{
    "info": {
        "nct_id": "NCT03355560",
        "official_title": "A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy",
        "inclusion_criteria": "* Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options\n* Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.\n* Able to provide archived biopsy or resected tissue.\n* Adequate performance status and labs.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who did not receive at least radiotherapy as prior definitive treatment.\n* Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.\n* Has nasopharyngeal or sinonasal carcinoma.\n* Has confirmed metastatic disease.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options",
            "criterions": [
                {
                    "exact_snippets": "Prior definitive therapy with radiation",
                    "criterion": "prior definitive therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior surgical resection",
                    "criterion": "prior surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior ... chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "salvage resection with curative intent",
                    "criterion": "salvage resection",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "no other curable options",
                    "criterion": "curable options",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.",
            "criterions": [
                {
                    "exact_snippets": "Pre-operative scans including chest imaging",
                    "criterion": "pre-operative chest imaging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "preferably PET/CT",
                    "criterion": "PET/CT scan",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CT neck w/contrast",
                    "criterion": "CT neck with contrast",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI neck is acceptable if contrast contraindicated",
                    "criterion": "MRI neck",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "contrast contraindicated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide archived biopsy or resected tissue.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide archived biopsy or resected tissue.",
                    "criterion": "archived biopsy or resected tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate performance status and labs.",
            "criterions": [
                {
                    "exact_snippets": "Adequate performance status",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... labs",
                    "criterion": "laboratory results",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who did not receive at least radiotherapy as prior definitive treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients who did not receive at least radiotherapy as prior definitive treatment.",
                    "criterion": "prior definitive treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "radiotherapy"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.",
            "criterions": [
                {
                    "exact_snippets": "gross measurable residual disease after surgery",
                    "criterion": "residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "underwent surgery for palliative purposes",
                    "criterion": "surgery purpose",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "palliative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has nasopharyngeal or sinonasal carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Has nasopharyngeal ... carcinoma.",
                    "criterion": "nasopharyngeal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has ... sinonasal carcinoma.",
                    "criterion": "sinonasal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has confirmed metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Has confirmed metastatic disease.",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}