{
    "info": {
        "nct_id": "NCT06639672",
        "official_title": "Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+/HER2- Breast Cancer: A Phase II Study",
        "inclusion_criteria": "* 1. Histologically or cytologically confirmed HR+/HER2- breast cancer\n* 2. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）\n* 3. ECOG performance status of 0-1;\n* 4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;\n* 5. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L;\n* 6. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;\n* 7. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min calculated using the Cockcroft-Gault formula corrected for body surface area;\n* 8. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);\n* 9. No severe organic heart disease or arrhythmias;\n* 10. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;\n* 11. Voluntary signed informed consent by the study participant.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "* 1. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.\n* 2. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.\n* 3. Poorly controlled tumor-related pain.\n* 4. Patients participating in other clinical studies simultaneously.\n* 5. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* 6. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.\n* 7. Active pulmonary tuberculosis.\n* 8. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.\n* 9. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.\n* 10. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death , such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.\n* 11. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.\n* 12. Patients who have previously received allogeneic stem cell or solid organ transplants.\n* 13. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1. Histologically or cytologically confirmed HR+/HER2- breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "HR+",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）",
            "criterions": [
                {
                    "exact_snippets": "cT1c-2N1-2M0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT1c-2N1-2M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "cT3N0-2M0",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT3N0-2M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "AJCC 7th",
                    "criterion": "AJCC edition",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "7th"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3. ECOG performance status of 0-1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10^9/L); PLT ≥ 100,000/mcL (100 × 10^9/L) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function, defined as: ... ANC ≥ 1,500/mcL (1.5 × 10^9/L)",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate bone marrow function, defined as: ... PLT ≥ 100,000/mcL (100 × 10^9/L)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no blood transfusion within 3 weeks",
                    "criterion": "blood transfusion",
                    "requirements": [
                        {
                            "requirement_type": "time since last transfusion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no ... growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing",
                    "criterion": "growth factor therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g/L;",
            "criterions": [
                {
                    "exact_snippets": "TBIL ≤ 1.5× upper limit of normal (ULN)",
                    "criterion": "total bilirubin (TBIL)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If no liver metastases, AST and ALT ≤ 2.5× ULN",
                    "criterion": "AST and ALT levels without liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if liver metastases are present, AST or ALT ≤ 3.0× ULN",
                    "criterion": "AST or ALT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALP ≤ 1.5× ULN",
                    "criterion": "alkaline phosphatase (ALP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "if liver metastases ≤ 2× ULN",
                    "criterion": "alkaline phosphatase (ALP) with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum albumin ≥ 30g/L",
                    "criterion": "serum albumin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "g/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;",
            "criterions": [
                {
                    "exact_snippets": "Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN.",
                    "criterion": "coagulation function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "INR or PT, APTT ≤ 1.5× ULN"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 7. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL/min calculated using the Cockcroft-Gault formula corrected for body surface area;",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function, defined as creatinine ≤ 1.5× ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function, defined as ... Ccr ≥ 50 mL/min",
                    "criterion": "creatinine clearance (Ccr)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 8. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);",
            "criterions": [
                {
                    "exact_snippets": "Baseline left ventricular ejection fraction (LVEF) ≥ 50%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "baseline measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO)",
                    "criterion": "measurement method for LVEF",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "multiple-gated acquisition (MUGA)",
                                "echocardiogram (ECHO)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 9. No severe organic heart disease or arrhythmias;",
            "criterions": [
                {
                    "exact_snippets": "No severe organic heart disease",
                    "criterion": "organic heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 10. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (aged 15-49 years)",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 15,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 49,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative pregnancy test within 7 days before starting treatment",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days before starting treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment",
                    "criterion": "use of contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and for 3 months after discontinuation of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 11. Voluntary signed informed consent by the study participant.",
            "criterions": [
                {
                    "exact_snippets": "Voluntary signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "voluntary",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 1. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "history of mental illness",
                    "criterion": "mental illness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with mental disorders at the time of enrollment",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 2. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.",
            "criterions": [
                {
                    "exact_snippets": "communication barriers due to confusion",
                    "criterion": "communication barriers",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "confusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "communication barriers due to ... aphasia",
                    "criterion": "communication barriers",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "aphasia"
                        }
                    ]
                },
                {
                    "exact_snippets": "communication barriers due to ... intellectual disability",
                    "criterion": "communication barriers",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "intellectual disability"
                        }
                    ]
                },
                {
                    "exact_snippets": "communication barriers due to ... other reasons",
