{
    "info": {
        "nct_id": "NCT05050760",
        "official_title": "An Exploratory Study of the Efficacy and Safety of DCF Regimen Combined With Camrelizumab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma(ESCC)",
        "inclusion_criteria": "1. Age 18-75 years old patients with esophageal cancer, male and female.\n2. A patient with esophageal squamous cell carcinoma diagnosed by pathology.\n3. Initial treatment, no previous surgery.\n4. Subjects were patients with resectable locally advanced ESCC(AJCC V8 TNM classification),tumor node metastasis classification(TNM)\n5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale.\n6. Expected survival ≥ 3 months.\n7. All patients should have measurable or evaluable target lesions.\n8. Able to eat more than a liquid diet; No preesophageal perforation signs; There was no distant metastasis and the operation was tolerated.\n9. Demonstrate adequate organ function.\n10. Male subjects whose partners are women of childbearing age should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study administration.\n11. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Patients who did not meet the inclusion criteria for pathological type and primary site.\n2. Known to be allergic to macromolecular protein preparations, or components of carilizumab, or to loplatin, docetaxa, sergiol, contrast agents and their preparations.\n3. Risk of esophageal perforation or presence of esophageal ulcers.\n4. There is evidence of distant organ metastasis.\n5. Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed.\n6. had other malignant tumors ever.\n7. History of severe lung or heart disease.\n8. Active infection or fever of unknown cause > 38.5℃ in the 2 weeks prior to randomization (fever due to tumor can be included in the study as determined by the investigator).\n9. Significant active infection is known, or the investigator determines the presence of significant blood, renal, metabolic, gastrointestinal, or endocrine dysfunction.\n10. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n11. Subjects requiring systematic treatment with corticosteroids (>10mg/ day of prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to the first study drug. In the absence of active autoimmune disease, inhaled or topical steroid use and adrenal corticosteroid replacement at a dose >10mg/ day of prednisone efficacy dose were permitted.\n12. Participants had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of the assay).\n13. Those who had received live vaccine within 3 months prior to treatment.\n14. In the midst of acute or chronic tuberculosis infection.\n15. Patients were enrolled in clinical trials of other antitumor drugs within 4 weeks.\n16. IV fluids cannot be administered.\n17. She has a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation.\n18. Have a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age 18-75 years old patients with esophageal cancer, male and female.",
            "criterions": [
                {
                    "exact_snippets": "Age 18-75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal cancer",
                    "criterion": "esophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male and female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. A patient with esophageal squamous cell carcinoma diagnosed by pathology.",
            "criterions": [
                {
                    "exact_snippets": "esophageal squamous cell carcinoma",
                    "criterion": "esophageal squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed by pathology",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "pathology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Initial treatment, no previous surgery.",
            "criterions": [
                {
                    "exact_snippets": "Initial treatment",
                    "criterion": "treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "initial"
                        }
                    ]
                },
                {
                    "exact_snippets": "no previous surgery",
                    "criterion": "surgery history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects were patients with resectable locally advanced ESCC(AJCC V8 TNM classification),tumor node metastasis classification(TNM)",
            "criterions": [
                {
                    "exact_snippets": "resectable",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "ESCC",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "ESCC"
                        }
                    ]
                },
                {
                    "exact_snippets": "AJCC V8 TNM classification",
                    "criterion": "classification system",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": "AJCC V8"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor node metastasis classification(TNM)",
                    "criterion": "classification system",
                    "requirements": [
                        {
                            "requirement_type": "system",
                            "expected_value": "TNM"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale.",
            "criterions": [
                {
                    "exact_snippets": "performance status of 0 or 1 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Expected survival ≥ 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival ≥ 3 months.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. All patients should have measurable or evaluable target lesions.",
            "criterions": [
                {
                    "exact_snippets": "measurable or evaluable target lesions",
                    "criterion": "target lesions",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "evaluability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Able to eat more than a liquid diet; No preesophageal perforation signs; There was no distant metastasis and the operation was tolerated.",
            "criterions": [
                {
                    "exact_snippets": "Able to eat more than a liquid diet",
                    "criterion": "dietary intake",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "more than a liquid diet"
                        }
                    ]
                },
                {
                    "exact_snippets": "No preesophageal perforation signs",
                    "criterion": "preesophageal perforation signs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "operation was tolerated",
                    "criterion": "operation tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Demonstrate adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Male subjects whose partners are women of childbearing age should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study administration.",
            "criterions": [
                {
                    "exact_snippets": "Male subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "partners are women of childbearing age",
                    "criterion": "partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "women of childbearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically sterilized",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to use an effective method of contraception during the study period and for 3 months after the last study administration",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study period and for 3 months after the last study administration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.",
            "criterions": [
                {
                    "exact_snippets": "voluntarily joined the study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "follow-up",
                    "criterion": "follow-up",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients who did not meet the inclusion criteria for pathological type and primary site.",
            "criterions": [
                {
                    "exact_snippets": "pathological type",
                    "criterion": "pathological type",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary site",
                    "criterion": "primary site",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Known to be allergic to macromolecular protein preparations, or components of carilizumab, or to loplatin, docetaxa, sergiol, contrast agents and their preparations.",
            "criterions": [
                {
                    "exact_snippets": "Known to be allergic to macromolecular protein preparations",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "macromolecular protein preparations"
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... components of carilizumab",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "components of carilizumab"
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... loplatin",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "loplatin"
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... docetaxa",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "docetaxa"
