{
    "info": {
        "nct_id": "NCT06768931",
        "official_title": "A Multicenter, Randomized Controlled Phase II Clinical Study of Standard Neoadjuvant Therapy Combined with Biolosion (oral Probiotic Compound Preparation) in Triple-negative Breast Cancer",
        "inclusion_criteria": "1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;\n2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;\n3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2~cT4, cN0~N3, and patients with no distant metastasis as evaluated by imaging;\n4. Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;\n5. ECOG PS: 0-2;\n6. Expected survival of ≥12 weeks;\n7. Major organ function levels must meet the following criteria:\n\n1) Hematological examination standards must meet: ANC≥1.5×10^9/L, PLT≥75×10^9/L, Hb≥90g/L (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction) 2) Biochemical examination must meet the following standards: TBIL<1.5×ULN, ALT, AST<2.5×ULN, for patients with liver metastasis, ALT, AST may be <5×ULN, BUN and Cr≤1×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug.\n\n9. Participants voluntarily join this study, demonstrate good compliance, and cooperate with follow-up.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. There is a clear distant transfer;\n2. A history of autoimmune diseases;\n3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.\n4. Previous treatment with immune checkpoint inhibitors;\n5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;\n6. Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;\n7. Currently receiving other antitumor treatments;\n8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that, in the investigator's assessment, would increase the risk associated with the administration of the study drug or interfere with the interpretation of study results.\n9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.\n10. A history of epilepsy or seizure-inducing states;\n11. Pregnant or breastfeeding patients;\n12. Poor compliance or inability to undergo normal follow-up;\n13. Individuals allergic to the study drug;\n14. Diagnosis of other malignancies within the past 5 years, with the exception of: surgically removed non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally curative prostate cancer, surgically treated ductal carcinoma in situ, or malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years;\n15. The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;",
                "criterions": [
                    {
                        "exact_snippets": "Women aged 1.18 years and above",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.18,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "diagnosed with triple-negative breast cancer",
                        "criterion": "triple-negative breast cancer diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ER≤10%",
                        "criterion": "estrogen receptor (ER) status",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PR≤10%",
                        "criterion": "progesterone receptor (PR) status",
                        "requirement": {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "HER-2 negative",
                        "criterion": "HER-2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "diagnosed with triple-negative breast cancer",
                                "criterion": "triple-negative breast cancer diagnosis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "ER≤10%",
                                "criterion": "estrogen receptor (ER) status",
                                "requirement": {
                                    "requirement_type": "percentage",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "PR≤10%",
                                "criterion": "progesterone receptor (PR) status",
                                "requirement": {
                                    "requirement_type": "percentage",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "%"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "HER-2 negative",
                                "criterion": "HER-2 status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "negative"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Women aged 1.18 years and above",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;",
                "criterions": [
                    {
                        "exact_snippets": "Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available",
                        "criterion": "tumor specimens",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 expression testing",
                        "criterion": "PD-L1 expression",
                        "requirement": {
                            "requirement_type": "testing",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available",
                        "criterion": "tumor specimens",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 expression testing",
                        "criterion": "PD-L1 expression",
                        "requirement": {
                            "requirement_type": "testing",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2~cT4, cN0~N3, and patients with no distant metastasis as evaluated by imaging;",
                "criterions": [
                    {
                        "exact_snippets": "indications for neoadjuvant chemotherapy",
                        "criterion": "indications for neoadjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "staging from IIA to IIIC",
                        "criterion": "cancer staging",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2.2,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3.3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "imaging or pathological evaluation of cT1c, N1-3, or cT2~cT4, cN0~N3",
                        "criterion": "tumor and node staging",
                        "requirement": {
                            "requirement_type": "staging",
                            "expected_value": [
                                "cT1c",
                                "N1-3",
                                "cT2~cT4",
                                "cN0~N3"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "patients with no distant metastasis as evaluated by imaging",
                        "criterion": "distant metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "indications for neoadjuvant chemotherapy",
                                                "criterion": "indications for neoadjuvant chemotherapy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "staging from IIA to IIIC",
                                                "criterion": "cancer staging",
                                                "requirement": {
                                                    "requirement_type": "range",
                                                    "expected_value": {
                                                        "comparisons": [
                                                            {
                                                                "operator": ">=",
                                                                "value": 2.2,
                                                                "unit": "stage"
                                                            },
                                                            {
                                                                "operator": "<=",
                                                                "value": 3.3,
                                                                "unit": "stage"
                                                            }
                                                        ]
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "imaging or pathological evaluation of cT1c, N1-3, or cT2~cT4, cN0~N3",
                                        "criterion": "tumor and node staging",
                                        "requirement": {
                                            "requirement_type": "staging",
                                            "expected_value": [
