{
    "info": {
        "nct_id": "NCT05335473",
        "official_title": "Phase I b/ II Clinical Study of Iribrine Mesylate Plus Tucidinostat in the Treatment of HR+/HER2- Locally Relapsed or Metastatic Breast Cancer After Previous CDK4/6 Inhibitor Failure",
        "inclusion_criteria": "-\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Age ≥18 years and ≤75 years at the time of signing the informed consent; 2. The physical status score of the Eastern Oncology Consortium (ECOG) was ≤2 points; 3. Confirmed by pathology as HR+/HER2- (according to American College of Clinical Oncology/American College of Pathologists guidelines) (Note: HER2 feminine is defined as ①IH0; IHC1+; Locally advanced or metastatic IHC2+ : FISH-) Sexual female breast cancer patients, not suitable for radical treatment of the purpose of surgery or radiotherapy; 4. Proving that endocrine therapy is difficult to treat or resistant to endocrine therapy; 5. Used 1-2 chemotherapy regiments in the advanced stage; 6. Received at least one taxane and CDK4/6 inhibitor (including unmarketed ones) at any stage; 7. If a patient in the early stage relapses within 12 months of adjuvant chemotherapy (new), it can be counted as one advanced chemotherapy line Number; 8. The total number of treatment lines in the late stage ≤3 lines; 9. At least 1 measurable lesion was present according to RECIST1.1; External radiation therapy (EBRT) or local area treatment (such as radiofrequency ablation) of the lesion must show evidence of disease progression (according to RECIST 1.1), can be used as target lesion; 10. Life expectancy ≥3 months; 11. The functional level of the organ must meet the following requirements:\n\n1. Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days); PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used); Hb≥100 g/L(no corrective treatment was used within 7 days);\n2. Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤3 x ULN; Glutamine transpeptidase GGT≤2.5×ULN; If liver metastasis exists, ALT and/or AST≤5×ULN; Glutamine transpeptidase GGT≤5×ULN; Urea, urea nitrogen (BUN), creatinine (Cr) ≤1.5×ULN;\n3. Cardiac color ultrasound: LVEF≥50%;\n4. 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms, female<470 ms.\n\n11. The time interval between the end of the last antitumor therapy and the first administration of the study drug meets the following requirements: surgery The interval must be ≥4 weeks (minor surgery, such as tumor biopsy, thoracopuncture, or intravenous catheter placement, is not limited); Recovery of adverse reactions to previous antitumor therapy (radiotherapy, chemotherapy, targeting) to ≤ Grade 1 (phase Ib required patients A washout period of 7-14 days after natural recovery without symptomatic drugs or symptomatic treatment).\n\n12. Voluntarily agrees to and signs a written informed consent and is willing and able to comply with all aspects of the test protocol,The patient may withdraw consent at any time without prejudice to his rights and interests.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "-\n\nSubjects will not be enrolled if they meet any of the following criteria:\n\n1. Receiving neoadjuvant or adjuvant therapy containing Iribulin within one year prior to treatment initiation;\n2. Patients with recurrent or metastatic breast cancer who have failed or responded to previous treatment with Iribulin (achieved CR/PR/SD), but tumor progression within 6 months after cessation of aribulin therapy;\n3. Patients who have received any HDAC inhibitor at any time in the past;\n4. Participated in clinical trials of unmarketed drugs within 4 weeks before enrollment;\n5. Exclude subjects with brain or subdural metastases. Unless the patient has completed local treatment and is stable on imaging Those who had maintained the condition for at least 4 weeks, had stopped systemic sex hormone therapy and had stable symptoms for at least 4 weeks were included(By comparing head enhancement CT or MRI performed during screening with head enhancement performed at least 4 weeks earlier CT or MRI to determine the stability of the lesion);\n6. Before screening, the toxicity of the original treatment regimen had not recovered, and there were still more than grade 1 toxic reactions (CTCAE5.0);\n7. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow,Chronic diarrhea, intestinal obstruction, etc);\n8. Severe/uncontrolled disease or active infection;\n9. Severe cardiovascular injury (greater than NYHA Class II congestive heart failure) History), unstable angina pectoris or myocardial infarction within the past 6 months, or severe arrhythmia;\n10. Subjects with allograft requiring immunosuppressive therapy.\n11. Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal); Known human immunodeficiency disease Hiv-positive subjects.\n12. Had other malignancies within the previous 5 years, excluding cured papillary thyroid carcinoma and in situ cervix Carcinoma, skin basal cell carcinoma or skin squamous cell carcinoma;\n13. Subjects with hypersensitivity to softin B and/or softin B chemical derivatives.\n14. Pregnant and lactating women, fertile women who have tested positive for baseline pregnancy tests,or were unwilling to use effective contraception throughout the trial period and within 90 days after the last administration of the study drug age patients;\n15. The investigator considers the subject unfit for any medical condition to enter the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Age ≥18 years and ≤75 years at the time of signing the informed consent; 2. The physical status score of the Eastern Oncology Consortium (ECOG) was ≤2 points; 3. Confirmed by pathology as HR+/HER2- (according to American College of Clinical Oncology/American College of Pathologists guidelines) (Note: HER2 feminine is defined as ①IH0; IHC1+; Locally advanced or metastatic IHC2+ : FISH-) Sexual female breast cancer patients, not suitable for radical treatment of the purpose of surgery or radiotherapy; 4. Proving that endocrine therapy is difficult to treat or resistant to endocrine therapy; 5. Used 1-2 chemotherapy regiments in the advanced stage; 6. Received at least one taxane and CDK4/6 inhibitor (including unmarketed ones) at any stage; 7. If a patient in the early stage relapses within 12 months of adjuvant chemotherapy (new), it can be counted as one advanced chemotherapy line Number; 8. The total number of treatment lines in the late stage ≤3 lines; 9. At least 1 measurable lesion was present according to RECIST1.1; External radiation therapy (EBRT) or local area treatment (such as radiofrequency ablation) of the lesion must show evidence of disease progression (according to RECIST 1.1), can be used as target lesion; 10. Life expectancy ≥3 months; 11. The functional level of the organ must meet the following requirements:",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years and ≤75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "physical status score of the Eastern Oncology Consortium (ECOG) was ≤2 points",
