{
    "info": {
        "nct_id": "NCT06603376",
        "official_title": "A Randomized, Multicenter, Controlled Study of Irinotecan Hydrochloride Liposome Injection (Ⅱ) Combined with Fluorouracil, Folinic Acid, Vermofenib and Cetuximab in First-line Treatment of BRAFV600E Mutated Advanced Colorectal Cancer",
        "inclusion_criteria": "* Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology.\n* Patients with BRAFV600E mutation confirmed by tissue or blood testing.\n* Patients who have not received systemic therapy or who have experienced metastasis or recurrence 12 months after completing adjuvant therapy.\n* Patients must have at least one measurable lesion according to RECIST 1.1 criteria.\n* Patients who received local radiotherapy at least 3 weeks before the first drug treatment are allowed to enroll, but lesions evaluated by RECIST should not be within the radiation field.\n* Patients aged ≥18 years and ≤80 years.\n* ECOG performance status of 0-2.\n* Expected survival of ≥12 weeks.\n* Patients must have the ability to understand and voluntarily sign a written informed consent.\n* Women of childbearing potential must have a negative pregnancy test within 7 days prior to the start of treatment. During the study, both the patient and their partner must use contraception.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug.\n* Patients with hypersensitivity to any component of the study regimen.\n* Patients who are planning to conceive or are already pregnant.\n* Patients with brain metastases who cannot accurately describe their condition.\n* Patients with the following conditions within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina, congestive heart failure greater than NYHA Class 2, uncontrolled arrhythmias, etc.\n* Abnormal laboratory test results:\n* Absolute neutrophil count (ANC) <1,500/mm³;\n* Platelet count <75,000/mm³;\n* Total bilirubin >1.5 times the upper limit of normal (ULN); ALT (alanine aminotransferase) and AST (aspartate aminotransferase) >2.5 times ULN (for patients with liver metastasis >5 times ULN); Creatinine >1.5 times ULN;\n* Patients who have had any cancer other than advanced colorectal cancer within five years prior to the start of the study treatment. Exceptions include cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors.\n* Patients with a history of drug abuse, substance abuse, or alcohol dependence.\n* Patients who are legally incapacitated or have limited civil capacity.\n* Any other conditions deemed unsuitable for enrollment by the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology.",
            "criterions": [
                {
                    "exact_snippets": "advanced colorectal adenocarcinoma",
                    "criterion": "colorectal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by histology or cytology",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with BRAFV600E mutation confirmed by tissue or blood testing.",
            "criterions": [
                {
                    "exact_snippets": "BRAFV600E mutation confirmed by tissue or blood testing",
                    "criterion": "BRAFV600E mutation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have not received systemic therapy or who have experienced metastasis or recurrence 12 months after completing adjuvant therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have not received systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrence 12 months after completing adjuvant therapy",
                    "criterion": "recurrence",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "12 months after completing adjuvant therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one measurable lesion according to RECIST 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion according to RECIST 1.1 criteria",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who received local radiotherapy at least 3 weeks before the first drug treatment are allowed to enroll, but lesions evaluated by RECIST should not be within the radiation field.",
            "criterions": [
                {
                    "exact_snippets": "Patients who received local radiotherapy at least 3 weeks before the first drug treatment",
                    "criterion": "local radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesions evaluated by RECIST should not be within the radiation field",
                    "criterion": "lesions evaluated by RECIST",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "not within the radiation field"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients aged ≥18 years and ≤80 years.",
            "criterions": [
                {
                    "exact_snippets": "aged ≥18 years and ≤80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected survival of ≥12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival of ≥12 weeks.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have the ability to understand and voluntarily sign a written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "voluntarily sign a written informed consent",
                    "criterion": "consent capability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential must have a negative pregnancy test within 7 days prior to the start of treatment. During the study, both the patient and their partner must use contraception.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative pregnancy test within 7 days prior to the start of treatment",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the start of treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "During the study, both the patient and their partner must use contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during the study"
                        },
                        {
                            "requirement_type": "participants",
                            "expected_value": [
                                "patient",
                                "partner"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug.",
            "criterions": [
                {
                    "exact_snippets": "undergone major surgery",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "suffered severe trauma",
                    "criterion": "severe trauma",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with hypersensitivity to any component of the study regimen.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to any component of the study regimen",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with brain metastases who cannot accurately describe their condition.",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot accurately describe their condition",
                    "criterion": "ability to describe condition",
                    "requirements": [
                        {
                            "requirement_type": "accuracy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with the following conditions within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina, congestive heart failure greater than NYHA Class 2, uncontrolled arrhythmias, etc.",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "severe/unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "severe",
                                "unstable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure greater than NYHA Class 2",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA Class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal laboratory test results:",
            "criterions": [
                {
                    "exact_snippets": "Abnormal laboratory test results",
                    "criterion": "laboratory test results",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had any cancer other than advanced colorectal cancer within five years prior to the start of the study treatment. Exceptions include cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had any cancer other than advanced colorectal cancer within five years prior to the start of the study treatment.",
                    "criterion": "history of cancer",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "any cancer other than advanced colorectal cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors.",
                    "criterion": "cancer exceptions",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "cervical carcinoma in situ",
                                "cured basal cell carcinoma",
                                "bladder epithelial tumors"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of drug abuse, substance abuse, or alcohol dependence.",
            "criterions": [
                {
                    "exact_snippets": "history of drug abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... alcohol dependence",
                    "criterion": "alcohol dependence",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are legally incapacitated or have limited civil capacity.",
            "criterions": [
                {
                    "exact_snippets": "legally incapacitated",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "incapacitated"
                        }
                    ]
                },
                {
                    "exact_snippets": "limited civil capacity",
                    "criterion": "civil capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "limited"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other conditions deemed unsuitable for enrollment by the investigator.",
            "criterions": [
                {
                    "exact_snippets": "Any other conditions deemed unsuitable for enrollment by the investigator.",
                    "criterion": "conditions deemed unsuitable",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "by the investigator"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients who are planning to conceive or are already pregnant.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are planning to conceive",
                    "criterion": "planning to conceive",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who are ... already pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) &lt;1,500/mm³;",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) <1,500/mm³;",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count &lt;75,000/mm³;",
            "criterions": [
                {
                    "exact_snippets": "Platelet count <75,000/mm³;",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 75000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin &gt;1.5 times the upper limit of normal (ULN); ALT (alanine aminotransferase) and AST (aspartate aminotransferase) &gt;2.5 times ULN (for patients with liver metastasis &gt;5 times ULN); Creatinine &gt;1.5 times ULN;",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin >1.5 times the upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT (alanine aminotransferase) and AST (aspartate aminotransferase) >2.5 times ULN",
                    "criterion": "ALT and AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "(for patients with liver metastasis >5 times ULN)",
                    "criterion": "ALT and AST for patients with liver metastasis",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine >1.5 times ULN",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}