{
    "info": {
        "nct_id": "NCT03983057",
        "official_title": "Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial",
        "inclusion_criteria": "* Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).\n* No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.\n* Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).\n* ECOG score 0 or 1.\n* Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.\n* ALT and AST are less than 2 x ULN.\n* If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.\n* Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).\n* Signed informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma\n* History of participation of other clinical trails within 4 weeks\n* History of immunotherapy within 4 weeks\n* History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks\n* Tumor is a local recurrent lesion.\n* Imaging confirmed severe portal hypertension / cavernous transformation.\n* Ascites\n* Gastric outlet obstruction\n* Respiratory failure requires supplementation of oxygen.\n* Immune deficiency syndrome, such as active tuberculosis and HIV infection.\n* Hematological precancerous diseases, such as myelodysplastic syndromes.\n* Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.\n* Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings\n* Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)\n* Preexisting neuropathy > 1 (NCI CTCAE).\n* Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.\n* Severe serious wounds, ulcers or fractures.\n* Confirmed coagulant disease.\n* Clinical evaluation is unacceptable.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).",
            "criterions": [
                {
                    "exact_snippets": "Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC)",
                    "criterion": "pancreatic ductal adenocarcinoma (PDAC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.",
            "criterions": [
                {
                    "exact_snippets": "No evidence of distant metastasis (such as liver, peritoneum, lung)",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "evaluated by abdominal contrast-enhanced CT, MRI, and chest CT",
                    "criterion": "imaging evaluation methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "abdominal contrast-enhanced CT",
                                "MRI",
                                "chest CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "PET/CT or other imaging examinations would be used if necessary",
                    "criterion": "additional imaging methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "PET/CT",
                                "other imaging examinations"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).",
            "criterions": [
                {
                    "exact_snippets": "definitive borderline resectable or locally advanced tumors",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": [
                                "borderline resectable",
                                "locally advanced"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "resectability judgment is based on CT enhanced scan or magnetic resonance imaging",
                    "criterion": "imaging modality for resectability judgment",
                    "requirements": [
                        {
                            "requirement_type": "modality",
                            "expected_value": [
                                "CT enhanced scan",
                                "magnetic resonance imaging"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG score 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG score 0 or 1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine level is normal",
                    "criterion": "serum creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "serum total bilirubin level is less than 1.5 x ULN",
                    "criterion": "serum total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ALT and AST are less than 2 x ULN.",
            "criterions": [
                {
                    "exact_snippets": "ALT ... less than 2 x ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ... less than 2 x ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "biliary obstruction is observed",
                    "criterion": "biliary obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).",
            "criterions": [
                {
                    "exact_snippets": "Leukocyte count (> 3.5 x 10^6 /mL)",
                    "criterion": "leukocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.5,
                                "unit": "x 10^6 /mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil count (> 1.5 x 10^6 /mL)",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x 10^6 /mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count (> 80 x 10^6 /mL)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 80,
                                "unit": "x 10^6 /mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin (> 9 g/dL)",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma",
            "criterions": [
                {
                    "exact_snippets": "History of malignance treatment in the past",
                    "criterion": "history of malignance treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding basal and cutaneous squamous cell carcinoma",
                    "criterion": "basal and cutaneous squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding ... papillary thyroid carcinoma",
                    "criterion": "papillary thyroid carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of participation of other clinical trails within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "History of participation of other clinical trails within 4 weeks",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of immunotherapy within 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "History of immunotherapy within 4 weeks",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks",
            "criterions": [
                {
                    "exact_snippets": "History of receiving chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "History of receiving ... molecular target therapy",
                    "criterion": "molecular target therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor is a local recurrent lesion.",
            "criterions": [
                {
                    "exact_snippets": "Tumor is a local recurrent lesion.",
                    "criterion": "tumor",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": "local recurrent lesion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Imaging confirmed severe portal hypertension / cavernous transformation.",
            "criterions": [
                {
                    "exact_snippets": "Imaging confirmed severe portal hypertension",
                    "criterion": "portal hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "imaging"
                        }
                    ]
                },
                {
                    "exact_snippets": "Imaging confirmed ... cavernous transformation",
                    "criterion": "cavernous transformation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "imaging"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ascites",
            "criterions": [
                {
                    "exact_snippets": "Ascites",
                    "criterion": "ascites",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastric outlet obstruction",
            "criterions": [
                {
                    "exact_snippets": "Gastric outlet obstruction",
                    "criterion": "gastric outlet obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Respiratory failure requires supplementation of oxygen.",
            "criterions": [
                {
                    "exact_snippets": "Respiratory failure requires supplementation of oxygen.",
                    "criterion": "respiratory failure",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "supplementation of oxygen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immune deficiency syndrome, such as active tuberculosis and HIV infection.",
            "criterions": [
                {
                    "exact_snippets": "Immune deficiency syndrome",
                    "criterion": "immune deficiency syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematological precancerous diseases, such as myelodysplastic syndromes.",
            "criterions": [
                {
                    "exact_snippets": "Hematological precancerous diseases, such as myelodysplastic syndromes.",
                    "criterion": "hematological precancerous diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia)",
                    "criterion": "major cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "during the past six months of enrollment",
                    "criterion": "time since major cardiovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings",
            "criterions": [
                {
                    "exact_snippets": "Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline chest CT scan or chest X-ray findings",
                    "criterion": "baseline chest CT scan or chest X-ray findings",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)",
            "criterions": [
                {
                    "exact_snippets": "Previous or physical findings of central nervous system disease",
                    "criterion": "central nervous system disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... primary brain tumors",
                    "criterion": "primary brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... uncontrolled seizures",
                    "criterion": "uncontrolled seizures",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... strokes with standard medications",
                    "criterion": "strokes",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Preexisting neuropathy > 1 (NCI CTCAE).",
            "criterions": [
                {
                    "exact_snippets": "Preexisting neuropathy > 1 (NCI CTCAE)",
                    "criterion": "preexisting neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "NCI CTCAE"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.",
            "criterions": [
                {
                    "exact_snippets": "Allograft requires immunosuppressive therapy",
                    "criterion": "allograft",
                    "requirements": [
                        {
                            "requirement_type": "therapy",
                            "expected_value": "immunosuppressive"
                        }
                    ]
                },
                {
                    "exact_snippets": "other major immunosuppressive therapies",
                    "criterion": "immunosuppressive therapies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "major"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe serious wounds, ulcers or fractures.",
            "criterions": [
                {
                    "exact_snippets": "Severe serious wounds",
                    "criterion": "wounds",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe serious ... ulcers",
                    "criterion": "ulcers",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe serious ... fractures",
                    "criterion": "fractures",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed coagulant disease.",
            "criterions": [
                {
                    "exact_snippets": "Confirmed coagulant disease",
                    "criterion": "coagulant disease",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical evaluation is unacceptable.",
            "criterions": [
                {
                    "exact_snippets": "Clinical evaluation is unacceptable.",
                    "criterion": "clinical evaluation",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}