{
"info": {
"nct_id": "NCT02951091",
"official_title": "The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer",
"inclusion_criteria": "1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer\n2. Eastern Cooperative Oncology Group performance status of 0 to 1\n3. Male or female; ≥ 19 years of age\n4. On or progression after 1st line palliative chemotherapy\n5. Subjects with evaluable lesion (using RECIST 1.1 criteria)\n6. Subjects who meet the following criteria:\n\n * Absolute neutrophil count ≥ 1000 /µL\n * Platelet count ≥ 75,000/ µL\n * Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min\n * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
"exclusion_criteria": "* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed",
"criterion": "confirmation method",
"requirements": [
{
"requirement_type": "method",
"expected_value": [
"histologically",
"cytologically"
]
}
]
},
{
"exact_snippets": "locally advanced or metastatic gastric cancer",
"criterion": "gastric cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": [
"locally advanced",
"metastatic"
]
}
]
},
{
"exact_snippets": "gastroesophageal junction cancer",
"criterion": "cancer type",
"requirements": [
{
"requirement_type": "type",
"expected_value": "gastroesophageal junction cancer"
}
]
}
]
},
{
"line": "2. Eastern Cooperative Oncology Group performance status of 0 to 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group performance status of 0 to 1",
"criterion": "Eastern Cooperative Oncology Group performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "3. Male or female; ≥ 19 years of age",
"criterions": [
{
"exact_snippets": "Male or female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "≥ 19 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 19,
"unit": "years"
}
}
]
}
]
},
{
"line": "4. On or progression after 1st line palliative chemotherapy",
"criterions": [
{
"exact_snippets": "progression after 1st line palliative chemotherapy",
"criterion": "progression after chemotherapy",
"requirements": [
{
"requirement_type": "treatment line",
"expected_value": "1st line"
},
{
"requirement_type": "treatment type",
"expected_value": "palliative"
}
]
}
]
},
{
"line": "5. Subjects with evaluable lesion (using RECIST 1.1 criteria)",
"criterions": [
{
"exact_snippets": "evaluable lesion (using RECIST 1.1 criteria)",
"criterion": "evaluable lesion",
"requirements": [
{
"requirement_type": "evaluation criteria",
"expected_value": "RECIST 1.1"
}
]
}
]
},
{
"line": "* Absolute neutrophil count ≥ 1000 /µL",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count ≥ 1000 /µL",
"criterion": "absolute neutrophil count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000,
"unit": "/µL"
}
}
]
}
]
},
{
"line": "* Platelet count ≥ 75,000/ µL",
"criterions": [
{
"exact_snippets": "Platelet count ≥ 75,000/ µL",
"criterion": "platelet count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 75000,
"unit": "/ µL"
}
}
]
}
]
},
{
"line": "* Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min",
"criterions": [
{
"exact_snippets": "Serum creatinine < 1.5 x upper limit of normal",
"criterion": "serum creatinine",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "x upper limit of normal"
}
}
]
},
{
"exact_snippets": "Creatinine clearance ≥60 mL/min",
"criterion": "creatinine clearance",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "mL/min"
}
}
]
}
]
},
{
"line": "* aspartate aminotransferase and alanine transaminase 3 x upper limit of normal",
"criterions": [
{
"exact_snippets": "aspartate aminotransferase ... 3 x upper limit of normal",
"criterion": "aspartate aminotransferase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x upper limit of normal"
}
}
]
},
{
"exact_snippets": "alanine transaminase 3 x upper limit of normal",
"criterion": "alanine transaminase",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "x upper limit of normal"
}
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 19 Years",
"criterions": [
{
"exact_snippets": "minimum age of 19 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 19,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study",
"criterions": [
{
"exact_snippets": "Evidence of any other significant clinical disorder",
"criterion": "significant clinical disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "laboratory finding that makes it undesirable for the patient to participate",
"criterion": "laboratory finding",
"requirements": [
{
"requirement_type": "undesirability for participation",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "6. Subjects who meet the following criteria:",
"criterions": []
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}