                        "criterion": "ECOG physical status score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "points"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Confirmed by pathology as HR+/HER2-",
                        "criterion": "pathology confirmation",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "HR+/HER2-"
                        }
                    },
                    {
                        "exact_snippets": "Sexual female breast cancer patients",
                        "criterion": "gender and cancer type",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Sexual female breast cancer patients",
                        "criterion": "gender and cancer type",
                        "requirement": {
                            "requirement_type": "cancer type",
                            "expected_value": "breast cancer"
                        }
                    },
                    {
                        "exact_snippets": "not suitable for radical treatment of the purpose of surgery or radiotherapy",
                        "criterion": "suitability for radical treatment",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "endocrine therapy is difficult to treat or resistant to endocrine therapy",
                        "criterion": "endocrine therapy resistance",
                        "requirement": {
                            "requirement_type": "resistance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Used 1-2 chemotherapy regiments in the advanced stage",
                        "criterion": "chemotherapy regimens in advanced stage",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimens"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "regimens"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received at least one taxane and CDK4/6 inhibitor",
                        "criterion": "taxane and CDK4/6 inhibitor receipt",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "If a patient in the early stage relapses within 12 months of adjuvant chemotherapy",
                        "criterion": "early stage relapse after adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total number of treatment lines in the late stage ≤3 lines",
                        "criterion": "treatment lines in late stage",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    },
                    {
                        "exact_snippets": "At least 1 measurable lesion was present according to RECIST1.1",
                        "criterion": "measurable lesion presence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Life expectancy ≥3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Age ≥18 years and ≤75 years",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 18,
                                                "unit": "years"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 75,
                                                "unit": "years"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "physical status score of the Eastern Oncology Consortium (ECOG) was ≤2 points",
                                "criterion": "ECOG physical status score",
                                "requirement": {
                                    "requirement_type": "score",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "points"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Confirmed by pathology as HR+/HER2-",
                                "criterion": "pathology confirmation",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "HR+/HER2-"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Sexual female breast cancer patients",
                                        "criterion": "gender and cancer type",
                                        "requirement": {
                                            "requirement_type": "gender",
                                            "expected_value": "female"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Sexual female breast cancer patients",
                                        "criterion": "gender and cancer type",
                                        "requirement": {
                                            "requirement_type": "cancer type",
                                            "expected_value": "breast cancer"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "not suitable for radical treatment of the purpose of surgery or radiotherapy",
                                "criterion": "suitability for radical treatment",
                                "requirement": {
                                    "requirement_type": "suitability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "endocrine therapy is difficult to treat or resistant to endocrine therapy",
                                "criterion": "endocrine therapy resistance",
                                "requirement": {
                                    "requirement_type": "resistance",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Used 1-2 chemotherapy regiments in the advanced stage",
                                "criterion": "chemotherapy regimens in advanced stage",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "regimens"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "regimens"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Received at least one taxane and CDK4/6 inhibitor",
                                "criterion": "taxane and CDK4/6 inhibitor receipt",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "total number of treatment lines in the late stage ≤3 lines",
                                "criterion": "treatment lines in late stage",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "lines"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "At least 1 measurable lesion was present according to RECIST1.1",
