{
    "info": {
        "nct_id": "NCT03281382",
        "official_title": "PHASE 1 TRIAL OF ONCOLYTIC ADENOVIRUS-MEDIATED CYTOTOXIC AND IL-12 GENE THERAPY IN COMBINATION WITH CHEMOTHERAPY FOR THE TREATMENT OF METASTATIC PANCREATIC CANCER",
        "inclusion_criteria": "* Histologically proven (biopsy or cytology) metastatic pancreatic adenocarcinoma.\n* Age ≥ 18 years.\n* No prior treatment (surgery, chemotherapy, radiotherapy, or biological therapy) for the study cancer.\n* Zubrod performance score of 0 - 2 within 30 days of registration.\n* Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:\n\n  * Adequate renal function with serum creatinine ≤ 1.8 mg/dL or creatinine clearance ≥ 50 mL/min/m2.\n  * Absolute neutrophil count > 1,000/μL.\n  * Hemoglobin > 8.0 g/dL.\n  * Platelet count > 100,000/μL.\n  * Bilirubin < 2.0 mg/dL.\n  * SGOT and SGPT < 3.0 times upper limit of normal (ULN). Subjects with liver metastases may have SGOT/SGPT < 5.0 times ULN.\n* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout and for 60 days beyond the treatment phase of the study.\n* Subjects on oral warfarin anticoagulation therapy may be included in this study, but must have close monitoring of their coagulation parameters as altered parameters and/or bleeding have been reported in patients taking Xeloda® and such agents concomitantly. Subjects on other forms of anti-coagulation therapies may need close clinical monitoring for signs or symptoms of bleeding.\n* The subject must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant and lactating women.\n* Clinical or laboratory evidence of pancreatitis, based on discretion of treating physician.\n* Serious non-malignant disease (e.g., congestive heart failure or uncontrolled infections), which, in the opinion of the investigator would compromise study objectives.\n* Major surgery planned within 3 months of registration other than diagnostic procedures such as laparoscopy or endoscopic ultrasound and stenting or PEG/PEJ placement.\n* Islet cell tumor, benign cyst, peri-ampullary carcinoma or any non-adenocarcinomas.\n* Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required specific therapy within 72 hours of initiation of the study therapy (defined as day 1).\n* Previous history of liver disease including hepatitis.\n* Positive serologic test for Hepatitis B or C at baseline.\n* Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and topical corticosteroids is permitted.\n* Impaired immunity or susceptibility to serious viral infections.\n* Allergy to any product used on the protocol.\n* Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically proven (biopsy or cytology) metastatic pancreatic adenocarcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven (biopsy or cytology)",
                    "criterion": "histological proof",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "biopsy",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic pancreatic adenocarcinoma",
                    "criterion": "pancreatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior treatment (surgery, chemotherapy, radiotherapy, or biological therapy) for the study cancer.",
            "criterions": [
                {
                    "exact_snippets": "No prior treatment (surgery, chemotherapy, radiotherapy, or biological therapy)",
                    "criterion": "prior treatment for the study cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Zubrod performance score of 0 - 2 within 30 days of registration.",
            "criterions": [
                {
                    "exact_snippets": "Zubrod performance score of 0 - 2",
                    "criterion": "Zubrod performance score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days of registration",
                    "criterion": "timeframe for performance score assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 30 days of registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:",
            "criterions": [
                {
                    "exact_snippets": "adequate baseline organ function",
                    "criterion": "baseline organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days before initiating the study therapy",
                    "criterion": "timeframe for laboratory values",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 30 days before initiating the study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate renal function with serum creatinine ≤ 1.8 mg/dL or creatinine clearance ≥ 50 mL/min/m2.",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function with serum creatinine ≤ 1.8 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.8,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate renal function ... creatinine clearance ≥ 50 mL/min/m2",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count > 1,000/μL.",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 1,000/μL.",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 8.0 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 8.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100,000/μL.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100,000/μL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "/μL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin < 2.0 mg/dL.",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* SGOT and SGPT < 3.0 times upper limit of normal (ULN). Subjects with liver metastases may have SGOT/SGPT < 5.0 times ULN.",
            "criterions": [
                {
                    "exact_snippets": "SGOT and SGPT < 3.0 times upper limit of normal (ULN)",
                    "criterion": "SGOT and SGPT levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 3.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects with liver metastases may have SGOT/SGPT < 5.0 times ULN",
                    "criterion": "SGOT and SGPT levels with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 5.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout and for 60 days beyond the treatment phase of the study.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male participants",
                    "criterion": "male participants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use a medically effective means of birth control",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "throughout and for 60 days beyond the treatment phase of the study",
                    "criterion": "duration of birth control use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout and for 60 days beyond the treatment phase of the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects on oral warfarin anticoagulation therapy may be included in this study, but must have close monitoring of their coagulation parameters as altered parameters and/or bleeding have been reported in patients taking Xeloda® and such agents concomitantly. Subjects on other forms of anti-coagulation therapies may need close clinical monitoring for signs or symptoms of bleeding.",
            "criterions": [
                {
