{
    "info": {
        "nct_id": "NCT05246982",
        "official_title": "An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer",
        "inclusion_criteria": "1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;\n2. Age ≥ 18 years and ≤ 75 years when ICF is signed;\n3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;\n4. Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);\n5. Measurable lesion according to RECIST v1.1 by IRRC;\n6. ECOG score 0-1;\n7. Expected survival 12 weeks.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Has other active malignancies within 5 years before the first administration of the study drug;\n2. Plan to or have previously received organ or bone marrow transplantation;\n3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n4. Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;\n5. Have received any research drugs within 14 days before the first use of the study drugs.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;",
                "criterions": [
                    {
                        "exact_snippets": "Volunteer to participate in this clinical study",
                        "criterion": "volunteer status",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "completely understand and know this study",
                        "criterion": "study understanding",
                        "requirement": {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "sign the informed consent form (ICF)",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing to follow and be able to complete all study procedures",
                        "criterion": "ability to follow study procedures",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing to follow and be able to complete all study procedures",
                        "criterion": "ability to follow study procedures",
                        "requirement": {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Volunteer to participate in this clinical study",
                                "criterion": "volunteer status",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "completely understand and know this study",
                                "criterion": "study understanding",
                                "requirement": {
                                    "requirement_type": "comprehension",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "sign the informed consent form (ICF)",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "signed",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "be willing to follow and be able to complete all study procedures",
                                "criterion": "ability to follow study procedures",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "be willing to follow and be able to complete all study procedures",
                                "criterion": "ability to follow study procedures",
                                "requirement": {
                                    "requirement_type": "capability",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;",
                "criterions": [
                    {
                        "exact_snippets": "Unresectable locally advanced, or metastatic gastric cancer",
                        "criterion": "gastric cancer",
                        "requirement": {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Unresectable locally advanced, or metastatic gastric cancer",
                        "criterion": "gastric cancer",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "gastroesophageal junction cancer",
                        "criterion": "gastroesophageal junction cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "histopathologically confirmed diagnosis of adenocarcinoma",
                        "criterion": "adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathological"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Unresectable locally advanced, or metastatic gastric cancer",
                                        "criterion": "gastric cancer",
                                        "requirement": {
                                            "requirement_type": "resectability",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "Unresectable locally advanced, or metastatic gastric cancer",
                                        "criterion": "gastric cancer",
                                        "requirement": {
                                            "requirement_type": "stage",
                                            "expected_value": [
                                                "locally advanced",
                                                "metastatic"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "gastroesophageal junction cancer",
                                "criterion": "gastroesophageal junction cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "histopathologically confirmed diagnosis of adenocarcinoma",
                        "criterion": "adenocarcinoma",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathological"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Arm A: never received systemic anti-tumor drug therapy before, with HER2 negative and PD-L1 CPS≥5; Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines);",
                "criterions": [
                    {
                        "exact_snippets": "Arm A: never received systemic anti-tumor drug therapy before",
                        "criterion": "systemic anti-tumor drug therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Arm A: ... HER2 negative",
                        "criterion": "HER2 status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "Arm A: ... PD-L1 CPS≥5",
                        "criterion": "PD-L1 CPS",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines)",
                        "criterion": "systemic anti-tumor therapy",
                        "requirement": {
                            "requirement_type": "failure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines)",
                        "criterion": "systemic anti-tumor therapy",
                        "requirement": {
                            "requirement_type": "lines",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "xor_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Arm A: never received systemic anti-tumor drug therapy before",
                                "criterion": "systemic anti-tumor drug therapy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Arm A: ... HER2 negative",
                                "criterion": "HER2 status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "negative"
                                }
                            },
                            {
                                "exact_snippets": "Arm A: ... PD-L1 CPS≥5",
                                "criterion": "PD-L1 CPS",
                                "requirement": {
                                    "requirement_type": "score",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "N/A"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines)",
                                "criterion": "systemic anti-tumor therapy",
                                "requirement": {
                                    "requirement_type": "failure",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Arm B: failed to prior systemic anti-tumor therapy (at least 2 lines)",
                                "criterion": "systemic anti-tumor therapy",
                                "requirement": {
