{
    "info": {
        "nct_id": "NCT03177382",
        "official_title": "Total Neoadjuvant Treatment Versus Conventional Neo-chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk Factors: a Multicenter Randomized Phase III Clinical Study.",
        "inclusion_criteria": "（1）Age: 18 ~ 70 years old; sex is not limited. （2）Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a-b(resectable)；cT3c-d with EMVI+ (Extramural venous invasion)；cN2；MRF+ (MRI in evaluating the mesorectal fascia).（According to the 2010 AJCC cancer staging system, the seventh edition）. The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging examinations are needed（cranial MRI or ECT）.\n\n（3）The lower edge of lesion is less than 12cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.\n\n（4）No distant metastasis after a thorough examination . （5）Pathological diagnosis of rectal adenocarcinoma. （6）ECOG score: 0-1. （7）Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy.\n\n（8）The main organ function is normal, including the following characteristics:\n\n* Blood routine examination: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L，PLT≥ 100×109/L\n\n  * Biochemical examination：Crea and BIL ≤ 1.0 upper normal limit（ULN），ALT and AST≤ 2.5 upper normal limit（ULN）.\n\n    （9）Not allergic to 5-Fu or Platinum. （10）The site of radiotherapy had not previously received radiation. （11）If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug.\n\n    （12）Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "（1）Have had prior or concurrent cancer distinct in primary site or histology EXCEPT for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.\n\n（2）Pregnant or lactating women. （3）Patients with severe cardiovascular disease and poorly controlled diabetes. （4）Mental disorder. （5）Severe infection. （6）Patients who can't finish MRI examination. （7）Patients were treated with thrombolytic therapy and anticoagulant therapy, either with bleeding diathesis or coagulopathy, or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year.\n\n（8）The past history of kidney disease, urine or urine protein found in clinical renal abnormalities.\n\n（9）The digestive tract fistula, perforation or serious ulcer disease. （10）Be allergic to 5-Fu or Platinum. （11）The presence of severe gastrointestinal diseases that affecting the absorption of oral chemotherapy drugs.\n\n（12）Additional clinical trials were attended within 4 weeks before treatment initiation.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "（1）Age: 18 ~ 70 years old; sex is not limited. （2）Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a-b(resectable)；cT3c-d with EMVI+ (Extramural venous invasion)；cN2；MRF+ (MRI in evaluating the mesorectal fascia).（According to the 2010 AJCC cancer staging system, the seventh edition）. The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging examinations are needed（cranial MRI or ECT）.",
            "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"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "sex is not limited",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "limitation",
                            "expected_value": "not limited"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with stage II/III rectal cancer",
                    "criterion": "rectal cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "staged under MRI or endoscopic ultrasonography",
                    "criterion": "staging method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "MRI",
                                "endoscopic ultrasonography"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one risk factor: cT4a-b(resectable)",
                    "criterion": "risk factor cT4a-b",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "resectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one risk factor: ... cT3c-d with EMVI+ (Extramural venous invasion)",
                    "criterion": "risk factor cT3c-d with EMVI+",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "EMVI+"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one risk factor: ... cN2",
                    "criterion": "risk factor cN2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one risk factor: ... MRF+ (MRI in evaluating the mesorectal fascia)",
                    "criterion": "risk factor MRF+",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "MRF+"
                        }
                    ]
                },
                {
                    "exact_snippets": "According to the 2010 AJCC cancer staging system, the seventh edition",
                    "criterion": "cancer staging system",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "2010 AJCC, seventh edition"
                        }
                    ]
                },
                {
                    "exact_snippets": "The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI",
                    "criterion": "preoperative T stage method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "endoscopic ultrasonography",
                                "rectal MRI"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "The N stage is referred to abdominal CT",
                    "criterion": "N stage method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "abdominal CT"
                        }
                    ]
                },
                {
                    "exact_snippets": "The M stage is referred to abdominal and thoracic CT",
                    "criterion": "M stage method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "abdominal CT",
                                "thoracic CT"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "If symptoms occur, other appropriate imaging examinations are needed（cranial MRI or ECT）",
                    "criterion": "additional imaging examinations",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "if symptoms occur"
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "cranial MRI",
                                "ECT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "（3）The lower edge of lesion is less than 12cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.",
            "criterions": [
                {
                    "exact_snippets": "The lower edge of lesion is less than 12cm from anal verge",
                    "criterion": "distance of lesion from anal verge",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "（4）No distant metastasis after a thorough examination . （5）Pathological diagnosis of rectal adenocarcinoma. （6）ECOG score: 0-1. （7）Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy.",
            "criterions": [
                {
                    "exact_snippets": "No distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pathological diagnosis of rectal adenocarcinoma",
                    "criterion": "rectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "pathological"
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG score: 0-1",
                    "criterion": "ECOG score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with primary rectal cancer",
                    "criterion": "primary rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received surgery prior to surgery (except for palliative ileostomy or colostomy)",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received ... systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "had not received ... other anti-tumor therapy",