                                                "cT1c",
                                                "N1-3",
                                                "cT2~cT4",
                                                "cN0~N3"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "patients with no distant metastasis as evaluated by imaging",
                                "criterion": "distant metastasis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;",
                "criterions": [
                    {
                        "exact_snippets": "Patients must not have received chemotherapy ... for advanced breast cancer",
                        "criterion": "chemotherapy for advanced breast cancer",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have received ... targeted therapy for advanced breast cancer",
                        "criterion": "targeted therapy for advanced breast cancer",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must not have received chemotherapy ... for advanced breast cancer",
                        "criterion": "chemotherapy for advanced breast cancer",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients must not have received ... targeted therapy for advanced breast cancer",
                        "criterion": "targeted therapy for advanced breast cancer",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. ECOG PS: 0-2;",
                "criterions": [
                    {
                        "exact_snippets": "ECOG PS: 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG PS: 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Expected survival of ≥12 weeks;",
                "criterions": [
                    {
                        "exact_snippets": "Expected survival of ≥12 weeks;",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Expected survival of ≥12 weeks;",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Major organ function levels must meet the following criteria:",
                "criterions": [
                    {
                        "exact_snippets": "Major organ function levels",
                        "criterion": "major organ function levels",
                        "requirement": {
                            "requirement_type": "levels",
                            "expected_value": "must meet the following criteria"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Major organ function levels",
                        "criterion": "major organ function levels",
                        "requirement": {
                            "requirement_type": "levels",
                            "expected_value": "must meet the following criteria"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Participants voluntarily join this study, demonstrate good compliance, and cooperate with follow-up.",
                "criterions": [
                    {
                        "exact_snippets": "Participants voluntarily join this study",
                        "criterion": "voluntary participation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "demonstrate good compliance",
                        "criterion": "compliance",
                        "requirement": {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    },
                    {
                        "exact_snippets": "cooperate with follow-up",
                        "criterion": "follow-up cooperation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participants voluntarily join this study",
                        "criterion": "voluntary participation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "demonstrate good compliance",
                        "criterion": "compliance",
                        "requirement": {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    },
                    {
                        "exact_snippets": "cooperate with follow-up",
                        "criterion": "follow-up cooperation",
                        "requirement": {
                            "requirement_type": "presence",
                            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. There is a clear distant transfer;",
                "criterions": [
                    {
                        "exact_snippets": "clear distant transfer",
                        "criterion": "distant transfer",
                        "requirement": {
                            "requirement_type": "clarity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "clear distant transfer",
                        "criterion": "distant transfer",
                        "requirement": {
                            "requirement_type": "clarity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. A history of autoimmune diseases;",
                "criterions": [
                    {
                        "exact_snippets": "A history of autoimmune diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "A history of autoimmune diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Previous treatment with immune checkpoint inhibitors;",
                "criterions": [
                    {
                        "exact_snippets": "Previous treatment with immune checkpoint inhibitors",
                        "criterion": "treatment with immune checkpoint inhibitors",
                        "requirement": {
                            "requirement_type": "previous",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous treatment with immune checkpoint inhibitors",
                        "criterion": "treatment with immune checkpoint inhibitors",
                        "requirement": {
                            "requirement_type": "previous",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;",
                "criterions": [
                    {
                        "exact_snippets": "Received systemic immunostimulants ... within the last 4 weeks",
                        "criterion": "systemic immunostimulants",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received ... systemic corticosteroids ... within the last 4 weeks",
                        "criterion": "systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Received ... immunosuppressants within the last 4 weeks",
                        "criterion": "immunosuppressants",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received systemic immunostimulants ... within the last 4 weeks",
                                "criterion": "systemic immunostimulants",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received ... systemic corticosteroids ... within the last 4 weeks",
                                "criterion": "systemic corticosteroids",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Received ... immunosuppressants within the last 4 weeks",
                                "criterion": "immunosuppressants",
                                "requirement": {
                                    "requirement_type": "time since last administration",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;",
                "criterions": [
                    {
                        "exact_snippets": "severe underlying disease",
                        "criterion": "underlying disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "comorbidities",
                        "criterion": "comorbidities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "active infections",
                        "criterion": "infections",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "severe metabolic disorders",
                        "criterion": "metabolic disorders",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "severe underlying disease",
                                        "criterion": "underlying disease",
                                        "requirement": {
                                            "requirement_type": "severity",
                                            "expected_value": "severe"
                                        }
                                    },
                                    {
                                        "exact_snippets": "comorbidities",