                    "exact_snippets": "Subjects on oral warfarin anticoagulation therapy",
                    "criterion": "oral warfarin anticoagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have close monitoring of their coagulation parameters",
                    "criterion": "coagulation parameters",
                    "requirements": [
                        {
                            "requirement_type": "monitoring",
                            "expected_value": "close"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects on other forms of anti-coagulation therapies",
                    "criterion": "other forms of anti-coagulation therapies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "may need close clinical monitoring for signs or symptoms of bleeding",
                    "criterion": "signs or symptoms of bleeding",
                    "requirements": [
                        {
                            "requirement_type": "monitoring",
                            "expected_value": "close clinical"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": "ability to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "express a willingness to meet all of the expected requirements of the protocol for the duration of the study",
                    "criterion": "willingness to meet protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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": "* Pregnant and lactating women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical or laboratory evidence of pancreatitis, based on discretion of treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Clinical or laboratory evidence of pancreatitis",
                    "criterion": "pancreatitis",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious non-malignant disease (e.g., congestive heart failure or uncontrolled infections), which, in the opinion of the investigator would compromise study objectives.",
            "criterions": [
                {
                    "exact_snippets": "Serious non-malignant disease (e.g., congestive heart failure or uncontrolled infections)",
                    "criterion": "serious non-malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the investigator would compromise study objectives",
                    "criterion": "compromise study objectives",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery planned within 3 months of registration other than diagnostic procedures such as laparoscopy or endoscopic ultrasound and stenting or PEG/PEJ placement.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery planned within 3 months of registration",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than diagnostic procedures such as laparoscopy or endoscopic ultrasound and stenting or PEG/PEJ placement",
                    "criterion": "diagnostic procedures",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "laparoscopy",
                                "endoscopic ultrasound",
                                "stenting",
                                "PEG/PEJ placement"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Islet cell tumor, benign cyst, peri-ampullary carcinoma or any non-adenocarcinomas.",
            "criterions": [
                {
                    "exact_snippets": "Islet cell tumor",
                    "criterion": "islet cell tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "benign cyst",
                    "criterion": "benign cyst",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "peri-ampullary carcinoma",
                    "criterion": "peri-ampullary carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-adenocarcinomas",
                    "criterion": "non-adenocarcinomas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required specific therapy within 72 hours of initiation of the study therapy (defined as day 1).",
            "criterions": [
                {
                    "exact_snippets": "Acute infection ... any viral, bacterial, or fungal infection",
                    "criterion": "acute infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "required specific therapy within 72 hours of initiation of the study therapy",
                    "criterion": "specific therapy for infection",
                    "requirements": [
                        {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 72,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous history of liver disease including hepatitis.",
            "criterions": [
                {
                    "exact_snippets": "Previous history of liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "including hepatitis",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive serologic test for Hepatitis B or C at baseline.",
            "criterions": [
                {
                    "exact_snippets": "Positive serologic test for Hepatitis B",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "serologic test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Positive serologic test for ... C",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "serologic test result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and topical corticosteroids is permitted.",
            "criterions": [
                {
                    "exact_snippets": "Immunosuppressive therapy including systemic corticosteroids.",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Use of inhaled and topical corticosteroids is permitted.",
                    "criterion": "inhaled and topical corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Impaired immunity or susceptibility to serious viral infections.",
            "criterions": [
                {
                    "exact_snippets": "Impaired immunity",
                    "criterion": "immunity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "impaired"
                        }
                    ]
                },
                {
                    "exact_snippets": "susceptibility to serious viral infections",
                    "criterion": "susceptibility to viral infections",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergy to any product used on the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Allergy to any product used on the protocol.",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.",
            "criterions": [
                {
                    "exact_snippets": "Serious medical ... might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.",
                    "criterion": "serious medical illness",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious ... psychiatric illness ... might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.",
                    "criterion": "serious psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "concomitant medication ... might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.",
                    "criterion": "concomitant medication",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}