{
    "info": {
        "nct_id": "NCT02426034",
        "official_title": "Safety and Efficacy of Apatinib in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After Failure of Two or More Lines of Chemotherapy (Ahead-G201): a Prospective, Single-arm, Multicenter, Phase IV Study",
        "inclusion_criteria": "1. Age: 18 to75 years old;\n2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);\n3. Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;\n4. ECOG PS of 0-2;\n5. Major organ function has to meet the following criteria:\n\n   For results of blood routine test (without blood transfusion within 14 days):\n\n   HB ≥ 90g / L ANC ≥ 1.5 × 109 / L PLT ≥ 80 × 109 / L\n\n   Biochemical tests results:\n\n   Bilirubin <1.25 times the upper limit of normal (ULN) ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)\n6. An expected survival of ≥ 3 months;\n7. Patient received apatinib treatment regimen at investigators' discretion;\n8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;\n9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Subjects with uncontrolled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), as well as Grade ≥ 2 cardiac dysfunction;\n2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);\n3. Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding;\n4. Abnormal coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleeding;\n5. Presence of central nervous system metastases;\n6. Pregnant or lactating women;\n7. Other conditions regimented at investigators' discretion.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age: 18 to75 years old;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age: 18 to75 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            },
                            {
                                "operator": "<=",
                                "value": 75
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pathologically diagnosed with advanced gastric cancer"
                    ],
                    "criterion": "gastric cancer",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "adenocarcinoma of the gastroesophageal junction"
                    ],
                    "criterion": "adenocarcinoma of the gastroesophageal junction",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Failure of prior therapy"
                    ],
                    "criterion": "prior therapy",
                    "requirement_type": "failure",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "patients who have received at least two prior chemotherapy regimens"
                    ],
                    "criterion": "prior chemotherapy regimens",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. ECOG PS of 0-2;",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG PS of 0-2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "5. Major organ function has to meet the following criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Major organ function"
                    ],
                    "criterion": "major organ function",
                    "requirement_type": "condition",
                    "expected_value": "meet criteria"
                }
            ]
        },
        {
            "line": "For results of blood routine test (without blood transfusion within 14 days):",
            "criterions": [
                {
                    "exact_snippets": [
                        "blood routine test"
                    ],
                    "criterion": "blood routine test",
                    "requirement_type": "results",
                    "expected_value": "N/A"
                },
                {
                    "exact_snippets": [
                        "blood transfusion within 14 days"
                    ],
                    "criterion": "blood transfusion",
                    "requirement_type": "time since last",
                    "expected_value": "> 14"
                }
            ]
        },
        {
            "line": "HB ≥ 90g / L ANC ≥ 1.5 × 109 / L PLT ≥ 80 × 109 / L",
            "criterions": [
                {
                    "exact_snippets": [
                        "HB ≥ 90g / L"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 90
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "ANC ≥ 1.5 × 109 / L"
                    ],
                    "criterion": "absolute neutrophil count",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "PLT ≥ 80 × 109 / L"
                    ],
                    "criterion": "platelet count",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 80
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Biochemical tests results:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Biochemical tests results"
                    ],
                    "criterion": "biochemical tests",
                    "requirement_type": "results",
                    "expected_value": "N/A"
                }
            ]
        },
        {
            "line": "Bilirubin <1.25 times the upper limit of normal (ULN) ALT and AST <2.5 × ULN; liver metastases, if any, the ALT and AST<5 × ULN Serum Cr ≤ 1 × ULN endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Bilirubin <1.25 times the upper limit of normal (ULN)"
                    ],
                    "criterion": "bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1.25
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "ALT and AST <2.5 × ULN"
                    ],
                    "criterion": "ALT and AST",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 2.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "liver metastases, if any, the ALT and AST<5 × ULN"
                    ],
                    "criterion": "ALT and AST with liver metastases",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Serum Cr ≤ 1 × ULN"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "endogenous creatinine clearance>50ml/min (Cockcroft-Gault formula)"
                    ],
                    "criterion": "endogenous creatinine clearance",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 50
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "6. An expected survival of ≥ 3 months;",
            "criterions": [
                {
                    "exact_snippets": [
                        "expected survival",
                        "≥ 3 months"
                    ],
                    "criterion": "expected survival",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "7. Patient received apatinib treatment regimen at investigators' discretion;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patient received apatinib treatment regimen"
                    ],
                    "criterion": "apatinib treatment regimen",
                    "requirement_type": "receipt",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;",
            "criterions": [
                {
                    "exact_snippets": [
                        "voluntarily join the study"
                    ],
                    "criterion": "study participation",
                    "requirement_type": "voluntariness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sign the Informed Consent Form"
                    ],
                    "criterion": "Informed Consent Form",
                    "requirement_type": "signature",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnancy test (serum or urine) has to be performed for woman of childbearing age"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "performance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "the test result must be negative"
                    ],
                    "criterion": "pregnancy test result",
                    "requirement_type": "value",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "woman of childbearing age"
                    ],
                    "criterion": "woman of childbearing age",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 7 days before enrolment"