                                "criterion": "measurable lesion presence",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Life expectancy ≥3 months",
                                "criterion": "life expectancy",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "If a patient in the early stage relapses within 12 months of adjuvant chemotherapy",
                            "criterion": "early stage relapse after adjuvant chemotherapy",
                            "requirement": {
                                "requirement_type": "time frame",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 12,
                                    "unit": "months"
                                }
                            }
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days); PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used); Hb≥100 g/L(no corrective treatment was used within 7 days);",
                "criterions": [
                    {
                        "exact_snippets": "Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days)",
                        "criterion": "ANC (Absolute Neutrophil Count)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days)",
                        "criterion": "ANC (Absolute Neutrophil Count)",
                        "requirement": {
                            "requirement_type": "treatment restriction",
                            "expected_value": "no growth factor used within 14 days"
                        }
                    },
                    {
                        "exact_snippets": "Blood routine: ... PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used)",
                        "criterion": "PLT (Platelet Count)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Blood routine: ... PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used)",
                        "criterion": "PLT (Platelet Count)",
                        "requirement": {
                            "requirement_type": "treatment restriction",
                            "expected_value": "No corrective treatment was used"
                        }
                    },
                    {
                        "exact_snippets": "Blood routine: ... Hb≥100 g/L(no corrective treatment was used within 7 days)",
                        "criterion": "Hb (Hemoglobin)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Blood routine: ... Hb≥100 g/L(no corrective treatment was used within 7 days)",
                        "criterion": "Hb (Hemoglobin)",
                        "requirement": {
                            "requirement_type": "treatment restriction",
                            "expected_value": "no corrective treatment was used within 7 days"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days)",
                                "criterion": "ANC (Absolute Neutrophil Count)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "×10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Blood routine: ANC≥1.5×109/L (no growth factor used within 14 days)",
                                "criterion": "ANC (Absolute Neutrophil Count)",
                                "requirement": {
                                    "requirement_type": "treatment restriction",
                                    "expected_value": "no growth factor used within 14 days"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Blood routine: ... PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used)",
                                "criterion": "PLT (Platelet Count)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "×10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Blood routine: ... PLT 100 x 109 or higher/L (within 7 daysNo corrective treatment was used)",
                                "criterion": "PLT (Platelet Count)",
                                "requirement": {
                                    "requirement_type": "treatment restriction",
                                    "expected_value": "No corrective treatment was used"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Blood routine: ... Hb≥100 g/L(no corrective treatment was used within 7 days)",
                                "criterion": "Hb (Hemoglobin)",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "g/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Blood routine: ... Hb≥100 g/L(no corrective treatment was used within 7 days)",
                                "criterion": "Hb (Hemoglobin)",
                                "requirement": {
                                    "requirement_type": "treatment restriction",
                                    "expected_value": "no corrective treatment was used within 7 days"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤3 x ULN; Glutamine transpeptidase GGT≤2.5×ULN; If liver metastasis exists, ALT and/or AST≤5×ULN; Glutamine transpeptidase GGT≤5×ULN; Urea, urea nitrogen (BUN), creatinine (Cr) ≤1.5×ULN;",
                "criterions": [
                    {
                        "exact_snippets": "TBIL≤1.5×ULN",
                        "criterion": "total bilirubin (TBIL)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT and AST≤3 x ULN",
                        "criterion": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Glutamine transpeptidase GGT≤2.5×ULN",
                        "criterion": "glutamine transpeptidase (GGT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If liver metastasis exists, ALT and/or AST≤5×ULN",
                        "criterion": "alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with liver metastasis",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If liver metastasis exists, ... Glutamine transpeptidase GGT≤5×ULN",
                        "criterion": "glutamine transpeptidase (GGT) with liver metastasis",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Urea, urea nitrogen (BUN), creatinine (Cr) ≤1.5×ULN",
                        "criterion": "urea, urea nitrogen (BUN), creatinine (Cr)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "TBIL≤1.5×ULN",
                                "criterion": "total bilirubin (TBIL)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "ALT and AST≤3 x ULN",
                                "criterion": "alanine aminotransferase (ALT) and aspartate aminotransferase (AST)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Glutamine transpeptidase GGT≤2.5×ULN",
