{
    "info": {
        "nct_id": "NCT04799431",
        "official_title": "A Pilot Study of a Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma",
        "inclusion_criteria": "* Age ≥18 years.\n* Have histologically or cytologically - proven cancer of the pancreas or colon.\n* Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).\n* Measurable disease as per RECIST 1.1.\n* Have sufficient and accessible tissue for NGS and immune-phenotyping.\n* Have not received any prior systemic therapy in the metastatic setting for PDA or CRC. Patients who have received adjuvant chemotherapy >12 months prior to the diagnosis of metastatic disease may be eligible.\n* ECOG performance status 0.\n* Life expectancy of greater than 6 months.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.\n* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.\n* Men must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Is a candidate for definitive surgical resection.\n* Is unwilling or unable to undergo standard of care therapy.\n* Known history or evidence of brain metastases and/or leptomeningeal spread.\n* Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).\n* Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.\n* Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n* Known history or concurrent interstitial lung disease.\n* Has a pulse oximetry < 95% on room air.\n* Requires the use of home oxygen.\n* Infection with HIV or hepatitis B or C.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Has been diagnosed with another cancer or myeloproliferative disorder within the past 5 year.\n* Has had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.\n* Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.\n* If at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.\n* Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.\n* Unwilling or unable to follow the study schedule for any reason.\n* Are pregnant or breastfeeding.\n* Any radiological or clinical pleural effusions or ascites.\n* Any peritoneal involvement by the tumor.\n* History of malignant small bowel obstruction.\n* On parenteral nutrition.\n* Any liver metastasis greater than 3 cm or greater than 5 liver metastases.\n* Known or suspected hypersensitivity to Hiltonol.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Age ≥18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years.",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "Age ≥18 years.",
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                        "requirement": {
                            "requirement_type": "value",
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                                "operator": ">=",
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                                "unit": "years"
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                ]
            }
        },
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                "line": "* Have histologically or cytologically - proven cancer of the pancreas or colon.",
                "criterions": [
                    {
                        "exact_snippets": "histologically or cytologically - proven cancer of the pancreas",
                        "criterion": "pancreatic cancer",
                        "requirement": {
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                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
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                        "criterion": "colon cancer",
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                            "requirement_type": "diagnosis method",
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                                "histologically",
                                "cytologically"
                            ]
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                    }
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                                        "cytologically"
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        },
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                "line": "* Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).",
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                    },
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                        "criterion": "accessible lesion",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
                    {
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                        "requirement": {
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                            "expected_value": true
                        }
                    }
                ]
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                        "and_criteria": [
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                                    "expected_value": true
                                }
                            },
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                                "criterion": "patient's acceptance",
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                            {
                                "exact_snippets": "accessible lesion at baseline and on treatment",
                                "criterion": "accessible lesion",
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                                    "requirement_type": "accessibility",
                                    "expected_value": true
                                }
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                            "criterion": "accessible lesion",
                            "requirement": {
                                "requirement_type": "accessibility",
                                "expected_value": true
                            }
                        },
                        "then_criteria": {
                            "exact_snippets": "if the lesion can be biopsied with acceptable clinical risk",
                            "criterion": "biopsy of lesion",
                            "requirement": {
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                                "expected_value": true
                            }
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Measurable disease as per RECIST 1.1.",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease as per RECIST 1.1.",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
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                        "exact_snippets": "Measurable disease as per RECIST 1.1.",
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                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have sufficient and accessible tissue for NGS and immune-phenotyping.",
                "criterions": [
                    {
                        "exact_snippets": "sufficient and accessible tissue for NGS",
                        "criterion": "tissue for NGS",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
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                            "expected_value": true
                        }
                    },
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                        "criterion": "tissue for immune-phenotyping",
                        "requirement": {
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                            "expected_value": true
                        }
                    },
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                        "exact_snippets": "sufficient and accessible tissue for ... immune-phenotyping",
                        "criterion": "tissue for immune-phenotyping",
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                            "expected_value": true
                        }
                    }
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                        "and_criteria": [
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                                "exact_snippets": "sufficient and accessible tissue for NGS",
                                "criterion": "tissue for NGS",
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                                    "expected_value": true
                                }
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                                "exact_snippets": "sufficient and accessible tissue for NGS",
                                "criterion": "tissue for NGS",
