{
    "info": {
        "nct_id": "NCT05425472",
        "official_title": "An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer",
        "inclusion_criteria": "1. ECOG performance status 0 or 1\n2. Histologically confirmed advanced esophageal carcinoma\n3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)\n4. Able and willing to provide a written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. The tumor obviously invades adjacent organs of esophageal lesions\n2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening\n3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment\n4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. ECOG performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically confirmed advanced esophageal carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced esophageal carcinoma",
                    "criterion": "esophageal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)",
            "criterions": [
                {
                    "exact_snippets": "At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Able and willing to provide a written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able ... to provide a written informed consent",
                    "criterion": "ability to provide consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to provide a written informed consent",
                    "criterion": "willingness to provide consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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 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": "1. The tumor obviously invades adjacent organs of esophageal lesions",
            "criterions": [
                {
                    "exact_snippets": "tumor ... invades adjacent organs",
                    "criterion": "tumor invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal lesions",
                    "criterion": "esophageal lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening",
            "criterions": [
                {
                    "exact_snippets": "BMI≤18.5 kg/m2",
                    "criterion": "BMI",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 18.5,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "weight loss ≥10% within 2 months prior to screening",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment",
            "criterions": [
                {
                    "exact_snippets": "unresolved adverse effects of prior therapy",
                    "criterion": "adverse effects of prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently",
            "criterions": [
                {
                    "exact_snippets": "Subjects who had received anti-tumor treatments such as surgery",
                    "criterion": "anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "surgery",
                                "chemotherapy",
                                "radiotherapy"
                            ]
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": "recently"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}