{
    "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": [
        {
            "line": "1. Patients with HCC who received curative liver resection (R0);",
            "criterions": [
                {
                    "exact_snippets": "Patients with HCC",
                    "criterion": "HCC",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received curative liver resection (R0)",
                    "criterion": "curative liver resection (R0)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Karnofsky Performance Score performance over 60;",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Score performance over 60",
                    "criterion": "Karnofsky Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "performance",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "A",
                                "B"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients should sign the informed consent of this study.",
            "criterions": [
                {
                    "exact_snippets": "Patients should sign the 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 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "Child C"
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Severe gastroesophagealvarices with red sign or with variceal hemorrhage before;",
            "criterions": [
                {
                    "exact_snippets": "Severe gastroesophagealvarices",
                    "criterion": "gastroesophageal varices",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "with red sign",
                    "criterion": "gastroesophageal varices red sign",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with variceal hemorrhage before",
                    "criterion": "variceal hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients can not be followed-up regularly;",
            "criterions": [
                {
                    "exact_snippets": "Patients can not be followed-up regularly",
                    "criterion": "follow-up capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "received other treatment previously",
                    "criterion": "previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "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",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "functions of the heart ... are normal",
                    "criterion": "heart function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "functions of the lung ... are normal",
                    "criterion": "lung function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "functions of ... the blood system are normal",
                    "criterion": "blood system function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "fittable for Licardin therapy",
                    "criterion": "fittability for Licardin therapy",
                    "requirements": [
                        {
                            "requirement_type": "fittability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}