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                                    "expected_value": true
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                        "and_criteria": [
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                                "exact_snippets": "sufficient and accessible tissue for ... immune-phenotyping",
                                "criterion": "tissue for immune-phenotyping",
                                "requirement": {
                                    "requirement_type": "sufficiency",
                                    "expected_value": true
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                                "exact_snippets": "sufficient and accessible tissue for ... immune-phenotyping",
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                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Have not received any prior systemic therapy in the metastatic setting for PDA or CRC. Patients who have received adjuvant chemotherapy >12 months prior to the diagnosis of metastatic disease may be eligible.",
                "criterions": [
                    {
                        "exact_snippets": "Have not received any prior systemic therapy in the metastatic setting for PDA or CRC.",
                        "criterion": "prior systemic therapy in the metastatic setting for PDA or CRC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients who have received adjuvant chemotherapy >12 months prior to the diagnosis of metastatic disease may be eligible.",
                        "criterion": "adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
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                    "requirement": {
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                        "expected_value": false
                    }
                },
                "then_criteria": null,
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                            "unit": "months"
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        },
        {
            "identified_line": {
                "line": "* ECOG performance status 0.",
                "criterions": [
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                        "exact_snippets": "ECOG performance status 0",
                        "criterion": "ECOG performance status",
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                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    }
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                        "criterion": "ECOG performance status",
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                        }
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                ]
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        {
            "identified_line": {
                "line": "* Life expectancy of greater than 6 months.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy of greater than 6 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
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                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
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                        "exact_snippets": "Life expectancy of greater than 6 months.",
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                                "operator": ">",
                                "value": 6,
                                "unit": "months"
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            }
        },
        {
            "identified_line": {
                "line": "* Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ and marrow function",
                        "criterion": "organ and marrow function",
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                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
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                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.",
                "criterions": [
                    {
                        "exact_snippets": "Woman of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "woman of childbearing potential"
                        }
                    },
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                        "criterion": "pregnancy test",
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                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "follow contraceptive guidelines as defined per protocol",
                        "criterion": "contraceptive guidelines",
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                                "expected_value": "woman of childbearing potential"
                            }
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                                    "exact_snippets": "must have a negative pregnancy test",
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                                    }
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                                    "exact_snippets": "follow contraceptive guidelines as defined per protocol",
                                    "criterion": "contraceptive guidelines",
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                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Men must use acceptable form of birth control while on study.",
                "criterions": [
                    {
                        "exact_snippets": "Men must use acceptable form of birth control",
                        "criterion": "birth control usage",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
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                        "exact_snippets": "Men must use acceptable form of birth control",
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                        }
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                ]
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        },
        {
            "identified_line": {
                "line": "* Ability to understand and willingness to sign a written informed consent document.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
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                        "exact_snippets": "willingness to sign a written informed consent document",
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                            "expected_value": true
                        }
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                        "exact_snippets": "willingness to sign a written informed consent document",
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                        }
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            "identified_line": {
                "line": "Healthy volunteers allowed",
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                        "exact_snippets": "Healthy volunteers allowed",
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                        "exact_snippets": "Healthy volunteers allowed",
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        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
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                    {
                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
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                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
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                        "exact_snippets": "minimum age of 18 Years",
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                            "requirement_type": "minimum",
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                                "operator": ">=",
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                                "unit": "Years"
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                    }
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            }
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    ],
    "exclusion_lines": [
        {
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                "line": "* Is a candidate for definitive surgical resection.",
                "criterions": [
                    {
                        "exact_snippets": "Is a candidate for definitive surgical resection.",
