{
    "info": {
        "nct_id": "NCT04183166",
        "official_title": "A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.",
        "inclusion_criteria": "1. Signed written informed consent\n2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx\n3. Female or male patients, aged at least 18 years\n4. Patients in Complete Response after treatment of their primary tumor.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n6. Adequate hematological, hepatic and renal functions\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.\n2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.\n3. Other active malignancy requiring concurrent systemic intervention.\n4. Patients with previous malignancies other than the target malignancy to be investigated in this trial\n5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)\n6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection\n7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL)\n8. Treatment with another investigational agent since the beginning of the screening period\n9. Uncontrolled intercurrent illness",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Signed written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Signed written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Signed written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "written",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Signed written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Signed written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "written",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx",
                "criterions": [
                    {
                        "exact_snippets": "Newly diagnosed",
                        "criterion": "diagnosis status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    },
                    {
                        "exact_snippets": "stage III or IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "amenable to surgery",
                        "criterion": "surgical eligibility",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous-cell carcinoma",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "squamous-cell carcinoma"
                        }
                    },
                    {
                        "exact_snippets": "oral cavity, oropharynx, hypopharynx or larynx",
                        "criterion": "cancer location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Newly diagnosed",
                                                "criterion": "diagnosis status",
                                                "requirement": {
                                                    "requirement_type": "status",
                                                    "expected_value": "newly diagnosed"
                                                }
                                            },
                                            {
                                                "exact_snippets": "stage III or IV",
                                                "criterion": "cancer stage",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": [
                                                        "III",
                                                        "IV"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "amenable to surgery",
                                        "criterion": "surgical eligibility",
                                        "requirement": {
                                            "requirement_type": "eligibility",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "squamous-cell carcinoma",
                                "criterion": "cancer type",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "squamous-cell carcinoma"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "oral cavity, oropharynx, hypopharynx or larynx",
                        "criterion": "cancer location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Female or male patients, aged at least 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Female or male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "female",
                                "male"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "aged at least 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Female or male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "female",
                                "male"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "aged at least 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Patients in Complete Response after treatment of their primary tumor.",
                "criterions": [
                    {
                        "exact_snippets": "Patients in Complete Response after treatment of their primary tumor",
                        "criterion": "complete response",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "after treatment of primary tumor"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients in Complete Response after treatment of their primary tumor",
                        "criterion": "complete response",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "after treatment of primary tumor"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Adequate hematological, hepatic and renal functions",
                "criterions": [
                    {
                        "exact_snippets": "Adequate hematological ... functions",
                        "criterion": "hematological functions",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic ... functions",
                        "criterion": "hepatic functions",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal functions",
                        "criterion": "renal functions",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate hematological ... functions",
                        "criterion": "hematological functions",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... hepatic ... functions",
                        "criterion": "hepatic functions",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Adequate ... renal functions",
                        "criterion": "renal functions",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.",
                "criterions": [
                    {
                        "exact_snippets": "carcinoma of the nasopharynx",
                        "criterion": "carcinoma of the nasopharynx",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell-carcinoma of unknown primary",
                        "criterion": "squamous cell-carcinoma of unknown primary",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma that originates from the skin",
                        "criterion": "squamous cell carcinoma originating from the skin",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma that originates from the ... salivary gland",
                        "criterion": "squamous cell carcinoma originating from the salivary gland",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell carcinoma that originates from the ... paranasal sinus",
                        "criterion": "squamous cell carcinoma originating from the paranasal sinus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "non-squamous histologies",
                        "criterion": "non-squamous histologies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "squamous cell carcinoma that originates from the skin",
                                "criterion": "squamous cell carcinoma originating from the skin",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "squamous cell carcinoma that originates from the ... salivary gland",
                                "criterion": "squamous cell carcinoma originating from the salivary gland",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "squamous cell carcinoma that originates from the ... paranasal sinus",
                                "criterion": "squamous cell carcinoma originating from the paranasal sinus",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "carcinoma of the nasopharynx",
                        "criterion": "carcinoma of the nasopharynx",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "squamous cell-carcinoma of unknown primary",
                        "criterion": "squamous cell-carcinoma of unknown primary",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "non-squamous histologies",
