{
    "info": {
        "nct_id": "NCT03940820",
        "official_title": "Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors",
        "inclusion_criteria": "1. Age 18 ~ 75 years old, male or female\n2. Life expectancy ≥ 6 months\n3. ECOG score: 0 - 3\n4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)\n5. Advanced solid tumor was diagnosed by pathological or clinical physicians\n6. Laboratory examination: white blood cell ≥ 3 x 10*9/L, blood platelet count ≥ 60 x 10*/L, hemoglobin ≥ 85g/L; lymphocyte count ≥ 15%, total bilirubin ≤ 100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level\n7. Signed informed consent\n8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Expected overall survival < 6 months\n2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months\n3. Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%\n4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.\n5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age 18 ~ 75 years old, male or 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": "male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "allowed_values",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Life expectancy ≥ 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy ≥ 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG score: 0 - 3",
            "criterions": [
                {
                    "exact_snippets": "ECOG score: 0 - 3",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)",
            "criterions": [
                {
                    "exact_snippets": "ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)",
                    "criterion": "ROBO1 expression",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "immuno-histochemistry (IHC)"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Advanced solid tumor was diagnosed by pathological or clinical physicians",
            "criterions": [
                {
                    "exact_snippets": "Advanced solid tumor was diagnosed",
                    "criterion": "advanced solid tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Laboratory examination: white blood cell ≥ 3 x 10*9/L, blood platelet count ≥ 60 x 10*/L, hemoglobin ≥ 85g/L; lymphocyte count ≥ 15%, total bilirubin ≤ 100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level",
            "criterions": [
                {
                    "exact_snippets": "white blood cell ≥ 3 x 10*9/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "x 10*9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "blood platelet count ≥ 60 x 10*/L",
                    "criterion": "blood platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "x 10*/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 85g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 85,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymphocyte count ≥ 15%",
                    "criterion": "lymphocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤ 100 mol/L",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "mol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST less than five times of the normal level",
                    "criterion": "ALT and AST levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "less than five times of the normal level"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine less than 1.5 times of the normal level",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "less than 1.5 times of the normal level"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to practice birth control",
                    "criterion": "birth control",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "after 2 weeks following the cell transfusion",
                    "criterion": "timing of birth control",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after 2 weeks following the cell transfusion"
                        }
                    ]
                }
            ]
        },
        {
            "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. Expected overall survival < 6 months",
            "criterions": [
                {
                    "exact_snippets": "Expected overall survival < 6 months",
                    "criterion": "overall survival",
                    "requirements": [
                        {
                            "requirement_type": "expected duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable coronary disease",
                    "criterion": "coronary disease",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "decompensated congestive heart failure (> Class II, NYHA)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "compensation status",
                            "expected_value": "decompensated"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "Class II, NYHA"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%",
            "criterions": [
                {
                    "exact_snippets": "Abnormal lung function: FEV (forced expiratory volume) < 30% prediction",
                    "criterion": "FEV (forced expiratory volume)",
                    "requirements": [
                        {
                            "requirement_type": "prediction",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "% prediction"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction",
                    "criterion": "DLCO (diffusing capacity of the lung for carbon monoxide)",
                    "requirements": [
                        {
                            "requirement_type": "prediction",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "% prediction"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "blood oxygen saturation < 90%",
                    "criterion": "blood oxygen saturation",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.",
            "criterions": [
                {
                    "exact_snippets": "nervous",
                    "criterion": "nervous diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "immune regulatory diseases",
                    "criterion": "immune regulatory diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metabolic diseases",
                    "criterion": "metabolic diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "infectious diseases",
                    "criterion": "infectious diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability and willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fail to comply with the test requirements",
                    "criterion": "compliance with test requirements",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}