{
    "info": {
        "nct_id": "NCT03692520",
        "official_title": "Recombinant Anti-EGFR Monoclonal Antibody（SCT200）in Patients With Advanced Solid Tumors or Lymphoma : A Phase Ⅰb, Open-label, Multicenter Study.",
        "inclusion_criteria": "* Able to provide written informed consent and can understand and comply with the requirements of the study;\n* Males or females. Aged 18 to 75 years old;\n* Life expectancy of longer than 3 months ( clinical assessment);\n* With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* Histological or cytological diagnosis of advanced solid tumors(gastric/gastroesophageal junction cancer, hepatocellular carcinoma,pancreatic cancer,gallbladder cancer/bile duct cancer，renal cell carcinoma，ovarian cancer，other advanced solid tumor)\n* Advanced solid tumor or lymphoma wuth failure of standard treatment;\n* According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed;\n* Adequate organ and marrow function as defined below:\n\nAbsolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;\n* Patients with active central nervous system metastasis or a history of central nervous system metastasis;(If the subject has been suspected with central nervous system metastasis,imaging examination confirmation must be performed within 28 days to exclude central nervous system metastasis;\n* Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time at least 28 days,the subject will be allowed to use it.) Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy.\n* Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer, carcinoma in situ of cervix, or prostatic intraepithelial neoplasia;\n* Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;\n* Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);\n* Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.\n* Prior to the first dose of study drug, patients received major surgery requiring general anesthesia has been completed less than 4 weeks; surgery requiring local anesthesia/epidural anesthesia has been completed less than 72 hours; skin biopsy requiring local anesthesia has been completed less than 1 hour.\n* Patients treated with EPO, G-CSF or GM-CSF.\n* Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia);\n* Patients occurred myocardial infarction within 6 months.\n* Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .\n* Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);\n* Patients with medical or psychiatric condition or laboratory abnormality may interfere with the interpretation of study results;\n* Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;\n* Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and for at least 6 months after your last dose of SCT200;\n* Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting HIV infection, there is no need to detect);\n* Patients with uncontrolled active infections within 2 weeks before enrollment (except urinary tract infection or upper respiratory tract infection);\n* Patients have alcohol or drug addiction;\n* Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Able to provide written informed consent and can understand and comply with the requirements of the study;",
            "criterions": [
                {
                    "exact_snippets": "Able to provide written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can understand and comply with the requirements of the study",
                    "criterion": "compliance with study requirements",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males or females. Aged 18 to 75 years old;",
            "criterions": [
                {
                    "exact_snippets": "Males or females.",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Aged 18 to 75 years old;",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of longer than 3 months ( clinical assessment);",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of longer than 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological or cytological diagnosis of advanced solid tumors(gastric/gastroesophageal junction cancer, hepatocellular carcinoma,pancreatic cancer,gallbladder cancer/bile duct cancer，renal cell carcinoma，ovarian cancer，other advanced solid tumor)",
            "criterions": [
                {
                    "exact_snippets": "Histological or cytological diagnosis of advanced solid tumors",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced solid tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "specific types",
                            "expected_value": [
                                "gastric/gastroesophageal junction cancer",
                                "hepatocellular carcinoma",
                                "pancreatic cancer",
                                "gallbladder cancer/bile duct cancer",
                                "renal cell carcinoma",
                                "ovarian cancer",
                                "other advanced solid tumor"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Advanced solid tumor or lymphoma wuth failure of standard treatment;",
            "criterions": [
                {
                    "exact_snippets": "Advanced solid tumor or lymphoma",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "advanced solid tumor",
                                "lymphoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failure of standard treatment",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failure of standard treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed;",
            "criterions": [
                {
                    "exact_snippets": "patients must have at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "that can be accurately assessed",
                    "criterion": "lesion assessment accuracy",
                    "requirements": [
                        {
                            "requirement_type": "accuracy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and marrow function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ and marrow function",
                    "criterion": "organ and marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×l09/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets greater than/equal to 75×109/L",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin greater than/equal to 80g/L",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases",
                    "criterion": "aspartate aminotransferase (AST)/alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "times ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "within institutional limit of normal (ULN)"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine less than/equal to 1.5 times ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Electrolyte: magnesium greater than/equal to normal",
                    "criterion": "electrolyte: magnesium",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "greater than/equal to normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;",
            "criterions": [
                {
                    "exact_snippets": "allergic to analogue of SCT200",
                    "criterion": "allergy to analogue of SCT200",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... its inactive ingredients",
                    "criterion": "allergy to inactive ingredients of SCT200",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active central nervous system metastasis or a history of central nervous system metastasis;(If the subject has been suspected with central nervous system metastasis,imaging examination confirmation must be performed within 28 days to exclude central nervous system metastasis;",
            "criterions": [
                {
                    "exact_snippets": "Patients with active central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging examination confirmation must be performed within 28 days",
                    "criterion": "imaging examination for central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time at least 28 days,the subject will be allowed to use it.) Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy.",
            "criterions": [
                {
                    "exact_snippets": "Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study.",
                    "criterion": "bisphosphonate or denosumab treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time at least 28 days",
                    "criterion": "stable bisphosphonate or denosumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "stability duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer, carcinoma in situ of cervix, or prostatic intraepithelial neoplasia;",
            "criterions": [
                {
                    "exact_snippets": "Patients with other primary malignancies",
                    "criterion": "other primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except cured of basal cell carcinoma skin cancer",