                                        "criterion": "comorbidities",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "active infections",
                                        "criterion": "infections",
                                        "requirement": {
                                            "requirement_type": "activity",
                                            "expected_value": "active"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "severe metabolic disorders",
                                "criterion": "metabolic disorders",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Currently receiving other antitumor treatments;",
                "criterions": [
                    {
                        "exact_snippets": "Currently receiving other antitumor treatments",
                        "criterion": "antitumor treatments",
                        "requirement": {
                            "requirement_type": "current status",
                            "expected_value": "receiving"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Currently receiving other antitumor treatments",
                    "criterion": "antitumor treatments",
                    "requirement": {
                        "requirement_type": "current status",
                        "expected_value": "receiving"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that, in the investigator's assessment, would increase the risk associated with the administration of the study drug or interfere with the interpretation of study results.",
                "criterions": [
                    {
                        "exact_snippets": "Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.)",
                        "criterion": "comorbidities",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "increase the risk associated with the administration of the study drug",
                        "criterion": "risk associated with study drug",
                        "requirement": {
                            "requirement_type": "increase",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interfere with the interpretation of study results",
                        "criterion": "interference with study results",
                        "requirement": {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.)",
                                "criterion": "comorbidities",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "increase the risk associated with the administration of the study drug",
                                        "criterion": "risk associated with study drug",
                                        "requirement": {
                                            "requirement_type": "increase",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "interfere with the interpretation of study results",
                                        "criterion": "interference with study results",
                                        "requirement": {
                                            "requirement_type": "interference",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.",
                "criterions": [
                    {
                        "exact_snippets": "Currently using or planning to use probiotics",
                        "criterion": "probiotics usage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Currently using or planning to use ... yogurt",
                        "criterion": "yogurt consumption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Currently using or planning to use ... bacterial-enhanced foods",
                        "criterion": "bacterial-enhanced foods consumption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Currently using or planning to use probiotics",
                        "criterion": "probiotics usage",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Currently using or planning to use ... yogurt",
                        "criterion": "yogurt consumption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Currently using or planning to use ... bacterial-enhanced foods",
                        "criterion": "bacterial-enhanced foods consumption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. A history of epilepsy or seizure-inducing states;",
                "criterions": [
                    {
                        "exact_snippets": "A history of epilepsy",
                        "criterion": "epilepsy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seizure-inducing states",
                        "criterion": "seizure-inducing states",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "A history of epilepsy",
                        "criterion": "epilepsy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "seizure-inducing states",
                        "criterion": "seizure-inducing states",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Pregnant or breastfeeding patients;",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Poor compliance or inability to undergo normal follow-up;",
                "criterions": [
                    {
                        "exact_snippets": "Poor compliance",
                        "criterion": "compliance",
                        "requirement": {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    },
                    {
                        "exact_snippets": "inability to undergo normal follow-up",
                        "criterion": "ability to undergo normal follow-up",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Poor compliance",
                        "criterion": "compliance",
                        "requirement": {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    },
                    {
                        "exact_snippets": "inability to undergo normal follow-up",
                        "criterion": "ability to undergo normal follow-up",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Diagnosis of other malignancies within the past 5 years, with the exception of: surgically removed non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally curative prostate cancer, surgically treated ductal carcinoma in situ, or malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years;",
                "criterions": [
                    {
                        "exact_snippets": "Diagnosis of other malignancies within the past 5 years",
                        "criterion": "diagnosis of other malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "surgically removed non-melanoma skin cancer",
                        "criterion": "non-melanoma skin cancer",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "surgically removed"
                        }
                    },
                    {
                        "exact_snippets": "adequately treated cervical carcinoma in situ",
                        "criterion": "cervical carcinoma in situ",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "locally curative prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "locally curative"
                        }
                    },
                    {
                        "exact_snippets": "surgically treated ductal carcinoma in situ",
                        "criterion": "ductal carcinoma in situ",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "surgically treated"
                        }
                    },
                    {
                        "exact_snippets": "malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years",
                        "criterion": "malignancies diagnosed 2 years prior to randomization",
                        "requirement": {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years",
                        "criterion": "malignancies diagnosed 2 years prior to randomization",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years",
                        "criterion": "malignancies diagnosed 2 years prior to randomization",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Diagnosis of other malignancies within the past 5 years",