                                "criterion": "glutamine transpeptidase (GGT)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Urea, urea nitrogen (BUN), creatinine (Cr) ≤1.5×ULN",
                                "criterion": "urea, urea nitrogen (BUN), creatinine (Cr)",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "If liver metastasis exists, ALT and/or AST≤5×ULN",
                            "criterion": "liver metastasis",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "If liver metastasis exists, ALT and/or AST≤5×ULN",
                                    "criterion": "alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with liver metastasis",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "If liver metastasis exists, ... Glutamine transpeptidase GGT≤5×ULN",
                                    "criterion": "glutamine transpeptidase (GGT) with liver metastasis",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "ULN"
                                        }
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Cardiac color ultrasound: LVEF≥50%;",
                "criterions": [
                    {
                        "exact_snippets": "Cardiac color ultrasound: LVEF≥50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cardiac color ultrasound: LVEF≥50%",
                        "criterion": "left ventricular ejection fraction (LVEF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms, female<470 ms.",
                "criterions": [
                    {
                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms",
                        "criterion": "QT interval (QTcF) for male",
                        "requirement": {
                            "requirement_type": "corrected by Fridericia method",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms",
                        "criterion": "QT interval (QTcF) for male",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method ... female<470 ms",
                        "criterion": "QT interval (QTcF) for female",
                        "requirement": {
                            "requirement_type": "corrected by Fridericia method",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method ... female<470 ms",
                        "criterion": "QT interval (QTcF) for female",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms",
                                        "criterion": "QT interval (QTcF) for male",
                                        "requirement": {
                                            "requirement_type": "corrected by Fridericia method",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method for male <450ms",
                                        "criterion": "QT interval (QTcF) for male",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 450,
                                                "unit": "ms"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method ... female<470 ms",
                                        "criterion": "QT interval (QTcF) for female",
                                        "requirement": {
                                            "requirement_type": "corrected by Fridericia method",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method ... female<470 ms",
                                        "criterion": "QT interval (QTcF) for female",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 470,
                                                "unit": "ms"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. The time interval between the end of the last antitumor therapy and the first administration of the study drug meets the following requirements: surgery The interval must be ≥4 weeks (minor surgery, such as tumor biopsy, thoracopuncture, or intravenous catheter placement, is not limited); Recovery of adverse reactions to previous antitumor therapy (radiotherapy, chemotherapy, targeting) to ≤ Grade 1 (phase Ib required patients A washout period of 7-14 days after natural recovery without symptomatic drugs or symptomatic treatment).",
                "criterions": [
                    {
                        "exact_snippets": "The time interval between the end of the last antitumor therapy and the first administration of the study drug ... surgery The interval must be ≥4 weeks",
                        "criterion": "time interval between last antitumor therapy and study drug administration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Recovery of adverse reactions to previous antitumor therapy ... to ≤ Grade 1",
                        "criterion": "recovery of adverse reactions to previous antitumor therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "phase Ib required patients A washout period of 7-14 days",
                        "criterion": "washout period for phase Ib patients",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 7,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "The time interval between the end of the last antitumor therapy and the first administration of the study drug ... surgery The interval must be ≥4 weeks",
                                        "criterion": "time interval between last antitumor therapy and study drug administration",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Recovery of adverse reactions to previous antitumor therapy ... to ≤ Grade 1",
                                        "criterion": "recovery of adverse reactions to previous antitumor therapy",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 1,
                                                "unit": "Grade"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "condition": {
                                    "exact_snippets": "phase Ib required patients A washout period of 7-14 days",
                                    "criterion": "washout period for phase Ib patients",
                                    "requirement": {
                                        "requirement_type": "duration",
                                        "expected_value": {
                                            "comparisons": [
                                                {
                                                    "operator": ">=",
                                                    "value": 7,
                                                    "unit": "days"
