{
"info": {
"nct_id": "NCT03701373",
"official_title": "Maintenance Treatment With S-1 Versus Observation After First-line Chemotherapy in Patients With Advanced Gastric Cancer: a Randomized Phase II Study",
"inclusion_criteria": "* Age older than 18 years\n* Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1\n* At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)\n* Histologically confirmed gastric cancer with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy\n* No previous chemotherapy for metastatic GC was allowed, the interval after the end of adjuvant/neoadjuvant chemotherapy beyond 6 months was allowable\n* Life expectancy of at least 3 months\n* Adequate hematologic, hepatic and renal function. Neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), AST or ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases), alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases); serum creatinine ≤ 1.5 × ULN;and albumin ≥ 25 g/L\n* Patients who achieved objective response or stable disease after 2-6 month first-line chemotherapy\n* The first-line chemotherapy regimens were doublets including platinum (cisplatin or oxaliplatin) plus fluoropyrimidine (5-FU, capecitabine, or S-1)\n* Signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Known hypersensitivity to platinum (cisplatin or oxaliplatin) or fluoropyrimidine (5-FU, capecitabine, or S-1)\n* History or clinical evidence of brain metastases\n* Previous chemotherapy for metastatic disease\n* Positive serum pregnancy test in women of childbearing potential\n* Subjects with reproductive potential not willing to use an effective method of contraception\n* Received any investigational drug treatment within 4 weeks of start of study treatment\n* Other prior malignancies in the past 5 years\n* Unresolved bowel obstruction or malabsorption syndrome",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age older than 18 years",
"criterions": [
{
"exact_snippets": "Age older than 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age older than 18 years",
"criterion": "age",
"requirement": {
"requirement_type": "value",
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"operator": ">",
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"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1",
"criterion": "Eastern Cooperative Oncology Group performance status (ECOG PS)",
"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": "Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1",
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"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
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{
"operator": "<=",
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"unit": "N/A"
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]
}
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}
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}
},
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"identified_line": {
"line": "* At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)",
"criterions": [
{
"exact_snippets": "At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)",
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"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)",
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"requirement": {
"requirement_type": "evaluation criteria",
"expected_value": "RECIST version 1.0"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)",
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"expected_value": {
"operator": ">=",
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"unit": "N/A"
}
}
},
{
"exact_snippets": "At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumor (RECIST version 1.0)",
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}
]
}
},
{
"identified_line": {
"line": "* No previous chemotherapy for metastatic GC was allowed, the interval after the end of adjuvant/neoadjuvant chemotherapy beyond 6 months was allowable",
"criterions": [
{
"exact_snippets": "No previous chemotherapy for metastatic GC was allowed",
"criterion": "previous chemotherapy for metastatic GC",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "the interval after the end of adjuvant/neoadjuvant chemotherapy beyond 6 months was allowable",
"criterion": "interval after adjuvant/neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"not_criteria": {
"exact_snippets": "No previous chemotherapy for metastatic GC was allowed",
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"requirement_type": "presence",
"expected_value": false
}
}
},
{
"exact_snippets": "the interval after the end of adjuvant/neoadjuvant chemotherapy beyond 6 months was allowable",
"criterion": "interval after adjuvant/neoadjuvant chemotherapy",
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"requirement_type": "duration",
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"operator": ">",
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"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy of at least 3 months",
"criterions": [
{
"exact_snippets": "Life expectancy of at least 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy of at least 3 months",
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"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who achieved objective response or stable disease after 2-6 month first-line chemotherapy",
"criterions": [
{
"exact_snippets": "Patients who achieved objective response",
"criterion": "objective response",
"requirement": {
"requirement_type": "achievement",
"expected_value": true
}
},
{
"exact_snippets": "stable disease after 2-6 month first-line chemotherapy",
"criterion": "stable disease",
"requirement": {
"requirement_type": "achievement",
"expected_value": true
}
},
{
"exact_snippets": "2-6 month first-line chemotherapy",
"criterion": "first-line chemotherapy duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "month"
},
{
"operator": "<=",
"value": 6,
"unit": "month"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who achieved objective response",
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"expected_value": true
}
},
{
"exact_snippets": "2-6 month first-line chemotherapy",
"criterion": "first-line chemotherapy duration",
"requirement": {
"requirement_type": "duration",
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"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "month"
},
{
"operator": "<=",
"value": 6,
"unit": "month"
}
]
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "stable disease after 2-6 month first-line chemotherapy",
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"requirement": {
"requirement_type": "achievement",
"expected_value": true
}
},
{
"exact_snippets": "2-6 month first-line chemotherapy",