                    "criterion": "cured basal cell carcinoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... carcinoma in situ of cervix",
                    "criterion": "carcinoma in situ of cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... prostatic intraepithelial neoplasia",
                    "criterion": "prostatic intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;",
            "criterions": [
                {
                    "exact_snippets": "Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody",
                    "criterion": "EGFR target treatment",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.",
            "criterions": [
                {
                    "exact_snippets": "Patients are currently enrolled in other research devices",
                    "criterion": "enrollment in other research devices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients are currently enrolled in ... research drugs",
                    "criterion": "enrollment in other research drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "less than 4 weeks from other research drugs or devices",
                    "criterion": "time since last research drug or device",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior to the first dose of study drug, patients received major surgery requiring general anesthesia has been completed less than 4 weeks; surgery requiring local anesthesia/epidural anesthesia has been completed less than 72 hours; skin biopsy requiring local anesthesia has been completed less than 1 hour.",
            "criterions": [
                {
                    "exact_snippets": "major surgery requiring general anesthesia has been completed less than 4 weeks",
                    "criterion": "major surgery with general anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "surgery requiring local anesthesia/epidural anesthesia has been completed less than 72 hours",
                    "criterion": "surgery with local/epidural anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "skin biopsy requiring local anesthesia has been completed less than 1 hour",
                    "criterion": "skin biopsy with local anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "hour"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients treated with EPO, G-CSF or GM-CSF.",
            "criterions": [
                {
                    "exact_snippets": "Patients treated with EPO",
                    "criterion": "EPO treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients treated with ... G-CSF",
                    "criterion": "G-CSF treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients treated with ... GM-CSF",
                    "criterion": "GM-CSF treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia);",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiovascular disease (defined as unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant cardiovascular disease ... symptomatic congestive heart failure (NYHA, greater than II)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant cardiovascular disease ... uncontrollable severe arrhythmia",
                    "criterion": "severe arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "controllability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients occurred myocardial infarction within 6 months.",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .",
            "criterions": [
                {
                    "exact_snippets": "Patients who have interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "interstitial pneumonia",
                    "criterion": "interstitial pneumonia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CT or MRI reminder ILD",
                    "criterion": "CT or MRI reminder ILD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);",
            "criterions": [
                {
                    "exact_snippets": "clinical symptoms",
                    "criterion": "clinical symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required clinical intervention",
                    "criterion": "clinical intervention",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable time less than 4 weeks of serous cavity effusion",
                    "criterion": "stable time of serous cavity effusion",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with medical or psychiatric condition or laboratory abnormality may interfere with the interpretation of study results;",
            "criterions": [
                {
                    "exact_snippets": "medical or psychiatric condition",
                    "criterion": "medical or psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who planned to be pregnant within 6 months of treatment",
                    "criterion": "pregnancy plans",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 6 months of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and for at least 6 months after your last dose of SCT200;",
            "criterions": [
                {
                    "exact_snippets": "Patients who were not willing to accept effective contraceptive measures",
                    "criterion": "willingness to accept effective contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(including male or female subjects)",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "during treatment and for at least 6 months after your last dose of SCT200",
                    "criterion": "duration of contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and for at least 6 months after last dose of SCT200"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting HIV infection, there is no need to detect);",
            "criterions": [
                {
                    "exact_snippets": "active hepatitis B",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active hepatitis C",
                    "criterion": "active hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml",
                    "criterion": "hepatitis B history with HBV DNA level",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "HBV DNA level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 104,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 2000,
                                        "unit": "IU/ml"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV RNA≥15IU/ml",
                    "criterion": "HCV RNA level",
                    "requirements": [
                        {
                            "requirement_type": "HCV RNA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "IU/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV antibody positive",
                    "criterion": "HIV antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled active infections within 2 weeks before enrollment (except urinary tract infection or upper respiratory tract infection);",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled active infections within 2 weeks before enrollment",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks before enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "except urinary tract infection or upper respiratory tract infection",
                    "criterion": "infection type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "urinary tract infection",
                                "upper respiratory tract infection"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients have alcohol or drug addiction;",
            "criterions": [
                {
                    "exact_snippets": "alcohol or drug addiction",
                    "criterion": "alcohol addiction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alcohol or drug addiction",
                    "criterion": "drug addiction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures.",
            "criterions": [
                {
                    "exact_snippets": "considered unsuitable for participating in this study",
                    "criterion": "suitability for study participation",
                    "requirements": [
                        {
                            "requirement_type": "discretion of the investigator",
                            "expected_value": "suitable"
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to comply with study and/or follow-up procedures",
                    "criterion": "ability to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);",
            "criterions": [
                {
                    "exact_snippets": "Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs",
                    "criterion": "recent anti-tumor or research drug treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy (except alopecia or neurotoxicity grade 2 or less)",
                    "criterion": "adverse reaction to previous anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "alopecia",
                                "neurotoxicity grade 2 or less"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}