                                                },
                                                {
                                                    "operator": "<=",
                                                    "value": 14,
                                                    "unit": "days"
                                                }
                                            ]
                                        }
                                    }
                                },
                                "then_criteria": null,
                                "else_criteria": null
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Voluntarily agrees to and signs a written informed consent and is willing and able to comply with all aspects of the test protocol,The patient may withdraw consent at any time without prejudice to his rights and interests.",
                "criterions": [
                    {
                        "exact_snippets": "Voluntarily agrees to and signs a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to comply with all aspects of the test protocol",
                        "criterion": "compliance with test protocol",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Voluntarily agrees to and signs a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willing and able to comply with all aspects of the test protocol",
                        "criterion": "compliance with test protocol",
                        "requirement": {
                            "requirement_type": "willingness and ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "-",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Subjects must meet all of the following criteria to be enrolled:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Receiving neoadjuvant or adjuvant therapy containing Iribulin within one year prior to treatment initiation;",
                "criterions": [
                    {
                        "exact_snippets": "Receiving neoadjuvant or adjuvant therapy containing Iribulin within one year prior to treatment initiation",
                        "criterion": "neoadjuvant or adjuvant therapy containing Iribulin",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Receiving neoadjuvant or adjuvant therapy containing Iribulin within one year prior to treatment initiation",
                        "criterion": "neoadjuvant or adjuvant therapy containing Iribulin",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients with recurrent or metastatic breast cancer who have failed or responded to previous treatment with Iribulin (achieved CR/PR/SD), but tumor progression within 6 months after cessation of aribulin therapy;",
                "criterions": [
                    {
                        "exact_snippets": "recurrent or metastatic breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recurrent or metastatic breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "failed or responded to previous treatment with Iribulin",
                        "criterion": "previous treatment with Iribulin",
                        "requirement": {
                            "requirement_type": "response",
                            "expected_value": [
                                "failed",
                                "responded"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "achieved CR/PR/SD",
                        "criterion": "treatment response",
                        "requirement": {
                            "requirement_type": "response type",
                            "expected_value": [
                                "CR",
                                "PR",
                                "SD"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "tumor progression within 6 months after cessation of aribulin therapy",
                        "criterion": "tumor progression",
                        "requirement": {
                            "requirement_type": "time since cessation of aribulin therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "recurrent or metastatic breast cancer",
                                        "criterion": "breast cancer",
                                        "requirement": {
                                            "requirement_type": "recurrence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "recurrent or metastatic breast cancer",
                                        "criterion": "breast cancer",
                                        "requirement": {
                                            "requirement_type": "metastasis",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "failed or responded to previous treatment with Iribulin",
                                "criterion": "previous treatment with Iribulin",
                                "requirement": {
                                    "requirement_type": "response",
                                    "expected_value": [
                                        "failed",
                                        "responded"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "achieved CR/PR/SD",
                                "criterion": "treatment response",
                                "requirement": {
                                    "requirement_type": "response type",
                                    "expected_value": [
                                        "CR",
                                        "PR",
                                        "SD"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "tumor progression within 6 months after cessation of aribulin therapy",
                        "criterion": "tumor progression",
                        "requirement": {
                            "requirement_type": "time since cessation of aribulin therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Patients who have received any HDAC inhibitor at any time in the past;",
                "criterions": [
                    {
                        "exact_snippets": "Patients who have received any HDAC inhibitor at any time in the past",
                        "criterion": "HDAC inhibitor treatment",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients who have received any HDAC inhibitor at any time in the past",