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... sergiol",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "sergiol"
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... contrast agents and their preparations",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "contrast agents and their preparations"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Risk of esophageal perforation or presence of esophageal ulcers.",
            "criterions": [
                {
                    "exact_snippets": "Risk of esophageal perforation",
                    "criterion": "esophageal perforation",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of esophageal ulcers",
                    "criterion": "esophageal ulcers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. There is evidence of distant organ metastasis.",
            "criterions": [
                {
                    "exact_snippets": "evidence of distant organ metastasis",
                    "criterion": "distant organ metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Surgical treatment (except biopsy), radiotherapy, chemotherapy, and molecular targeted therapy have been performed.",
            "criterions": [
                {
                    "exact_snippets": "Surgical treatment (except biopsy) ... have been performed.",
                    "criterion": "surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy ... have been performed.",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chemotherapy ... have been performed.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "molecular targeted therapy have been performed.",
                    "criterion": "molecular targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. had other malignant tumors ever.",
            "criterions": [
                {
                    "exact_snippets": "had other malignant tumors ever",
                    "criterion": "other malignant tumors",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of severe lung or heart disease.",
            "criterions": [
                {
                    "exact_snippets": "History of severe lung ... disease.",
                    "criterion": "lung disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of severe ... heart disease.",
                    "criterion": "heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Active infection or fever of unknown cause > 38.5℃ in the 2 weeks prior to randomization (fever due to tumor can be included in the study as determined by the investigator).",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "fever of unknown cause > 38.5℃ in the 2 weeks prior to randomization",
                    "criterion": "fever of unknown cause",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 38.5,
                                "unit": "℃"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "2 weeks prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Significant active infection is known, or the investigator determines the presence of significant blood, renal, metabolic, gastrointestinal, or endocrine dysfunction.",
            "criterions": [
                {
                    "exact_snippets": "Significant active infection is known",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "investigator determines the presence of significant blood ... dysfunction",
                    "criterion": "blood dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "investigator determines the presence of significant ... renal ... dysfunction",
                    "criterion": "renal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "investigator determines the presence of significant ... metabolic ... dysfunction",
                    "criterion": "metabolic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "investigator determines the presence of significant ... gastrointestinal ... dysfunction",
                    "criterion": "gastrointestinal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "investigator determines the presence of significant ... endocrine dysfunction",
                    "criterion": "endocrine dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.",
            "criterions": [
                {
                    "exact_snippets": "history of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "other acquired or congenital immunodeficiency diseases",
                    "criterion": "immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acquired",
                                "congenital"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Subjects requiring systematic treatment with corticosteroids (>10mg/ day of prednisone efficacy dose) or other immunosuppressive agents within 14 days prior to the first study drug. In the absence of active autoimmune disease, inhaled or topical steroid use and adrenal corticosteroid replacement at a dose >10mg/ day of prednisone efficacy dose were permitted.",
            "criterions": [
                {
                    "exact_snippets": "Subjects requiring systematic treatment with corticosteroids (>10mg/ day of prednisone efficacy dose)",
                    "criterion": "systematic corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day of prednisone efficacy dose"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive agents within 14 days prior to the first study drug",
                    "criterion": "immunosuppressive agents",
                    "requirements": [
                        {
                            "requirement_type": "use within 14 days",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inhaled or topical steroid use",
                    "criterion": "inhaled or topical steroid use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adrenal corticosteroid replacement at a dose >10mg/ day of prednisone efficacy dose",
                    "criterion": "adrenal corticosteroid replacement",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg/day of prednisone efficacy dose"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Participants had active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), and hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of the assay).",
            "criterions": [
                {
                    "exact_snippets": "active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL)",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2000,
                                        "unit": "IU/mL"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10000,
                                        "unit": "copies/mL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C (HCV antibody positive and HCV-RNA higher than the lower limit of the assay)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "HCV antibody",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "HCV-RNA level",
                            "expected_value": "higher than the lower limit of the assay"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Those who had received live vaccine within 3 months prior to treatment.",
            "criterions": [
                {
                    "exact_snippets": "received live vaccine within 3 months prior to treatment",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. In the midst of acute or chronic tuberculosis infection.",
            "criterions": [
                {
                    "exact_snippets": "acute or chronic tuberculosis infection",
                    "criterion": "tuberculosis infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients were enrolled in clinical trials of other antitumor drugs within 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patients were enrolled in clinical trials of other antitumor drugs within 4 weeks.",
                    "criterion": "enrollment in clinical trials of other antitumor drugs",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. IV fluids cannot be administered.",
            "criterions": [
                {
                    "exact_snippets": "IV fluids cannot be administered.",
                    "criterion": "IV fluids",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. She has a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation.",
            "criterions": [
                {
                    "exact_snippets": "history of gastrointestinal ulcer",
                    "criterion": "gastrointestinal ulcer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... perforation",
                    "criterion": "perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Have a history of gastrointestinal ulcer, gastrointestinal bleeding and perforation",
            "criterions": [
                {
                    "exact_snippets": "history of gastrointestinal ulcer",
                    "criterion": "gastrointestinal ulcer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... perforation",
                    "criterion": "perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}