{
    "info": {
        "nct_id": "NCT04985201",
        "official_title": "Clinical Study of Irinotecan With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy",
        "inclusion_criteria": "Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and be able to complete all test procedures.\n\nHistologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system).\n\nNo patients with resectable or radical radiotherapy lung cancer. Patient must have no Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) rearrangement, or ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement.\n\nPatient must be at least resistant to the first-line chemotherapy. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n\nPatients can tolerate chemotherapy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "Unclear diagnosis of SCLC. Resectable or radical radiotherapy SCLC. Contraindicated chemotherapy. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.\n\nPositive test result for human immunodeficiency virus (HIV). Positive test result for active tuberculosis. Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines.\n\nPregnant or lactating women. A history of psychotropic substance abuse, drug abuse, or alcoholism. Other factors assessed by the sponsors.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and be able to complete all test procedures.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be volunteered to participate",
                    "criterion": "volunteering",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must sign the informed Consent form (ICF)",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be willing to follow and be able to complete all test procedures",
                    "criterion": "test procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed ES-SCLC",
                    "criterion": "ES-SCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "per the Veterans Administration Lung Study Group [VALG] staging system",
                    "criterion": "staging system",
                    "requirements": [
                        {
                            "requirement_type": "system",
                            "expected_value": "Veterans Administration Lung Study Group [VALG]"
                        }
                    ]
                }
            ]
        },
        {
            "line": "No patients with resectable or radical radiotherapy lung cancer. Patient must have no Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) rearrangement, or ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement.",
            "criterions": [
                {
                    "exact_snippets": "resectable or radical radiotherapy lung cancer",
                    "criterion": "lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "not resectable",
                                "not radical radiotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no Epidermal Growth Factor Receptor (EGFR) mutation",
                    "criterion": "Epidermal Growth Factor Receptor (EGFR) mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no ... Anaplastic lymphoma kinase (ALK) rearrangement",
                    "criterion": "Anaplastic lymphoma kinase (ALK) rearrangement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no ... ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement",
                    "criterion": "ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patient must be at least resistant to the first-line chemotherapy. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.",
            "criterions": [
                {
                    "exact_snippets": "Patient must be at least resistant to the first-line chemotherapy.",
                    "criterion": "resistance to first-line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": "at least resistant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients can tolerate chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "tolerate chemotherapy",
                    "criterion": "chemotherapy tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "Unclear diagnosis of SCLC. Resectable or radical radiotherapy SCLC. Contraindicated chemotherapy. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Unclear diagnosis of SCLC.",
                    "criterion": "diagnosis of SCLC",
                    "requirements": [
                        {
                            "requirement_type": "clarity",
                            "expected_value": "unclear"
                        }
                    ]
                },
                {
                    "exact_snippets": "Resectable or radical radiotherapy SCLC.",
                    "criterion": "SCLC treatment option",
                    "requirements": [
                        {
                            "requirement_type": "treatment option",
                            "expected_value": [
                                "resectable",
                                "radical radiotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindicated chemotherapy.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Undergoing other active malignancies within 5 years or at the same time.",
                    "criterion": "other active malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 5 years or at the same time"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.",
                    "criterion": "localized curable tumors",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Positive test result for human immunodeficiency virus (HIV). Positive test result for active tuberculosis. Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines.",
            "criterions": [
                {
                    "exact_snippets": "Positive test result for human immunodeficiency virus (HIV).",
                    "criterion": "HIV test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive test result for active tuberculosis.",
                    "criterion": "active tuberculosis test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Live vaccine was administered within 28 days of initial administration.",
                    "criterion": "live vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines.",
                    "criterion": "seasonal influenza vaccine type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "inactivated viral",
                                "not live attenuated intranasal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pregnant or lactating women. A history of psychotropic substance abuse, drug abuse, or alcoholism. Other factors assessed by the sponsors.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating women.",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "pregnant",
                                "lactating"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "A history of psychotropic substance abuse, drug abuse, or alcoholism.",
                    "criterion": "substance abuse history",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": [
                                "psychotropic substance abuse",
                                "drug abuse",
                                "alcoholism"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Other factors assessed by the sponsors.",
                    "criterion": "other factors",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "assessed by the sponsors"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}