disease",
                    "criterion": "coronary heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prolonged QTc interval > 450 ms in men",
                    "criterion": "QTc interval in men",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "prolonged QTc interval > 470 ms in women",
                    "criterion": "QTc interval in women",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac insufficiency",
                    "criterion": "cardiac insufficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}