{
    "info": {
        "nct_id": "NCT04733820",
        "official_title": "Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery",
        "inclusion_criteria": "1. Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.\n2. Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.\n3. Age：18-70 years old.\n4. ECOG status score ≤1;\n5. WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.\n6. Well-compliance and willing to keep in touch.\n7. Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "1. After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.\n2. Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.\n3. Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.\n4. Postoperative risk factors meet the Sedlis standard of the NCCN guideline.\n5. Participate in other clinical trials.\n6. Severe diseases of other important systems and organs.\n7. Persons without disposing capacity.\n8. Drug and/or alcohol abuse.\n9. Unable or unwilling to sign informed consents.\n10. Not eligible for the study judged by researchers.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard)",
                    "criterion": "cervical cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.3,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2.2,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor diameter > 4cm before treatment",
                    "criterion": "tumor diameter",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical squamous cell carcinoma",
                    "criterion": "cervical squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adenosquamous carcinoma",
                    "criterion": "adenosquamous carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Age：18-70 years old.",
            "criterions": [
                {
                    "exact_snippets": "Age：18-70 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 70,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. ECOG status score ≤1;",
            "criterions": [
                {
                    "exact_snippets": "ECOG status score ≤1",
                    "criterion": "ECOG status score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. WBC≥3.5*10^9/L, NEU≥1.5*10^9/L, Platelet≥80×10^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.",
            "criterions": [
                {
                    "exact_snippets": "WBC≥3.5*10^9/L",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "*10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "NEU≥1.5*10^9/L",
                    "criterion": "NEU",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "*10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet≥80×10^9 /L",
                    "criterion": "Platelet",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "×10^9 /L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT ≤1.5 times normal upper limit",
                    "criterion": "AST and ALT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times normal upper limit"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤1.5 times the upper limit of normal value",
                    "criterion": "Total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal value"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine and blood urea nitrogen ≤the upper limit of normal value",
                    "criterion": "serum creatinine and blood urea nitrogen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": "≤the upper limit of normal value"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Well-compliance and willing to keep in touch.",
            "criterions": [
                {
                    "exact_snippets": "Well-compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to keep in touch",
                    "criterion": "willingness to maintain contact",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.",
            "criterions": [
                {
                    "exact_snippets": "Able to sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol",
                    "criterion": "compliance with requirements and restrictions",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "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 be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.",
            "criterions": [
                {
                    "exact_snippets": "After 2-3 cycles of neoadjuvant chemotherapy",
                    "criterion": "neoadjuvant chemotherapy cycles",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "cycles"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "cycles"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients do not undergo laparotomic or laparoscopic extensive hysterectomy",
                    "criterion": "extensive hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients do not undergo ... pelvic lymph node dissection",
                    "criterion": "pelvic lymph node dissection",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer foci sealed before dissection of the vagina",
                    "criterion": "cervical cancer foci",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "sealed before dissection of the vagina"
                        }
                    ]
                },
                {
                    "exact_snippets": "without uterine manipulator",
                    "criterion": "uterine manipulator",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.",
            "criterions": [
                {
                    "exact_snippets": "Neoadjuvant chemotherapy regimens",
                    "criterion": "neoadjuvant chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "difference",
                            "expected_value": "postoperative adjuvant therapy regimens"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.",
            "criterions": [
                {
                    "exact_snippets": "lymph node metastasis",
                    "criterion": "lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "parauterine infiltration",
                    "criterion": "parauterine infiltration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive surgical margin",
                    "criterion": "surgical margin",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Postoperative risk factors meet the Sedlis standard of the NCCN guideline.",
            "criterions": [
                {
                    "exact_snippets": "Postoperative risk factors meet the Sedlis standard of the NCCN guideline",
                    "criterion": "postoperative risk factors",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "Sedlis standard of the NCCN guideline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Participate in other clinical trials.",
            "criterions": [
                {
                    "exact_snippets": "Participate in other clinical trials.",
                    "criterion": "participation in other clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Severe diseases of other important systems and organs.",
            "criterions": [
                {
                    "exact_snippets": "Severe diseases of other important systems and organs",
                    "criterion": "diseases of other important systems and organs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Persons without disposing capacity.",
            "criterions": [
                {
                    "exact_snippets": "without disposing capacity",
                    "criterion": "disposing capacity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Drug and/or alcohol abuse.",
            "criterions": [
                {
                    "exact_snippets": "Drug and/or alcohol abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Drug and/or alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Unable or unwilling to sign informed consents.",
            "criterions": [
                {
                    "exact_snippets": "Unable or unwilling to sign informed consents.",
                    "criterion": "ability and willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Not eligible for the study judged by researchers.",
            "criterions": [
                {
                    "exact_snippets": "Not eligible for the study judged by researchers.",
                    "criterion": "eligibility",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "researcher discretion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}