{
    "info": {
        "nct_id": "NCT05058560",
        "official_title": "Tislelizumab in Addition to Bronchial Arterial Chemoembolization in Patients With Non-Small-Cell Lung Cancer -- A Single-arm Phase II Trial",
        "inclusion_criteria": "1. Patient age between 18 and 75\n2. Signed Informed Consent Form.\n3. Confirmed TNM stage is III-Ⅳ of NSCLC ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, Chemotherapy)；\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n5. Adequate hematologic and end-organ function.\n6. Expected life span > 3 months.\n7. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.\n2. Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).\n3. Harboring EGFR sensitizing mutation or ALK gene translocation\n4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.\n5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.\n6. Symptomatic central nervous system metastasis\n7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.\n8. Prior allogeneic stem cell transplantation or organ transplantation\n9. Active autoimmune diseases or history of autoimmune diseases that may relapse.\n10. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications\n11. Known to be hypersensitive to contrast agent;\n12. Pregnant or breastfeeding women;\n13. Other protocol defined Inclusion/Exclusion criteria may apply",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Patient age between 18 and 75",
            "criterions": [
                {
                    "exact_snippets": "Patient age between 18 and 75",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Signed Informed Consent Form.",
            "criterions": [
                {
                    "exact_snippets": "Signed Informed Consent Form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Confirmed TNM stage is III-Ⅳ of NSCLC ，and failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, Chemotherapy)；",
            "criterions": [
                {
                    "exact_snippets": "Confirmed TNM stage is III-Ⅳ of NSCLC",
                    "criterion": "TNM stage of NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "failed, refused or assessed ineligible to receive conventional treatments (surgery, chemoradiotherapy, Chemotherapy)",
                    "criterion": "eligibility for conventional treatments",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate hematologic and end-organ function.",
            "criterions": [
                {
                    "exact_snippets": "Adequate hematologic ... function.",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... end-organ function.",
                    "criterion": "end-organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Expected life span > 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Expected life span > 3 months",
                    "criterion": "expected life span",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Be able to provide fresh or archival tumor tissues for PD-L1 expression in tumor cells",
            "criterions": [
                {
                    "exact_snippets": "fresh or archival tumor tissues",
                    "criterion": "tumor tissues",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PD-L1 expression in tumor cells",
                    "criterion": "PD-L1 expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.",
            "criterions": [
                {
                    "exact_snippets": "Prior therapies of docetaxel",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "drug",
                            "expected_value": "docetaxel"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment targeting PD-1",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "PD-1"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment targeting ... PD-L1",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "PD-L1"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment targeting ... CTLA-4",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "target",
                            "expected_value": "CTLA-4"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE).",
            "criterions": [
                {
                    "exact_snippets": "Prior therapies of interventional therapy (I seeds implantation, Ablation, BACE)",
                    "criterion": "prior interventional therapies",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "I seeds implantation",
                                "Ablation",
                                "BACE"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Harboring EGFR sensitizing mutation or ALK gene translocation",
            "criterions": [
                {
                    "exact_snippets": "Harboring EGFR sensitizing mutation",
                    "criterion": "EGFR sensitizing mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK gene translocation",
                    "criterion": "ALK gene translocation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significantly impaired pulmonary function",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": "significantly impaired"
                        }
                    ]
                },
                {
                    "exact_snippets": "require supplemental oxygen at baseline",
                    "criterion": "supplemental oxygen requirement",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.",
            "criterions": [
                {
                    "exact_snippets": "uncontrollable pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable ... pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant ascites requiring interventional treatment",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "interventional treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Symptomatic central nervous system metastasis",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.",
            "criterions": [
                {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "active vaccination treatment",
                    "criterion": "vaccination treatment",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Active autoimmune diseases or history of autoimmune diseases that may relapse.",
            "criterions": [
                {
                    "exact_snippets": "Active autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of autoimmune diseases that may relapse",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "relapse potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications",
            "criterions": [
                {
                    "exact_snippets": "conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent)",
                    "criterion": "systemic treatment with corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone or equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions requiring systemic treatment with ... other immunosuppressive medications",
                    "criterion": "systemic treatment with immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Known to be hypersensitive to contrast agent;",
            "criterions": [
                {
                    "exact_snippets": "Known to be hypersensitive to contrast agent",
                    "criterion": "hypersensitivity to contrast agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Pregnant or breastfeeding women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Other protocol defined Inclusion/Exclusion criteria may apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol defined Inclusion/Exclusion criteria",
                    "criterion": "protocol defined criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "8. Prior allogeneic stem cell transplantation or organ transplantation",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic stem cell transplantation",
                    "criterion": "allogeneic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior ... organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}