{
"info": {
"nct_id": "NCT04521491",
"official_title": "A Randomized Controlled Study on the Effect of Postoperative Adjuvant Chemotherapy With FOLFOX4 After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells",
"inclusion_criteria": "1. Patients with HCC who received curative liver resection (R0);\n2. Karnofsky Performance Score performance over 60;\n3. The functions of the kidney, heart and lung and the blood system are normal and fittable for Licardin therapy;\n4. The liver function is of grade A or B in Child-Pugh classification;\n5. Patients agreed to collect peripheral blood for detection of CTC at the designated time point;\n6. Patients should sign the informed consent of this study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. If postoperative liver function is Child C, it cannot tolerate chemotherapy;\n2. Blood transfusion history within 1 month before enrollment;\n3. Severe gastroesophagealvarices with red sign or with variceal hemorrhage before;\n4. Malignant or metastatic tumor in other sites in last 5 years;\n5. Patients can not be followed-up regularly;\n6. Patients participating in other trials or received other treatment previously.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Patients with HCC who received curative liver resection (R0);",
"criterions": [
{
"exact_snippets": "Patients with HCC",
"criterion": "HCC",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received curative liver resection (R0)",
"criterion": "curative liver resection (R0)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients with HCC",
"criterion": "HCC",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "received curative liver resection (R0)",
"criterion": "curative liver resection (R0)",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "2. Karnofsky Performance Score performance over 60;",
"criterions": [
{
"exact_snippets": "Karnofsky Performance Score performance over 60",
"criterion": "Karnofsky Performance Score",
"requirement": {
"requirement_type": "performance",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Karnofsky Performance Score performance over 60",
"criterion": "Karnofsky Performance Score",
"requirement": {
"requirement_type": "performance",
"expected_value": {
"operator": ">",
"value": 60,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "4. The liver function is of grade A or B in Child-Pugh classification;",
"criterions": [
{
"exact_snippets": "liver function ... grade A or B in Child-Pugh classification",
"criterion": "liver function",
"requirement": {
"requirement_type": "grade",
"expected_value": [
"A",
"B"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "liver function ... grade A or B in Child-Pugh classification",
"criterion": "liver function",
"requirement": {
"requirement_type": "grade",
"expected_value": [
"A",
"B"
]
}
}
]
}
},
{
"identified_line": {
"line": "5. Patients agreed to collect peripheral blood for detection of CTC at the designated time point;",
"criterions": [
{
"exact_snippets": "collect peripheral blood for detection of CTC",
"criterion": "peripheral blood collection for CTC detection",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "collect peripheral blood for detection of CTC",
"criterion": "peripheral blood collection for CTC detection",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "6. Patients should sign the informed consent of this study.",
"criterions": [
{
"exact_snippets": "Patients should sign the informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients should sign the informed consent",
"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"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. The functions of the kidney, heart and lung and the blood system are normal and fittable for Licardin therapy;",
"criterions": [
{
"exact_snippets": "functions of the kidney ... are normal",
"criterion": "kidney function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of the heart ... are normal",
"criterion": "heart function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of the lung ... are normal",
"criterion": "lung function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of ... the blood system are normal",
"criterion": "blood system function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "fittable for Licardin therapy",
"criterion": "fittability for Licardin therapy",
"requirement": {
"requirement_type": "fittability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "functions of the kidney ... are normal",
"criterion": "kidney function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "functions of the heart ... are normal",
"criterion": "heart function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
{
"exact_snippets": "functions of the lung ... are normal",
"criterion": "lung function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
{
"exact_snippets": "functions of ... the blood system are normal",
"criterion": "blood system function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
}
]
},
{
"exact_snippets": "fittable for Licardin therapy",
"criterion": "fittability for Licardin therapy",
"requirement": {
"requirement_type": "fittability",
"expected_value": true
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. If postoperative liver function is Child C, it cannot tolerate chemotherapy;",
"criterions": [
{
"exact_snippets": "postoperative liver function is Child C",
"criterion": "postoperative liver function",
"requirement": {
"requirement_type": "classification",
"expected_value": "Child C"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "postoperative liver function is Child C",
"criterion": "postoperative liver function",
"requirement": {
"requirement_type": "classification",
"expected_value": "Child C"
}
},
"then_criteria": {
"exact_snippets": "it cannot tolerate chemotherapy",
"criterion": "chemotherapy tolerance",
"requirement": {
"requirement_type": "tolerance",
"expected_value": false
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "2. Blood transfusion history within 1 month before enrollment;",
"criterions": [
{
"exact_snippets": "Blood transfusion history within 1 month before enrollment",
"criterion": "blood transfusion history",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Blood transfusion history within 1 month before enrollment",
"criterion": "blood transfusion history",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
}
},
{
"identified_line": {
"line": "3. Severe gastroesophagealvarices with red sign or with variceal hemorrhage before;",
"criterions": [
{
"exact_snippets": "Severe gastroesophagealvarices",
"criterion": "gastroesophageal varices",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "with red sign",
"criterion": "gastroesophageal varices red sign",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "with variceal hemorrhage before",
"criterion": "variceal hemorrhage",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Severe gastroesophagealvarices",
"criterion": "gastroesophageal varices",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "with red sign",
"criterion": "gastroesophageal varices red sign",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "with variceal hemorrhage before",
"criterion": "variceal hemorrhage",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Malignant or metastatic tumor in other sites in last 5 years;",
"criterions": [
{
"exact_snippets": "Malignant or metastatic tumor in other sites in last 5 years",
"criterion": "malignant or metastatic tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Malignant or metastatic tumor in other sites in last 5 years",
"criterion": "malignant or metastatic tumor",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Malignant or metastatic tumor in other sites in last 5 years",
"criterion": "malignant or metastatic tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Malignant or metastatic tumor in other sites in last 5 years",
"criterion": "malignant or metastatic tumor",
"requirement": {
"requirement_type": "time frame",
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"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "5. Patients can not be followed-up regularly;",
"criterions": [
{
"exact_snippets": "Patients can not be followed-up regularly",
"criterion": "follow-up capability",
"requirement": {
"requirement_type": "capability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Patients can not be followed-up regularly",
"criterion": "follow-up capability",
"requirement": {
"requirement_type": "capability",
"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "6. Patients participating in other trials or received other treatment previously.",
"criterions": [
{
"exact_snippets": "Patients participating in other trials",
"criterion": "participation in other trials",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "received other treatment previously",
"criterion": "previous treatment",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Patients participating in other trials",
"criterion": "participation in other trials",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "received other treatment previously",
"criterion": "previous treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}