{
"info": {
"nct_id": "NCT01781520",
"official_title": "Dendritic Cell/Cytokine-Induced Killer Cell Immunotherapy Combined With S-1 in Patients With Advanced Pancreatic Cancer: A Prospective Study.",
"inclusion_criteria": "* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.\n* Capable of oral intake\n* Between 18 and 80 years old\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria\n* Karnofsky Performance Status (KPS) ≥ 70%\n* Normal functions of heart, lung and bone marrow\n* Adequate hematological profile: Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3\n* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN\n* Adequate renal function(normal serum creatinine level)\n* A life expectancy≥ 2 months\n* Informed consent signed\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study\n* Any radiotherapy or surgery within the previous 3 weeks\n* Symptomatic brain metastasis not controlled by corticosteroids\n* Bone marrow metastasis\n* Active infection\n* Serious complications\n* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.\n* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Capable of oral intake",
"criterions": [
{
"exact_snippets": "Capable of oral intake",
"criterion": "oral intake capability",
"requirement": {
"requirement_type": "capability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Capable of oral intake",
"criterion": "oral intake capability",
"requirement": {
"requirement_type": "capability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Between 18 and 80 years old",
"criterions": [
{
"exact_snippets": "Between 18 and 80 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Between 18 and 80 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 80,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
"criterions": [
{
"exact_snippets": "Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) criteria"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "definition",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) criteria"
}
}
]
}
},
{
"identified_line": {
"line": "* Karnofsky Performance Status (KPS) ≥ 70%",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Status (KPS) ≥ 70%",
"criterion": "Karnofsky Performance Status (KPS)",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky Performance Status (KPS) ≥ 70%",
"criterion": "Karnofsky Performance Status (KPS)",
"requirement": {
"requirement_type": "score",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Normal functions of heart, lung and bone marrow",
"criterions": [
{
"exact_snippets": "Normal functions of heart",
"criterion": "heart function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal functions of ... lung",
"criterion": "lung function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal functions of ... bone marrow",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Normal functions of heart",
"criterion": "heart function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal functions of ... lung",
"criterion": "lung function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
},
{
"exact_snippets": "Normal functions of ... bone marrow",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "functionality",
"expected_value": "normal"
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hematological profile: Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3",
"criterions": [
{
"exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "Absolute granulocyte count ≥ 1,500/mm3",
"criterion": "absolute granulocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count ≥ 100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin ≥ 9.0 g/dL",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 9.0,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "Absolute granulocyte count ≥ 1,500/mm3",
"criterion": "absolute granulocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count ≥ 100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN",
"criterions": [
{
"exact_snippets": "Adequate hepatic function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "Total bilirubin level≤ 3.0 times the upper limit of normal (ULN)",
"criterion": "total bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3.0,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN",
"criterion": "transaminases AST (SGOT) and ALT (SGPT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hepatic function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "adequate"
}
},
{
"exact_snippets": "Total bilirubin level≤ 3.0 times the upper limit of normal (ULN)",
"criterion": "total bilirubin level",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3.0,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN",
"criterion": "transaminases AST (SGOT) and ALT (SGPT)",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 2.5,
"unit": "times ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate renal function(normal serum creatinine level)",
"criterions": [
{
"exact_snippets": "Adequate renal function(normal serum creatinine level)",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "normal serum creatinine level"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate renal function(normal serum creatinine level)",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": "normal serum creatinine level"
}
}
]
}
},
{
"identified_line": {
"line": "* A life expectancy≥ 2 months",
"criterions": [
{
"exact_snippets": "life expectancy≥ 2 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "life expectancy≥ 2 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Informed consent signed",
"criterions": [
{
"exact_snippets": "Informed consent signed",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Informed consent signed",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study",
"criterions": [
{
"exact_snippets": "Current enrollment in another clinical study with an investigational agent",
"criterion": "enrollment in another clinical study",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Current enrollment in another clinical study with an investigational agent",
"criterion": "enrollment in another clinical study",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Current enrollment in another clinical study with an investigational agent",