                        "criterion": "non-squamous histologies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.",
                "criterions": [
                    {
                        "exact_snippets": "Prior exposure to anti-cancer vaccines",
                        "criterion": "anti-cancer vaccines",
                        "requirement": {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies",
                        "criterion": "antibody targeting T-cell co-regulatory proteins",
                        "requirement": {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior exposure to anti-cancer vaccines",
                        "criterion": "anti-cancer vaccines",
                        "requirement": {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies",
                        "criterion": "antibody targeting T-cell co-regulatory proteins",
                        "requirement": {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Other active malignancy requiring concurrent systemic intervention.",
                "criterions": [
                    {
                        "exact_snippets": "Other active malignancy requiring concurrent systemic intervention.",
                        "criterion": "active malignancy",
                        "requirement": {
                            "requirement_type": "intervention",
                            "expected_value": "concurrent systemic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Other active malignancy requiring concurrent systemic intervention.",
                    "criterion": "active malignancy",
                    "requirement": {
                        "requirement_type": "intervention",
                        "expected_value": "concurrent systemic"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Patients with previous malignancies other than the target malignancy to be investigated in this trial",
                "criterions": [
                    {
                        "exact_snippets": "Patients with previous malignancies other than the target malignancy",
                        "criterion": "previous malignancies",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients with previous malignancies other than the target malignancy",
                        "criterion": "previous malignancies",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)",
                "criterions": [
                    {
                        "exact_snippets": "Known history of positive testing for Human Immunodeficiency Virus (HIV)",
                        "criterion": "Human Immunodeficiency Virus (HIV)",
                        "requirement": {
                            "requirement_type": "testing result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "known Acquired Immune Deficiency Syndrome (AIDS)",
                        "criterion": "Acquired Immune Deficiency Syndrome (AIDS)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known history of positive testing for Human Immunodeficiency Virus (HIV)",
                        "criterion": "Human Immunodeficiency Virus (HIV)",
                        "requirement": {
                            "requirement_type": "testing result",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "known Acquired Immune Deficiency Syndrome (AIDS)",
                        "criterion": "Acquired Immune Deficiency Syndrome (AIDS)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection",
                "criterions": [
                    {
                        "exact_snippets": "Clinical or laboratory history or evidence of Hepatitis C Virus (HCV)",
                        "criterion": "Hepatitis C Virus (HCV) infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Clinical or laboratory history or evidence of Hepatitis C Virus (HCV)",
                        "criterion": "Hepatitis C Virus (HCV) infection",
                        "requirement": {
                            "requirement_type": "infection status",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Clinical or laboratory history or evidence of ... Hepatitis B Virus (HBV)",
                        "criterion": "Hepatitis B Virus (HBV) infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Clinical or laboratory history or evidence of ... Hepatitis B Virus (HBV)",
                        "criterion": "Hepatitis B Virus (HBV) infection",
                        "requirement": {
                            "requirement_type": "infection status",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinical or laboratory history or evidence of Hepatitis C Virus (HCV)",
                                "criterion": "Hepatitis C Virus (HCV) infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Clinical or laboratory history or evidence of Hepatitis C Virus (HCV)",
                                "criterion": "Hepatitis C Virus (HCV) infection",
                                "requirement": {
                                    "requirement_type": "infection status",
                                    "expected_value": [
                                        "acute",
                                        "chronic"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinical or laboratory history or evidence of ... Hepatitis B Virus (HBV)",
                                "criterion": "Hepatitis B Virus (HBV) infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Clinical or laboratory history or evidence of ... Hepatitis B Virus (HBV)",
                                "criterion": "Hepatitis B Virus (HBV) infection",
                                "requirement": {
                                    "requirement_type": "infection status",
                                    "expected_value": [
                                        "acute",
                                        "chronic"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL)",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant ... pregnancy is defined as the state of a female after conception and until the termination of gestation",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "nursing (lactating) women",
                        "criterion": "nursing (lactating)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "confirmed by a positive hCG laboratory test (> 10 mIU/mL)",
                        "criterion": "hCG laboratory test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mIU/mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Pregnant ... pregnancy is defined as the state of a female after conception and until the termination of gestation",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "confirmed by a positive hCG laboratory test (> 10 mIU/mL)",
                                "criterion": "hCG laboratory test",
                                "requirement": {
                                    "requirement_type": "result",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "mIU/mL"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "nursing (lactating) women",
                        "criterion": "nursing (lactating)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Treatment with another investigational agent since the beginning of the screening period",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with another investigational agent since the beginning of the screening period",
                        "criterion": "treatment with another investigational agent",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "since the beginning of the screening period"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Treatment with another investigational agent since the beginning of the screening period",
                    "criterion": "treatment with another investigational agent",
                    "requirement": {
                        "requirement_type": "timeframe",
                        "expected_value": "since the beginning of the screening period"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Uncontrolled intercurrent illness",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness",
                        "criterion": "intercurrent illness",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirement": {
                        "requirement_type": "control status",
                        "expected_value": "uncontrolled"
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}