                    "criterion": "communication barriers",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "other reasons"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 3. Poorly controlled tumor-related pain.",
            "criterions": [
                {
                    "exact_snippets": "Poorly controlled tumor-related pain",
                    "criterion": "tumor-related pain",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 4. Patients participating in other clinical studies simultaneously.",
            "criterions": [
                {
                    "exact_snippets": "Patients participating in other clinical studies",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 5. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.",
            "criterions": [
                {
                    "exact_snippets": "active or past autoimmune diseases or immunodeficiencies",
                    "criterion": "autoimmune diseases or immunodeficiencies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myasthenia gravis",
                    "criterion": "myasthenia gravis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myositis",
                    "criterion": "myositis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune hepatitis",
                    "criterion": "autoimmune hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "antiphospholipid syndrome",
                    "criterion": "antiphospholipid syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Wegener's granulomatosis",
                    "criterion": "Wegener's granulomatosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Sjögren's syndrome",
                    "criterion": "Sjögren's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Guillain-Barré syndrome",
                    "criterion": "Guillain-Barré syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "multiple sclerosis",
                    "criterion": "multiple sclerosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 6. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.",
            "criterions": [
                {
                    "exact_snippets": "A history of idiopathic pulmonary fibrosis",
                    "criterion": "idiopathic pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of ... organizing pneumonia (such as obliterative bronchiolitis)",
                    "criterion": "organizing pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of ... drug-induced pneumonia",
                    "criterion": "drug-induced pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of ... idiopathic pneumonia",
                    "criterion": "idiopathic pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of active pneumonia on chest CT scans at screening",
                    "criterion": "active pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 7. Active pulmonary tuberculosis.",
            "criterions": [
                {
                    "exact_snippets": "Active pulmonary tuberculosis",
                    "criterion": "pulmonary tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 8. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.",
            "criterions": [
                {
                    "exact_snippets": "Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment",
                    "criterion": "severe cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months prior to the start of study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "NYHA class II or higher heart disease",
                    "criterion": "NYHA class heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable arrhythmias",
                    "criterion": "unstable arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 9. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.",
            "criterions": [
                {
                    "exact_snippets": "underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment",
                    "criterion": "significant surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected to require significant surgical procedures during the study period",
                    "criterion": "significant surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "expected to require during study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 10. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death , such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.",
            "criterions": [
                {
                    "exact_snippets": "malignant tumors other than breast cancer within the last 5 years",
                    "criterion": "malignant tumors other than breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 5 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "malignancies in the study that have negligible risks of metastasis or death",
                    "criterion": "malignancies in the study",
                    "requirements": [
                        {
                            "requirement_type": "risk of metastasis or death",
                            "expected_value": "negligible"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment adequacy",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ductal carcinoma in situ",
                    "criterion": "ductal carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I uterine cancer",
                    "criterion": "stage I uterine cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "I"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 11. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.",
            "criterions": [
                {
                    "exact_snippets": "severe infections within 4 weeks prior to the start of the study treatment",
                    "criterion": "severe infections",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 4 weeks prior to the start of the study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring hospitalization due to infections",
                    "criterion": "hospitalization due to infections",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bacteremia",
                    "criterion": "bacteremia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe pneumonia",
                    "criterion": "severe pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any active infection that may impact patient safety",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "impact on patient safety",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 12. Patients who have previously received allogeneic stem cell or solid organ transplants.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have previously received allogeneic stem cell ... transplants.",
                    "criterion": "allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who have previously received ... solid organ transplants.",
                    "criterion": "solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 13. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.",
            "criterions": [
                {
                    "exact_snippets": "Any other diseases",
                    "criterion": "other diseases",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interpretation impact",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk of complications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic dysfunctions",
                    "criterion": "metabolic dysfunctions",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interpretation impact",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk of complications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physical examination abnormalities",
                    "criterion": "physical examination abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interpretation impact",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk of complications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical laboratory abnormalities",
                    "criterion": "clinical laboratory abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interpretation impact",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "risk of complications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}