"criterion": "enrollment in another clinical study",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Any radiotherapy or surgery within the previous 3 weeks",
"criterions": [
{
"exact_snippets": "Any radiotherapy ... within the previous 3 weeks",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Any ... surgery within the previous 3 weeks",
"criterion": "surgery",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Any radiotherapy ... within the previous 3 weeks",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
},
{
"exact_snippets": "Any ... surgery within the previous 3 weeks",
"criterion": "surgery",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Symptomatic brain metastasis not controlled by corticosteroids",
"criterions": [
{
"exact_snippets": "Symptomatic brain metastasis",
"criterion": "brain metastasis",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
},
{
"exact_snippets": "not controlled by corticosteroids",
"criterion": "corticosteroid control",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Symptomatic brain metastasis",
"criterion": "brain metastasis",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
},
{
"exact_snippets": "not controlled by corticosteroids",
"criterion": "corticosteroid control",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Bone marrow metastasis",
"criterions": [
{
"exact_snippets": "Bone marrow metastasis",
"criterion": "bone marrow metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Bone marrow metastasis",
"criterion": "bone marrow metastasis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Active infection",
"criterions": [
{
"exact_snippets": "Active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Active infection",
"criterion": "infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Serious complications",
"criterions": [
{
"exact_snippets": "Serious complications",
"criterion": "serious complications",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Serious complications",
"criterion": "serious complications",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.",
"criterions": [
{
"exact_snippets": "Receiving a concomitant treatment with drugs interacting with S-1",
"criterion": "concomitant treatment with drugs interacting with S-1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "phenytoin",
"criterion": "phenytoin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "potassium warfarin",
"criterion": "potassium warfarin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "flucytosine",
"criterion": "flucytosine",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "cimetidine",
"criterion": "cimetidine",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "folinic acid",
"criterion": "folinic acid",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "Receiving a concomitant treatment with drugs interacting with S-1",
"criterion": "concomitant treatment with drugs interacting with S-1",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"or_criteria": [
{
"not_criteria": {
"exact_snippets": "phenytoin",
"criterion": "phenytoin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "potassium warfarin",
"criterion": "potassium warfarin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "flucytosine",
"criterion": "flucytosine",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "cimetidine",
"criterion": "cimetidine",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
},
{
"not_criteria": {
"exact_snippets": "folinic acid",
"criterion": "folinic acid",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
]
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "adenocarcinoma confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "locally advanced, unresectable or metastatic adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"unresectable",
"metastatic"
]
}
},
{
"exact_snippets": "adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma location",
"requirement": {
"requirement_type": "location",
"expected_value": "pancreas"
}
},
{
"exact_snippets": "not amenable to curative radiotherapy or surgery",
"criterion": "treatment amenability",
"requirement": {
"requirement_type": "amenability",
"expected_value": [
"not amenable to curative radiotherapy",
"not amenable to surgery"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "adenocarcinoma confirmation method",
"requirement": {
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
},
{
"exact_snippets": "locally advanced, unresectable or metastatic adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma stage",
"requirement": {
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"unresectable",
"metastatic"
]
}
}
]
},
{
"exact_snippets": "adenocarcinoma of the pancreas",
"criterion": "adenocarcinoma location",
"requirement": {
"requirement_type": "location",
"expected_value": "pancreas"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "not amenable to curative radiotherapy or surgery",
"criterion": "treatment amenability",
"requirement": {
"requirement_type": "amenability",
"expected_value": "not amenable to curative radiotherapy"
}
},
{
"exact_snippets": "not amenable to curative radiotherapy or surgery",
"criterion": "treatment amenability",
"requirement": {
"requirement_type": "amenability",
"expected_value": "not amenable to surgery"
}
}
]
}
]
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy",
"criterions": [
{
"exact_snippets": "Pregnant ... women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactation women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "women with known or suspected pregnancy",
"criterion": "known or suspected pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "men who want let to pregnancy",
"criterion": "men's intention for pregnancy",
"requirement": {
"requirement_type": "intention",
"expected_value": "not to cause pregnancy"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Pregnant ... women",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "women with known or suspected pregnancy",
"criterion": "known or suspected pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "lactation women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "men who want let to pregnancy",
"criterion": "men's intention for pregnancy",
"requirement": {
"requirement_type": "intention",
"expected_value": "to cause pregnancy"
}
}
]
}
}
],
"failed_miscellaneous": []
}