{
    "info": {
        "nct_id": "NCT03271073",
        "official_title": "A Exploratory Study of Apatinib in Combination With S1 in Patients With Advanced Gastric Evaluating the Efficacy and Safety",
        "inclusion_criteria": "1. Adult patients, aged between 18 and 75 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;\n3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;\n4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;\n5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);\n6. Expected survival of ≥ 12 weeks.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;\n2. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;\n3. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;\n4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);\n5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);\n6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;\n7. Associated with CNS (central nervous system) metastases;\n8. Active bacterial infections;\n9. Pregnant or breast-feeding women;\n10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Adult patients, aged between 18 and 75 years old;",
            "criterions": [
                {
                    "exact_snippets": "Adult patients",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "expected value",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged between 18 and 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC) , including adenocarcinoma of the gastroesophageal junction ,one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1;",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)",
                    "criterion": "adenocarcinoma of gastric cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma of the gastroesophageal junction",
                    "criterion": "adenocarcinoma of the gastroesophageal junction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one or more measurable or nonmeasurable evaluable lesions per RECIST 1.1",
                    "criterion": "evaluable lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesions"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "nonmeasurable"
                            ]
                        },
                        {
                            "requirement_type": "evaluation standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Failure or intolerance to at least one prior line of systemic chemotherapy regimen;",
            "criterions": [
                {
                    "exact_snippets": "Failure or intolerance to at least one prior line of systemic chemotherapy regimen",
                    "criterion": "prior systemic chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "failure or intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Adequate liver, renal, heart, and bone-marrow functions ( hemoglobin≥ 80g/L, platelets ≥ 100 × 10*9/L, neutrophil ≥1.5 × 10*9/L, total bilirubin ≤1.5 ×ULN, and serum transaminase≤2.5×ULN);",
            "criterions": [
                {
                    "exact_snippets": "Adequate liver, renal, heart, and bone-marrow functions",
                    "criterion": "liver, renal, heart, and bone-marrow functions",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin≥ 80g/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "g/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelets ≥ 100 × 10*9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "10*9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neutrophil ≥1.5 × 10*9/L",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "10*9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤1.5 ×ULN",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum transaminase≤2.5×ULN",
                    "criterion": "serum transaminase level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Expected survival of ≥ 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Expected survival of ≥ 12 weeks.",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "healthy volunteers",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than ClassI; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;",
            "criterions": [
                {
                    "exact_snippets": "poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg)",
                    "criterion": "arterial hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poor-controlled"
                        },
                        {
                            "requirement_type": "systolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 140,
                                "unit": "mmHg"
                            }
                        },
                        {
                            "requirement_type": "diastolic blood pressure",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mm Hg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Coronary heart disease greater than ClassI",
                    "criterion": "coronary heart disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "> Class I"
                        }
                    ]
                },
                {
                    "exact_snippets": "I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms)",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "I-level"
                        },
                        {
                            "requirement_type": "QT interval prolongation",
                            "expected_value": [
                                ">= 450 ms for man",
                                ">= 470 ms for woman"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Class I cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Class I"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;",
            "criterions": [
                {
                    "exact_snippets": "high gastrointestinal bleeding risk",
                    "criterion": "gastrointestinal bleeding risk",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "local active ulcer lesions",
                    "criterion": "ulcer lesions",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "local"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive fecal occult blood test (++)",
                    "criterion": "fecal occult blood test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of black stool",
                    "criterion": "black stool",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "vomiting blood in the past 2 months",
                    "criterion": "vomiting blood",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;",
            "criterions": [
                {
                    "exact_snippets": "Abnormal Coagulation (INR>1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal Coagulation ... APTT>1.5 UNL",
                    "criterion": "APTT",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tendency of bleed",
                    "criterion": "tendency of bleed",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. 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": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic diarrhea",
                    "criterion": "chronic diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "intestinal obstruction",
                    "criterion": "intestinal obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib);",
            "criterions": [
                {
                    "exact_snippets": "Previous treatment with VEGFR inhibitor (i.e. Apatinib, sorafenib, sunitinib)",
                    "criterion": "previous treatment with VEGFR inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. With psychotropic drug abuse history and can't get rid of or mental disorder patients;",
            "criterions": [
                {
                    "exact_snippets": "psychotropic drug abuse history",
                    "criterion": "psychotropic drug abuse history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can't get rid of",
                    "criterion": "inability to cease psychotropic drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental disorder patients",
                    "criterion": "mental disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Associated with CNS (central nervous system) metastases;",
            "criterions": [
                {
                    "exact_snippets": "Associated with CNS (central nervous system) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Active bacterial infections;",
            "criterions": [
                {
                    "exact_snippets": "Active bacterial infections",
                    "criterion": "bacterial infections",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Pregnant or breast-feeding women;",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Any other condition that might place the patient at undue risk or preclude a patient from completing the study.",
            "criterions": [
                {
                    "exact_snippets": "Any other condition that might place the patient at undue risk",
                    "criterion": "condition causing undue risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "condition that might ... preclude a patient from completing the study",
                    "criterion": "condition precluding study completion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}