{
    "info": {
        "nct_id": "NCT06662760",
        "official_title": "A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers",
        "inclusion_criteria": "* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；\n* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；\n* Histologically or cytologically diagnosed with advanced cancers\n* Subjects with advanced malignancies who have failed standard therapy or lack effective treatment\n* Major organs are functioning well；\n* Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* Current concomitant presence of other malignancies within 5 years prior to the first dose；\n* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy\n* Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose\n* Long-term unhealed wounds or fractures\n* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose\n* Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy\n* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder\n* Subjects with any severe and/or uncontrolled disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；",
            "criterions": [
                {
                    "exact_snippets": "Subjects voluntarily joined this study",
                    "criterion": "voluntary participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed the informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had good compliance",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "good"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；",
            "criterions": [
                {
                    "exact_snippets": "Age: 18-75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (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": "Expected survival of more than 3 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically diagnosed with advanced cancers",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically diagnosed with advanced cancers",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with advanced malignancies who have failed standard therapy or lack effective treatment",
            "criterions": [
                {
                    "exact_snippets": "advanced malignancies",
                    "criterion": "malignancy stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "failed standard therapy",
                    "criterion": "standard therapy outcome",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                },
                {
                    "exact_snippets": "lack effective treatment",
                    "criterion": "availability of effective treatment",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major organs are functioning well；",
            "criterions": [
                {
                    "exact_snippets": "Major organs are functioning well",
                    "criterion": "major organ function",
                    "requirements": [
                        {
                            "requirement_type": "functionality",
                            "expected_value": "well"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.",
            "criterions": [
                {
                    "exact_snippets": "Female and male subjects of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "should agree to practice contraception for the duration of the study and for 6 months after the end of the study",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "for the duration of the study and for 6 months after the end of the study"
                        }
                    ]
                }
            ]
        },
        {
            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Current concomitant presence of other malignancies within 5 years prior to the first dose；",
            "criterions": [
                {
                    "exact_snippets": "Current concomitant presence of other malignancies",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 5 years prior to the first dose",
                    "criterion": "time since other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy",
            "criterions": [
                {
                    "exact_snippets": "Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy",
                    "criterion": "toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose",
            "criterions": [
                {
                    "exact_snippets": "Significant surgical treatment",
                    "criterion": "surgical treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "biopsy",
                    "criterion": "biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant traumatic injury",
                    "criterion": "traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Long-term unhealed wounds or fractures",
            "criterions": [
                {
                    "exact_snippets": "Long-term unhealed wounds",
                    "criterion": "wounds",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "long-term"
                        }
                    ]
                },
                {
                    "exact_snippets": "Long-term unhealed ... fractures",
                    "criterion": "fractures",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "long-term"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose",
            "criterions": [
                {
                    "exact_snippets": "Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction) ... within 6 months prior to the first dose",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "deep vein thrombosis ... within 6 months prior to the first dose",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary embolism within 6 months prior to the first dose",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy",
            "criterions": [
                {
                    "exact_snippets": "Swallowing dysfunction",
                    "criterion": "swallowing dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active gastrointestinal diseases",
                    "criterion": "active gastrointestinal diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug",
                    "criterion": "diseases affecting drug absorption, distribution, metabolism, and excretion",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous subtotal gastrectomy",
                    "criterion": "previous subtotal gastrectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder",
            "criterions": [
                {
                    "exact_snippets": "A history of psychotropic drug abuse",
                    "criterion": "psychotropic drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be abstained from",
                    "criterion": "psychotropic drug abstinence",
                    "requirements": [
                        {
                            "requirement_type": "ability to abstain",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have a mental disorder",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any severe and/or uncontrolled disease",
            "criterions": [
                {
                    "exact_snippets": "any severe and/or uncontrolled disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}