                        "criterion": "definitive surgical resection candidacy",
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                                "exact_snippets": "Known history or evidence of ... leptomeningeal spread",
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                "line": "* Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).",
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                        "exact_snippets": "Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.)",
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        {
            "identified_line": {
                "line": "* Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Receiving active immunosuppressive agents",
                        "criterion": "active immunosuppressive agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic use of systemic corticosteroids within 14 days of vaccine treatment",
                        "criterion": "chronic use of systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days of vaccine treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Receiving active immunosuppressive agents",
                        "criterion": "active immunosuppressive agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic use of systemic corticosteroids within 14 days of vaccine treatment",
                        "criterion": "chronic use of systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days of vaccine treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.",
                "criterions": [
                    {
                        "exact_snippets": "active autoimmune disease that has required systemic treatment in the past 5 years",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "systemic treatment in the past 5 years"
                        }
                    },
                    {
                        "exact_snippets": "documented history of clinically severe autoimmune disease",
                        "criterion": "clinically severe autoimmune disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": "documented"
                        }
                    },
                    {
                        "exact_snippets": "syndrome that requires systemic steroids or immunosuppressive agents",
                        "criterion": "syndrome",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": [
                                "systemic steroids",
                                "immunosuppressive agents"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "active autoimmune disease that has required systemic treatment in the past 5 years",
                                "criterion": "active autoimmune disease",
                                "requirement": {
                                    "requirement_type": "treatment history",
                                    "expected_value": "systemic treatment in the past 5 years"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "documented history of clinically severe autoimmune disease",
                                "criterion": "clinically severe autoimmune disease",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": "documented"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "syndrome that requires systemic steroids or immunosuppressive agents",
                                "criterion": "syndrome",
                                "requirement": {
                                    "requirement_type": "treatment requirement",
                                    "expected_value": [
                                        "systemic steroids",
                                        "immunosuppressive agents"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known history or concurrent interstitial lung disease.",
                "criterions": [
                    {
                        "exact_snippets": "Known history or concurrent interstitial lung disease",
                        "criterion": "interstitial lung disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known history or concurrent interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has a pulse oximetry < 95% on room air.",
                "criterions": [
                    {
                        "exact_snippets": "pulse oximetry < 95%",
                        "criterion": "pulse oximetry",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 95,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "pulse oximetry < 95%",
                        "criterion": "pulse oximetry",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "on room air"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "pulse oximetry < 95%",
                        "criterion": "pulse oximetry",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 95,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "pulse oximetry < 95%",
                        "criterion": "pulse oximetry",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "on room air"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Requires the use of home oxygen.",
                "criterions": [
                    {
                        "exact_snippets": "Requires the use of home oxygen.",
                        "criterion": "home oxygen use",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Requires the use of home oxygen.",
                    "criterion": "home oxygen use",
                    "requirement": {
                        "requirement_type": "necessity",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... uncontrolled infection",
                        "criterion": "uncontrolled infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                        "criterion": "symptomatic congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... metastatic cancer",
                        "criterion": "metastatic cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... uncontrolled infection",
                                "criterion": "uncontrolled infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                                "criterion": "symptomatic congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... metastatic cancer",
                                "criterion": "metastatic cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                                "criterion": "psychiatric illness/social situations",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": "limit compliance with study requirements"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has been diagnosed with another cancer or myeloproliferative disorder within the past 5 year.",
                "criterions": [
                    {
                        "exact_snippets": "Has been diagnosed with another cancer",
                        "criterion": "diagnosis of another cancer",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Has been diagnosed with ... myeloproliferative disorder",
                        "criterion": "diagnosis of myeloproliferative disorder",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has been diagnosed with another cancer",
                                "criterion": "diagnosis of another cancer",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "year"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Has been diagnosed with ... myeloproliferative disorder",
                                "criterion": "diagnosis of myeloproliferative disorder",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "year"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.",
                "criterions": [
                    {
                        "exact_snippets": "Has had surgery within 28 days of dosing of investigational agent",
                        "criterion": "recent surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement",
                        "criterion": "type of surgery",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "minor procedures",
                                "celiac plexus block",
                                "biliary stent placement"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Has had surgery within 28 days of dosing of investigational agent",
                            "criterion": "recent surgery",
                            "requirement": {
                                "requirement_type": "time since surgery",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 28,
                                    "unit": "days"
                                }
                            }
                        },
                        {
