{
    "info": {
        "nct_id": "NCT06715982",
        "official_title": "JAK Inhibitors for Solid Malignant Tumor Patients with Immune Checkpoint Inhibitors-related Dermatitis: a Open-lable, Single Arm, Phase II Trial",
        "inclusion_criteria": "* Patients receiving treatment with any of the Food and Drug Administration (FDA) approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination.\n\nPatients recommended to undergo skin biopsy due to a clinical diagnosis of ICI-induced dermatitis as part of routine and standard clinical care are eligible.\n\nMay have been treated with additional steroids or immunomodulators (one or more) prior to study entry (e.g. infliximab, mycophenolate mofetil, intravenous immunoglobulin), provided such immunomodulators are discontinued prior to first dose of study therapy.\n\nPatients must be age 18 or older. Patients diagnosed with solid malignant tumor. Eastern Cooperative Oncology Group (ECOG) performance status < 2. Measurable disease as per RECIST 1.1 Patients must be able to personally sign and date informed consent indicating that the patient has been informed of all pertinent aspects of the study are eligible.\n\nAdequate organ and marrow function as defined below:\n\nWhite blood cell (WBC) ≥ 2.0 ×109/L. Neutrophil (ANC) ≥ 1.5 ×109/L. Platelet (PLT) ≥ 75 ×109/L. Hemoglobin (Hgb) ≥ 8.0 g/dL. AST and ALT ≤ 3 x ULN in subjects without hepatic metastases; AST and ALT ≤ 5 x ULN in subjects with hepatic metastases, if AST/ALT elevation is NOT due to ICI-induced hepatitis.\n\nTotal bilirubin ≤ 2 x ULN not due to ICI-hepatitis (except subjects with Gilbert syndrome, where total bilirubin must be < 3.0 mg/dL).\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Patients taking antibiotics or who plan to begin taking antibiotics Known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of results Not recovered to non-dermatologic =< grade 1 toxicities related to any prior therapy Pregnant woman Patients with human immunodeficiency virus (HIV), hepatitis B, or C will be excluded from this study Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients receiving treatment with any of the Food and Drug Administration (FDA) approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving treatment with any of the Food and Drug Administration (FDA) approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination.",
                    "criterion": "treatment with FDA approved monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": [
                                "CTLA-4",
                                "PD-1",
                                "PD-L1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients recommended to undergo skin biopsy due to a clinical diagnosis of ICI-induced dermatitis as part of routine and standard clinical care are eligible.",
            "criterions": [
                {
                    "exact_snippets": "clinical diagnosis of ICI-induced dermatitis",
                    "criterion": "ICI-induced dermatitis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "May have been treated with additional steroids or immunomodulators (one or more) prior to study entry (e.g. infliximab, mycophenolate mofetil, intravenous immunoglobulin), provided such immunomodulators are discontinued prior to first dose of study therapy.",
            "criterions": [
                {
                    "exact_snippets": "treated with additional steroids or immunomodulators (one or more) prior to study entry",
                    "criterion": "prior treatment with steroids or immunomodulators",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "immunomodulators are discontinued prior to first dose of study therapy",
                    "criterion": "discontinuation of immunomodulators",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to first dose of study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients must be age 18 or older. Patients diagnosed with solid malignant tumor. Eastern Cooperative Oncology Group (ECOG) performance status < 2. Measurable disease as per RECIST 1.1 Patients must be able to personally sign and date informed consent indicating that the patient has been informed of all pertinent aspects of the study are eligible.",
            "criterions": [
                {
                    "exact_snippets": "age 18 or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosed with solid malignant tumor",
                    "criterion": "solid malignant tumor",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status < 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable disease as per RECIST 1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "able to personally sign and date informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability to sign and date",
                            "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": "White blood cell (WBC) ≥ 2.0 ×109/L. Neutrophil (ANC) ≥ 1.5 ×109/L. Platelet (PLT) ≥ 75 ×109/L. Hemoglobin (Hgb) ≥ 8.0 g/dL. AST and ALT ≤ 3 x ULN in subjects without hepatic metastases; AST and ALT ≤ 5 x ULN in subjects with hepatic metastases, if AST/ALT elevation is NOT due to ICI-induced hepatitis.",
            "criterions": [
                {
                    "exact_snippets": "White blood cell (WBC) ≥ 2.0 ×109/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Neutrophil (ANC) ≥ 1.5 ×109/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet (PLT) ≥ 75 ×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin (Hgb) ≥ 8.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 3 x ULN in subjects without hepatic metastases",
                    "criterion": "AST and ALT levels in subjects without hepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤ 5 x ULN in subjects with hepatic metastases, if AST/ALT elevation is NOT due to ICI-induced hepatitis",
                    "criterion": "AST and ALT levels in subjects with hepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Total bilirubin ≤ 2 x ULN not due to ICI-hepatitis (except subjects with Gilbert syndrome, where total bilirubin must be < 3.0 mg/dL).",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≤ 2 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not due to ICI-hepatitis",
                    "criterion": "ICI-hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "cause of elevated bilirubin",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except subjects with Gilbert syndrome",
                    "criterion": "Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin must be < 3.0 mg/dL",
                    "criterion": "total bilirubin in subjects with Gilbert syndrome",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients taking antibiotics or who plan to begin taking antibiotics Known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of results Not recovered to non-dermatologic =< grade 1 toxicities related to any prior therapy Pregnant woman Patients with human immunodeficiency virus (HIV), hepatitis B, or C will be excluded from this study Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)",
            "criterions": [
                {
                    "exact_snippets": "Patients taking antibiotics or who plan to begin taking antibiotics",
                    "criterion": "antibiotic use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis)",
                    "criterion": "chronic skin inflammation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Not recovered to non-dermatologic =< grade 1 toxicities related to any prior therapy",
                    "criterion": "non-dermatologic toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant woman",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with human immunodeficiency virus (HIV), hepatitis B, or C",
                    "criterion": "HIV, hepatitis B, or C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures",
                    "criterion": "other contraindicating conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}