                    "criterion": "other anti-tumor therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "（8）The main organ function is normal, including the following characteristics:",
            "criterions": [
                {
                    "exact_snippets": "The main organ function is normal",
                    "criterion": "main organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Blood routine examination: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L，PLT≥ 100×109/L",
            "criterions": [
                {
                    "exact_snippets": "Blood routine examination: HB ≥9g/dL",
                    "criterion": "hemoglobin (HB) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood routine examination: ... WBC ≥ 3.5/4.0×109/L",
                    "criterion": "white blood cell (WBC) count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.5,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Blood routine examination: ... PLT≥ 100×109/L",
                    "criterion": "platelet (PLT) count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biochemical examination：Crea and BIL ≤ 1.0 upper normal limit（ULN），ALT and AST≤ 2.5 upper normal limit（ULN）.",
            "criterions": [
                {
                    "exact_snippets": "Crea and BIL ≤ 1.0 upper normal limit（ULN）",
                    "criterion": "creatinine (Crea) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Crea and BIL ≤ 1.0 upper normal limit（ULN）",
                    "criterion": "bilirubin (BIL) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.0,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST≤ 2.5 upper normal limit（ULN）",
                    "criterion": "alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT and AST≤ 2.5 upper normal limit（ULN）",
                    "criterion": "aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "（9）Not allergic to 5-Fu or Platinum. （10）The site of radiotherapy had not previously received radiation. （11）If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Not allergic to 5-Fu",
                    "criterion": "allergy to 5-Fu",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Not allergic to ... Platinum",
                    "criterion": "allergy to Platinum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The site of radiotherapy had not previously received radiation",
                    "criterion": "previous radiation at radiotherapy site",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "If female and of childbearing potential, or if male, agree to use adequate contraception ... from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug",
                    "criterion": "use of adequate contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "（12）Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Participants are volunteered to participate in this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sign informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                },
                {
                    "exact_snippets": "cooperation with follow-up",
                    "criterion": "cooperation with follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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 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）Have had prior or concurrent cancer distinct in primary site or histology EXCEPT for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.",
            "criterions": [
                {
                    "exact_snippets": "prior or concurrent cancer distinct in primary site or histology",
                    "criterion": "prior or concurrent cancer",
                    "requirements": [
                        {
                            "requirement_type": "distinctness",
                            "expected_value": "distinct in primary site or histology"
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively treated cervical cancer in situ",
                    "criterion": "cervical cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Basal cell carcinoma of skin",
                    "criterion": "Basal cell carcinoma of skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "（2）Pregnant or lactating women. （3）Patients with severe cardiovascular disease and poorly controlled diabetes. （4）Mental disorder. （5）Severe infection. （6）Patients who can't finish MRI examination. （7）Patients were treated with thrombolytic therapy and anticoagulant therapy, either with bleeding diathesis or coagulopathy, or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant or lactating women",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who can't finish MRI examination",
                    "criterion": "ability to finish MRI examination",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with thrombolytic therapy and anticoagulant therapy",
                    "criterion": "thrombolytic therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with thrombolytic therapy and anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "aneurysm",
                    "criterion": "aneurysm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "arteriovenous malformation",
                    "criterion": "arteriovenous malformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the past year",
                    "criterion": "time frame for conditions",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "（8）The past history of kidney disease, urine or urine protein found in clinical renal abnormalities.",
            "criterions": [
                {
                    "exact_snippets": "past history of kidney disease",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "urine or urine protein found in clinical renal abnormalities",
                    "criterion": "urine or urine protein",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "（9）The digestive tract fistula, perforation or serious ulcer disease. （10）Be allergic to 5-Fu or Platinum. （11）The presence of severe gastrointestinal diseases that affecting the absorption of oral chemotherapy drugs.",
            "criterions": [
                {
                    "exact_snippets": "digestive tract fistula",
                    "criterion": "digestive tract fistula",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "perforation",
                    "criterion": "perforation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serious ulcer disease",
                    "criterion": "ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to 5-Fu",
                    "criterion": "allergy to 5-Fu",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergic to ... Platinum",
                    "criterion": "allergy to Platinum",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of severe gastrointestinal diseases ... affecting the absorption of oral chemotherapy drugs",
                    "criterion": "gastrointestinal diseases affecting absorption of oral chemotherapy drugs",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "（12）Additional clinical trials were attended within 4 weeks before treatment initiation.",
            "criterions": [
                {
                    "exact_snippets": "Additional clinical trials were attended within 4 weeks before treatment initiation.",
                    "criterion": "attendance of additional clinical trials",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}