                            "exact_snippets": "excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement",
                            "criterion": "type of surgery",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": [
                                    "minor procedures",
                                    "celiac plexus block",
                                    "biliary stent placement"
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.",
                        "criterion": "non-oncology live vaccine therapy",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.",
                    "criterion": "non-oncology live vaccine therapy",
                    "requirement": {
                        "requirement_type": "time since administration",
                        "expected_value": {
                            "operator": "<=",
                            "value": 28,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* If at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.",
                "criterions": [
                    {
                        "exact_snippets": "a regular user (including \"recreational use\") of any illicit drugs",
                        "criterion": "illicit drug use",
                        "requirement": {
                            "requirement_type": "frequency",
                            "expected_value": "regular use"
                        }
                    },
                    {
                        "exact_snippets": "other substance abuse (including alcohol)",
                        "criterion": "substance abuse",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "a regular user (including \"recreational use\") of any illicit drugs",
                                "criterion": "illicit drug use",
                                "requirement": {
                                    "requirement_type": "frequency",
                                    "expected_value": "regular use"
                                }
                            },
                            {
                                "exact_snippets": "other substance abuse (including alcohol)",
                                "criterion": "substance abuse",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "could potentially interfere with adherence to study procedures or requirements",
                        "criterion": "interference with study adherence",
                        "requirement": {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Any other sound medical ... reason",
                        "criterion": "medical reason",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": "as determined by the Investigator"
                        }
                    },
                    {
                        "exact_snippets": "Any other sound ... psychiatric ... reason",
                        "criterion": "psychiatric reason",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": "as determined by the Investigator"
                        }
                    },
                    {
                        "exact_snippets": "Any other sound ... social reason",
                        "criterion": "social reason",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": "as determined by the Investigator"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other sound medical ... reason",
                                "criterion": "medical reason",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": "as determined by the Investigator"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other sound ... psychiatric ... reason",
                                "criterion": "psychiatric reason",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": "as determined by the Investigator"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any other sound ... social reason",
                                "criterion": "social reason",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": "as determined by the Investigator"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Unwilling or unable to follow the study schedule for any reason.",
                "criterions": [
                    {
                        "exact_snippets": "Unwilling or unable to follow the study schedule",
                        "criterion": "ability to follow study schedule",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Unwilling or unable to follow the study schedule",
                    "criterion": "ability to follow study schedule",
                    "requirement": {
                        "requirement_type": "ability",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Are pregnant or breastfeeding.",
                "criterions": [
                    {
                        "exact_snippets": "Are pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Are pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any radiological or clinical pleural effusions or ascites.",
                "criterions": [
                    {
                        "exact_snippets": "radiological or clinical pleural effusions",
                        "criterion": "pleural effusions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiological or clinical ... ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "radiological or clinical pleural effusions",
                        "criterion": "pleural effusions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiological or clinical ... ascites",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any peritoneal involvement by the tumor.",
                "criterions": [
                    {
                        "exact_snippets": "peritoneal involvement by the tumor",
                        "criterion": "peritoneal involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "peritoneal involvement by the tumor",
                    "criterion": "peritoneal involvement",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* History of malignant small bowel obstruction.",
                "criterions": [
                    {
                        "exact_snippets": "History of malignant small bowel obstruction",
                        "criterion": "malignant small bowel obstruction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of malignant small bowel obstruction",
                    "criterion": "malignant small bowel obstruction",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* On parenteral nutrition.",
                "criterions": [
                    {
                        "exact_snippets": "On parenteral nutrition.",
                        "criterion": "parenteral nutrition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "On parenteral nutrition.",
                    "criterion": "parenteral nutrition",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any liver metastasis greater than 3 cm or greater than 5 liver metastases.",
                "criterions": [
                    {
                        "exact_snippets": "liver metastasis greater than 3 cm",
                        "criterion": "liver metastasis size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "greater than 5 liver metastases",
                        "criterion": "number of liver metastases",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "liver metastasis greater than 3 cm",
                        "criterion": "liver metastasis size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "greater than 5 liver metastases",
                        "criterion": "number of liver metastases",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Known or suspected hypersensitivity to Hiltonol.",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected hypersensitivity to Hiltonol.",
                        "criterion": "hypersensitivity to Hiltonol",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known or suspected hypersensitivity to Hiltonol.",
                        "criterion": "hypersensitivity to Hiltonol",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Infection with HIV or hepatitis B or C.",
                "criterions": [
                    {
                        "exact_snippets": "Infection with HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis B",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis C",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Infection with HIV",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis B",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatitis C",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}