                                    "requirement_type": "lines",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "lines"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Measurable lesion according to RECIST v1.1 by IRRC;",
                "criterions": [
                    {
                        "exact_snippets": "Measurable lesion according to RECIST v1.1",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST v1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable lesion according to RECIST v1.1",
                        "criterion": "lesion",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST v1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. ECOG score 0-1;",
                "criterions": [
                    {
                        "exact_snippets": "ECOG score 0-1",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG score 0-1",
                        "criterion": "ECOG score",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Expected survival 12 weeks.",
                "criterions": [
                    {
                        "exact_snippets": "Expected survival 12 weeks.",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Expected survival 12 weeks.",
                        "criterion": "expected survival",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have maximum age of 75 Years",
                "criterions": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "maximum age of 75 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "2. Plan to or have previously received organ or bone marrow transplantation;",
                "criterions": [
                    {
                        "exact_snippets": "Plan to or have previously received organ or bone marrow transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Plan to or have previously received organ or bone marrow transplantation",
                        "criterion": "bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Plan to or have previously received organ or bone marrow transplantation",
                        "criterion": "organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Plan to or have previously received organ or bone marrow transplantation",
                        "criterion": "bone marrow transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrollable pleural effusion",
                        "criterion": "pleural effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrollable ... pericardial effusion",
                        "criterion": "pericardial effusion",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrollable ... ascites requiring repeated drainage",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrollable"
                        }
                    },
                    {
                        "exact_snippets": "Uncontrollable ... ascites requiring repeated drainage",
                        "criterion": "ascites",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "repeated drainage"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrollable pleural effusion",
                                "criterion": "pleural effusion",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrollable"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrollable ... pericardial effusion",
                                "criterion": "pericardial effusion",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrollable"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrollable ... ascites requiring repeated drainage",
                                "criterion": "ascites",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrollable"
                                }
                            },
                            {
                                "exact_snippets": "Uncontrollable ... ascites requiring repeated drainage",
                                "criterion": "ascites",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "repeated drainage"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.) and / or antibody drugs against EGFR; Arm B: previously received antibody drug treatment against EGFR;",
                "criterions": [
                    {
                        "exact_snippets": "Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.)",
                        "criterion": "previous treatment with immune checkpoint inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Arm A: ... and / or antibody drugs against EGFR",
                        "criterion": "previous treatment with EGFR inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Arm B: previously received antibody drug treatment against EGFR",
                        "criterion": "previous treatment with EGFR inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Arm A: previously received antibody drugs against immune checkpoints (such as PD-1, PD-L1, CTLA4, etc.)",
                                        "criterion": "previous treatment with immune checkpoint inhibitors",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Arm A: ... and / or antibody drugs against EGFR",
                                        "criterion": "previous treatment with EGFR inhibitors",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Arm A: ... and / or antibody drugs against EGFR",
                                "criterion": "previous treatment with EGFR inhibitors",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Arm B: previously received antibody drug treatment against EGFR",
                        "criterion": "previous treatment with EGFR inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Have received any research drugs within 14 days before the first use of the study drugs.",
                "criterions": [
                    {
                        "exact_snippets": "Have received any research drugs within 14 days before the first use of the study drugs.",
                        "criterion": "research drugs",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Have received any research drugs within 14 days before the first use of the study drugs.",
                        "criterion": "research drugs",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "2. Age ≥ 18 years and ≤ 75 years when ICF is signed;",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years and ≤ 75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age \u001e 18 years and \u001f 75 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Has other active malignancies within 5 years before the first administration of the study drug;",
                "criterions": [
                    {
                        "exact_snippets": "Has other active malignancies within 5 years before the first administration of the study drug",
                        "criterion": "other active malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Has other active malignancies within 5 years before the first administration of the study drug",
                        "criterion": "other active malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 5 years before the first administration of the study drug"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has other active malignancies within 5 years before the first administration of the study drug",
                        "criterion": "other active malignancies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has other active malignancies within 5 years before the first administration of the study drug",
                        "criterion": "other active malignancies",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 5 years before the first administration of the study drug"
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}