                    ],
                    "criterion": "pregnancy test timing",
                    "requirement_type": "timing",
                    "expected_value": "within 7 days before enrolment"
                },
                {
                    "exact_snippets": [
                        "They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug"
                    ],
                    "criterion": "contraception for men",
                    "requirement_type": "agreement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 75 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 75
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Subjects with uncontrolled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), as well as Grade ≥ 2 cardiac dysfunction;",
            "criterions": [
                {
                    "exact_snippets": [
                        "uncontrolled arterial hypertension"
                    ],
                    "criterion": "arterial hypertension",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "systolic blood pressure> 140 mmHg"
                    ],
                    "criterion": "systolic blood pressure",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 140
                    }
                },
                {
                    "exact_snippets": [
                        "diastolic blood pressure > 90 mm Hg"
                    ],
                    "criterion": "diastolic blood pressure",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 90
                    }
                },
                {
                    "exact_snippets": [
                        "Grade ≥ 2 coronary heart disease"
                    ],
                    "criterion": "coronary heart disease",
                    "requirement_type": "grade",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2
                    }
                },
                {
                    "exact_snippets": [
                        "Grade ≥ 2 arrhythmia"
                    ],
                    "criterion": "arrhythmia",
                    "requirement_type": "grade",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2
                    }
                },
                {
                    "exact_snippets": [
                        "QT interval prolongation",
                        "for man > 450 ms"
                    ],
                    "criterion": "QT interval",
                    "requirement_type": "prolongation",
                    "expected_value": {
                        "operator": ">",
                        "value": 450
                    }
                },
                {
                    "exact_snippets": [
                        "QT interval prolongation",
                        "for woman > 470 ms"
                    ],
                    "criterion": "QT interval",
                    "requirement_type": "prolongation",
                    "expected_value": {
                        "operator": ">",
                        "value": 470
                    }
                },
                {
                    "exact_snippets": [
                        "Grade ≥ 2 cardiac dysfunction"
                    ],
                    "criterion": "cardiac dysfunction",
                    "requirement_type": "grade",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2
                    }
                }
            ]
        },
        {
            "line": "2. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);",
            "criterions": [
                {
                    "exact_snippets": [
                        "inability to swallow"
                    ],
                    "criterion": "swallowing ability",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "chronic diarrhea"
                    ],
                    "criterion": "chronic diarrhea",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "intestinal obstruction"
                    ],
                    "criterion": "intestinal obstruction",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "3. Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding;",
            "criterions": [
                {
                    "exact_snippets": [
                        "high gastrointestinal bleeding risk"
                    ],
                    "criterion": "gastrointestinal bleeding risk",
                    "requirement_type": "severity",
                    "expected_value": "high"
                },
                {
                    "exact_snippets": [
                        "presence of active ulceration"
                    ],
                    "criterion": "active ulceration",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "positive fecal occult blood test (++)"
                    ],
                    "criterion": "fecal occult blood test",
                    "requirement_type": "result",
                    "expected_value": "positive (++)"
                },
                {
                    "exact_snippets": [
                        "history of hematemesis and melena within three months before enrollment"
                    ],
                    "criterion": "hematemesis and melena",
                    "requirement_type": "history",
                    "expected_value": "within three months before enrollment"
                },
                {
                    "exact_snippets": [
                        "unresected primary lesion in stomach"
                    ],
                    "criterion": "unresected primary lesion in stomach",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "positive fecal occult blood test (+)"
                    ],
                    "criterion": "fecal occult blood test",
                    "requirement_type": "result",
                    "expected_value": "positive (+)"
                },
                {
                    "exact_snippets": [
                        "ulcerated gastric carcinoma"
                    ],
                    "criterion": "ulcerated gastric carcinoma",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding"
                    ],
                    "criterion": "alimentary tract bleeding risk",
                    "requirement_type": "severity",
                    "expected_value": "massive"
                }
            ]
        },
        {
            "line": "4. Abnormal coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleeding;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Abnormal coagulation"
                    ],
                    "criterion": "coagulation",
                    "requirement_type": "normality",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "INR>1.5"
                    ],
                    "criterion": "INR",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "APTT>1.5 UNL"
                    ],
                    "criterion": "APTT",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "tendency of bleeding"
                    ],
                    "criterion": "bleeding tendency",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. Presence of central nervous system metastases;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Presence of central nervous system metastases"
                    ],
                    "criterion": "central nervous system metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. Pregnant or lactating women;",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "7. Other conditions regimented at investigators' discretion.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Other conditions"
                    ],
                    "criterion": "other conditions",
                    "requirement_type": "regimentation",
                    "expected_value": "investigators' discretion"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}