                    "criterion": "HDAC inhibitor treatment",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Participated in clinical trials of unmarketed drugs within 4 weeks before enrollment;",
                "criterions": [
                    {
                        "exact_snippets": "Participated in clinical trials of unmarketed drugs within 4 weeks before enrollment",
                        "criterion": "participation in clinical trials of unmarketed drugs",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Participated in clinical trials of unmarketed drugs within 4 weeks before enrollment",
                    "criterion": "participation in clinical trials of unmarketed drugs",
                    "requirement": {
                        "requirement_type": "time frame",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": "<=",
                                    "value": 4,
                                    "unit": "weeks"
                                }
                            ]
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "5. Exclude subjects with brain or subdural metastases. Unless the patient has completed local treatment and is stable on imaging Those who had maintained the condition for at least 4 weeks, had stopped systemic sex hormone therapy and had stable symptoms for at least 4 weeks were included(By comparing head enhancement CT or MRI performed during screening with head enhancement performed at least 4 weeks earlier CT or MRI to determine the stability of the lesion);",
                "criterions": [
                    {
                        "exact_snippets": "Exclude subjects with brain or subdural metastases.",
                        "criterion": "brain or subdural metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "completed local treatment",
                        "criterion": "local treatment",
                        "requirement": {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable on imaging",
                        "criterion": "stability on imaging",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "maintained the condition for at least 4 weeks",
                        "criterion": "condition maintenance",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "stopped systemic sex hormone therapy",
                        "criterion": "systemic sex hormone therapy",
                        "requirement": {
                            "requirement_type": "cessation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "stable symptoms for at least 4 weeks",
                        "criterion": "symptom stability",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "comparing head enhancement CT or MRI performed during screening with head enhancement performed at least 4 weeks earlier CT or MRI to determine the stability of the lesion",
                        "criterion": "lesion stability",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": "stable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Exclude subjects with brain or subdural metastases.",
                    "criterion": "brain or subdural metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "completed local treatment",
                            "criterion": "local treatment",
                            "requirement": {
                                "requirement_type": "completion",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "stable on imaging",
                            "criterion": "stability on imaging",
                            "requirement": {
                                "requirement_type": "stability",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "maintained the condition for at least 4 weeks",
                            "criterion": "condition maintenance",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 4,
                                    "unit": "weeks"
                                }
                            }
                        },
                        {
                            "exact_snippets": "stopped systemic sex hormone therapy",
                            "criterion": "systemic sex hormone therapy",
                            "requirement": {
                                "requirement_type": "cessation",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "stable symptoms for at least 4 weeks",
                            "criterion": "symptom stability",
                            "requirement": {
                                "requirement_type": "duration",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 4,
                                    "unit": "weeks"
                                }
                            }
                        },
                        {
                            "exact_snippets": "comparing head enhancement CT or MRI performed during screening with head enhancement performed at least 4 weeks earlier CT or MRI to determine the stability of the lesion",
                            "criterion": "lesion stability",
                            "requirement": {
                                "requirement_type": "comparison",
                                "expected_value": "stable"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "6. Before screening, the toxicity of the original treatment regimen had not recovered, and there were still more than grade 1 toxic reactions (CTCAE5.0);",
                "criterions": [
                    {
                        "exact_snippets": "toxicity of the original treatment regimen had not recovered",
                        "criterion": "toxicity recovery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "more than grade 1 toxic reactions (CTCAE5.0)",
                        "criterion": "toxic reactions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "toxicity of the original treatment regimen had not recovered",
                        "criterion": "toxicity recovery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "more than grade 1 toxic reactions (CTCAE5.0)",
                        "criterion": "toxic reactions",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow,Chronic diarrhea, intestinal obstruction, etc);",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant gastrointestinal abnormalities",
                        "criterion": "gastrointestinal abnormalities",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "inability to swallow",