                            "criterion": "diagnosis of other malignancies",
                            "requirement": {
                                "requirement_type": "time frame",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 5,
                                    "unit": "years"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "or_criteria": [
                            {
                                "exact_snippets": "surgically removed non-melanoma skin cancer",
                                "criterion": "non-melanoma skin cancer",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "surgically removed"
                                }
                            },
                            {
                                "exact_snippets": "adequately treated cervical carcinoma in situ",
                                "criterion": "cervical carcinoma in situ",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "adequately treated"
                                }
                            },
                            {
                                "exact_snippets": "locally curative prostate cancer",
                                "criterion": "prostate cancer",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "locally curative"
                                }
                            },
                            {
                                "exact_snippets": "surgically treated ductal carcinoma in situ",
                                "criterion": "ductal carcinoma in situ",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "surgically treated"
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years",
                                        "criterion": "malignancies diagnosed 2 years prior to randomization",
                                        "requirement": {
                                            "requirement_type": "evidence of disease",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years",
                                        "criterion": "malignancies diagnosed 2 years prior to randomization",
                                        "requirement": {
                                            "requirement_type": "treatment",
                                            "expected_value": "untreated"
                                        }
                                    },
                                    {
                                        "exact_snippets": "malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years",
                                        "criterion": "malignancies diagnosed 2 years prior to randomization",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 2,
                                                "unit": "years"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "15. The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.",
                "criterions": [
                    {
                        "exact_snippets": "other conditions that may affect the conduct of the clinical study and the determination of study results",
                        "criterion": "other conditions",
                        "requirement": {
                            "requirement_type": "impact on study",
                            "expected_value": "may affect the conduct of the clinical study and the determination of study results"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "other conditions that may affect the conduct of the clinical study and the determination of study results",
                    "criterion": "other conditions",
                    "requirement": {
                        "requirement_type": "impact on study",
                        "expected_value": "may affect the conduct of the clinical study and the determination of study results"
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "1) Hematological examination standards must meet: ANC≥1.5×10^9/L, PLT≥75×10^9/L, Hb≥90g/L (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction) 2) Biochemical examination must meet the following standards: TBIL<1.5×ULN, ALT, AST<2.5×ULN, for patients with liver metastasis, ALT, AST may be <5×ULN, BUN and Cr≤1×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug.",
                "criterions": [
                    {
                        "exact_snippets": "ANC≥1.5×10^9/L",
                        "criterion": "ANC (Absolute Neutrophil Count)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PLT≥75×10^9/L",
                        "criterion": "PLT (Platelet Count)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hb≥90g/L",
                        "criterion": "Hb (Hemoglobin)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "g/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no blood transfusions or blood products within 14 days",
                        "criterion": "blood transfusions or blood products",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "no use of G-CSF or other hematopoietic growth factors for correction",
                        "criterion": "use of G-CSF or other hematopoietic growth factors",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "TBIL<1.5×ULN",
                        "criterion": "TBIL (Total Bilirubin)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "×ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT, AST<2.5×ULN",
                        "criterion": "ALT, AST (Alanine Aminotransferase, Aspartate Aminotransferase)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "×ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "for patients with liver metastasis, ALT, AST may be <5×ULN",
                        "criterion": "ALT, AST (Alanine Aminotransferase, Aspartate Aminotransferase) for patients with liver metastasis",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "×ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "BUN and Cr≤1×ULN",
                        "criterion": "BUN and Cr (Blood Urea Nitrogen and Creatinine)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "×ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula)",
                        "criterion": "endogenous creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Women of childbearing age must have taken reliable contraceptive measures",
                        "criterion": "contraceptive measures for women of childbearing age",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result",
                        "criterion": "pregnancy test for women of childbearing age",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug",
                        "criterion": "use of contraceptive methods during and after trial",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml)",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml)",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "hepatitis B surface antigen",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml)",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "hepatitis B core antibody",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and/or hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies/ml or ≥200 IU/ml)",
                        "criterion": "hepatitis B",
                        "requirement": {
                            "requirement_type": "hepatitis B virus DNA copy number",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1000,
                                        "unit": "copies/ml"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 200,
                                        "unit": "IU/ml"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "antibodies",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "RNA testing",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "13. Individuals allergic to the study drug;",
                "criterions": [
                    {
                        "exact_snippets": "Individuals allergic to the study drug",
                        "criterion": "allergy to study drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Individuals allergic to the study drug",
                        "criterion": "allergy to study drug",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}