{
    "info": {
        "nct_id": "NCT05604560",
        "official_title": "A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer",
        "inclusion_criteria": "* Ability to understand and willingness to sign a written informed consent document.\n* Age ≥18 years.\n* Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas.\n* Tumor must be resectable.\n* Patient's acceptance to have a tumor biopsy.\n* ECOG performance status 0 or 1\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* For both Women and Men, must use acceptable form of birth control while on study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Have received any anti-pancreatic cancer therapy.\n* Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study.\n* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures\n* Subjects with active, known or suspected autoimmune disease that may relapse.\n* Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.\n* Active infection requiring systemic therapy.\n* Infection with HIV or hepatitis B or C at screening•\n* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Prior allogeneic stem cell transplantation or organ transplantation\n* Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.\n* Have received a live vaccine ≤ 28 days before first dose of study drug.\n* Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.\n* ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome.\n* Severe hypersensitivity reaction to any monoclonal antibody.\n* Concurrent participation in another therapeutic clinical study\n* Pregnant or breastfeeding",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ability to understand and willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed have histologically or cytologically proven adenocarcinoma of the pancreas.",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically proven",
                    "criterion": "proof method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the pancreas",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "adenocarcinoma of the pancreas"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor must be resectable.",
            "criterions": [
                {
                    "exact_snippets": "Tumor must be resectable.",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient's acceptance to have a tumor biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Patient's acceptance to have a tumor biopsy.",
                    "criterion": "tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "acceptance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ and marrow function",
                    "criterion": "organ and marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "defined by study-specified laboratory tests"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For both Women and Men, must use acceptable form of birth control while on study.",
            "criterions": [
                {
                    "exact_snippets": "Women and Men, must use acceptable form of birth control",
                    "criterion": "birth control usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Have received any anti-pancreatic cancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "received any anti-pancreatic cancer therapy",
                    "criterion": "anti-pancreatic cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have been diagnosed with another malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study.",
            "criterions": [
                {
                    "exact_snippets": "Have been diagnosed with another malignancy",
                    "criterion": "another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study",
                    "criterion": "interference with safety or efficacy assessment",
                    "requirements": [
                        {
                            "requirement_type": "potential to interfere",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures",
            "criterions": [
                {
                    "exact_snippets": "alcohol or drug dependence",
                    "criterion": "alcohol or drug dependence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of sufficient peripheral venous access",
                    "criterion": "peripheral venous access",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with active, known or suspected autoimmune disease that may relapse.",
            "criterions": [
                {
                    "exact_snippets": "active, known or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune disease that may relapse",
                    "criterion": "autoimmune disease relapse",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Systemic steroid therapy (> 10mg daily prednisone equivalent) or immunosuppressive therapy within 14 days of first dose of study drug administration.",
            "criterions": [
                {
                    "exact_snippets": "Systemic steroid therapy (> 10mg daily prednisone equivalent)",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "immunosuppressive therapy within 14 days of first dose of study drug administration",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy.",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.",
            "criterions": [
                {
                    "exact_snippets": "History of interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diseases including pulmonary fibrosis",
                    "criterion": "pulmonary fibrosis",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled diseases including ... acute lung diseases",
                    "criterion": "acute lung diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic stem cell transplantation or organ transplantation",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic stem cell transplantation",
                    "criterion": "allogeneic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... organ transplantation",
                    "criterion": "organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received a live vaccine ≤ 28 days before first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Have received a live vaccine ≤ 28 days before first dose of study drug.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of QT prolonging drugs within 2 weeks before the start of SX-682 dosing and for the length of the study.",
            "criterions": [
                {
                    "exact_snippets": "Use of QT prolonging drugs",
                    "criterion": "QT prolonging drugs",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECG demonstrating a QTc interval ≥ 470 msec or patients with congenital long QT syndrome.",
            "criterions": [
                {
                    "exact_snippets": "ECG demonstrating a QTc interval ≥ 470 msec",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe hypersensitivity reaction to any monoclonal antibody.",
            "criterions": [
                {
                    "exact_snippets": "Severe hypersensitivity reaction to any monoclonal antibody.",
                    "criterion": "hypersensitivity reaction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "cause",
                            "expected_value": "monoclonal antibody"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent participation in another therapeutic clinical study",
            "criterions": [
                {
                    "exact_snippets": "Concurrent participation in another therapeutic clinical study",
                    "criterion": "participation in another therapeutic clinical study",
                    "requirements": [
                        {
                            "requirement_type": "concurrent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Infection with HIV or hepatitis B or C at screening•",
            "criterions": [
                {
                    "exact_snippets": "Infection with HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, pulmonary embolism, uncontrolled hypertension, 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 including, but not limited to, uncontrolled infection",
                    "criterion": "uncontrolled infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... uncontrolled hypertension",
                    "criterion": "uncontrolled hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... metastatic cancer",
                    "criterion": "metastatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}