                        "criterion": "ability to swallow",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Chronic diarrhea",
                        "criterion": "chronic diarrhea",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intestinal obstruction",
                        "criterion": "intestinal obstruction",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinically significant gastrointestinal abnormalities",
                                "criterion": "gastrointestinal abnormalities",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "inability to swallow",
                                        "criterion": "ability to swallow",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "Chronic diarrhea",
                                        "criterion": "chronic diarrhea",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "intestinal obstruction",
                                        "criterion": "intestinal obstruction",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Severe/uncontrolled disease or active infection;",
                "criterions": [
                    {
                        "exact_snippets": "Severe/uncontrolled disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "Severe/uncontrolled disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe/uncontrolled disease",
                                "criterion": "disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            },
                            {
                                "exact_snippets": "Severe/uncontrolled disease",
                                "criterion": "disease",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "active infection",
                        "criterion": "infection",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Severe cardiovascular injury (greater than NYHA Class II congestive heart failure) History), unstable angina pectoris or myocardial infarction within the past 6 months, or severe arrhythmia;",
                "criterions": [
                    {
                        "exact_snippets": "Severe cardiovascular injury (greater than NYHA Class II congestive heart failure)",
                        "criterion": "cardiovascular injury",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "greater than NYHA Class II congestive heart failure"
                        }
                    },
                    {
                        "exact_snippets": "unstable angina pectoris",
                        "criterion": "angina pectoris",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    },
                    {
                        "exact_snippets": "myocardial infarction within the past 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "severe arrhythmia",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Severe cardiovascular injury (greater than NYHA Class II congestive heart failure)",
                                "criterion": "cardiovascular injury",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "greater than NYHA Class II congestive heart failure"
                                }
                            },
                            {
                                "exact_snippets": "unstable angina pectoris",
                                "criterion": "angina pectoris",
                                "requirement": {
                                    "requirement_type": "stability",
                                    "expected_value": "unstable"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "myocardial infarction within the past 6 months",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "severe arrhythmia",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Subjects with allograft requiring immunosuppressive therapy.",
                "criterions": [
                    {
                        "exact_snippets": "allograft requiring immunosuppressive therapy",
                        "criterion": "allograft",
                        "requirement": {
                            "requirement_type": "immunosuppressive therapy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "allograft requiring immunosuppressive therapy",
                    "criterion": "allograft",
                    "requirement": {
                        "requirement_type": "immunosuppressive therapy",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal); Known human immunodeficiency disease Hiv-positive subjects.",
                "criterions": [
                    {
                        "exact_snippets": "Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml",
                        "criterion": "active hepatitis B",
                        "requirement": {
                            "requirement_type": "HBsAg status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml",
                        "criterion": "active hepatitis B",
                        "requirement": {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "IU/ml"
                            }
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis ... cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal",
                        "criterion": "active hepatitis C",
                        "requirement": {
                            "requirement_type": "HCV antibody status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active hepatitis ... cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal",
                        "criterion": "active hepatitis C",
                        "requirement": {
                            "requirement_type": "HCV virus copy number",
                            "expected_value": "> upper limit of normal"
                        }
                    },
                    {
                        "exact_snippets": "Known human immunodeficiency disease Hiv-positive subjects",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "HIV status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml",
                                        "criterion": "active hepatitis B",
                                        "requirement": {
                                            "requirement_type": "HBsAg status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Subject has active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml",
                                        "criterion": "active hepatitis B",
                                        "requirement": {
                                            "requirement_type": "HBV DNA level",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 500,
                                                "unit": "IU/ml"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "active hepatitis ... cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal",
                                        "criterion": "active hepatitis C",
                                        "requirement": {
                                            "requirement_type": "HCV antibody status",
                                            "expected_value": "positive"
                                        }
                                    },
                                    {
                                        "exact_snippets": "active hepatitis ... cLiver reference: HCV antibody positive and HCV virus copy number > upper limit of normal",
                                        "criterion": "active hepatitis C",
                                        "requirement": {
                                            "requirement_type": "HCV virus copy number",
                                            "expected_value": "> upper limit of normal"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Known human immunodeficiency disease Hiv-positive subjects",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "HIV status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Had other malignancies within the previous 5 years, excluding cured papillary thyroid carcinoma and in situ cervix Carcinoma, skin basal cell carcinoma or skin squamous cell carcinoma;",
                "criterions": [
                    {
                        "exact_snippets": "Had other malignancies within the previous 5 years",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Had other malignancies within the previous 5 years",
                        "criterion": "other malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "excluding cured papillary thyroid carcinoma",
                        "criterion": "cured papillary thyroid carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding ... in situ cervix Carcinoma",
                        "criterion": "in situ cervix Carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding ... skin basal cell carcinoma",
                        "criterion": "skin basal cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "excluding ... skin squamous cell carcinoma",
                        "criterion": "skin squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Had other malignancies within the previous 5 years",
                                "criterion": "other malignancies",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Had other malignancies within the previous 5 years",
                                "criterion": "other malignancies",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "excluding cured papillary thyroid carcinoma",
                                    "criterion": "cured papillary thyroid carcinoma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "excluding ... in situ cervix Carcinoma",
                                    "criterion": "in situ cervix Carcinoma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "excluding ... skin basal cell carcinoma",
                                    "criterion": "skin basal cell carcinoma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "excluding ... skin squamous cell carcinoma",
                                    "criterion": "skin squamous cell carcinoma",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Subjects with hypersensitivity to softin B and/or softin B chemical derivatives.",
                "criterions": [
                    {
                        "exact_snippets": "hypersensitivity to softin B",
                        "criterion": "hypersensitivity to softin B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to ... softin B chemical derivatives",
                        "criterion": "hypersensitivity to softin B chemical derivatives",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "hypersensitivity to softin B",
                        "criterion": "hypersensitivity to softin B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to ... softin B chemical derivatives",
                        "criterion": "hypersensitivity to softin B chemical derivatives",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Pregnant and lactating women, fertile women who have tested positive for baseline pregnancy tests,or were unwilling to use effective contraception throughout the trial period and within 90 days after the last administration of the study drug age patients;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "fertile women who have tested positive for baseline pregnancy tests",
                        "criterion": "baseline pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "unwilling to use effective contraception throughout the trial period and within 90 days after the last administration of the study drug",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lactating women",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "fertile women who have tested positive for baseline pregnancy tests",
                        "criterion": "baseline pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "unwilling to use effective contraception throughout the trial period and within 90 days after the last administration of the study drug",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. The investigator considers the subject unfit for any medical condition to enter the study.",
                "criterions": [
                    {
                        "exact_snippets": "The investigator considers the subject unfit for any medical condition",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "The investigator considers the subject unfit for any medical condition",
                    "criterion": "medical condition",
                    "requirement": {
                        "requirement_type": "fitness",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "-",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Subjects will not be enrolled if they meet any of the following criteria:",
                "criterions": []
            },
            "logical_structure": {
                "or_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}