"criterion": "first-line chemotherapy duration",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "month"
},
{
"operator": "<=",
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"unit": "month"
}
]
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Signed informed consent",
"criterions": [
{
"exact_snippets": "Signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
}
},
{
"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",
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
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"operator": ">=",
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"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
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{
"exact_snippets": "maximum age of 80 Years",
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"operator": "<=",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
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"operator": "<=",
"value": 80,
"unit": "Years"
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}
}
]
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],
"exclusion_lines": [
{
"identified_line": {
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{
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"expected_value": true
}
},
{
"exact_snippets": "Known hypersensitivity to ... fluoropyrimidine (5-FU, capecitabine, or S-1)",
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"requirement": {
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"expected_value": true
}
}
]
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{
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"expected_value": true
}
},
{
"exact_snippets": "Known hypersensitivity to ... fluoropyrimidine (5-FU, capecitabine, or S-1)",
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}
}
]
}
},
{
"identified_line": {
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{
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}
}
]
},
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}
}
}
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{
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}
}
]
},
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}
}
}
},
{
"identified_line": {
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"criterions": [
{
"exact_snippets": "Positive serum pregnancy test",
"criterion": "serum pregnancy test",
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}
},
{
"exact_snippets": "women of childbearing potential",
"criterion": "childbearing potential",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "women of childbearing potential",
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Positive serum pregnancy test",
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}
},
{
"exact_snippets": "women of childbearing potential",
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"requirement": {
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}
},
{
"exact_snippets": "women of childbearing potential",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Subjects with reproductive potential not willing to use an effective method of contraception",
"criterions": [
{
"exact_snippets": "Subjects with reproductive potential",
"criterion": "reproductive potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "not willing to use an effective method of contraception",
"criterion": "willingness to use contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Subjects with reproductive potential",
"criterion": "reproductive potential",
"requirement": {
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"expected_value": true
}
},
{
"not_criteria": {
"exact_snippets": "not willing to use an effective method of contraception",
"criterion": "willingness to use contraception",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
}
}
]
}
},
{
"identified_line": {
"line": "* Received any investigational drug treatment within 4 weeks of start of study treatment",
"criterions": [
{
"exact_snippets": "Received any investigational drug treatment within 4 weeks of start of study treatment",
"criterion": "investigational drug treatment",
"requirement": {
"requirement_type": "time since last treatment",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
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"exact_snippets": "Received any investigational drug treatment within 4 weeks of start of study treatment",
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"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "* Other prior malignancies in the past 5 years",
"criterions": [
{
"exact_snippets": "Other prior malignancies in the past 5 years",
"criterion": "prior malignancies",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
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"exact_snippets": "Other prior malignancies in the past 5 years",
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"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "* Unresolved bowel obstruction or malabsorption syndrome",
"criterions": [
{
"exact_snippets": "Unresolved bowel obstruction",
"criterion": "bowel obstruction",
"requirement": {
"requirement_type": "resolution",
"expected_value": false
}
},
{
"exact_snippets": "malabsorption syndrome",
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"expected_value": true
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "Unresolved bowel obstruction",
"criterion": "bowel obstruction",
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}
},
{
"exact_snippets": "malabsorption syndrome",
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histologically confirmed gastric cancer with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy",
"criterions": [
{
"exact_snippets": "Histologically confirmed gastric cancer",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
},
{
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"expected_value": false
}
},
{
"exact_snippets": "inoperable locally advanced or recurrent and/or metastatic disease",
"criterion": "disease stage",
"requirement": {
"requirement_type": "stage",
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"locally advanced",
"recurrent",
"metastatic"
]
}
},
{
"exact_snippets": "not amenable to curative therapy",
"criterion": "curative therapy eligibility",
"requirement": {
"requirement_type": "eligibility",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed gastric cancer",
"criterion": "gastric cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically confirmed"
}
},
{
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}
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"or_criteria": [
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}
},
{
"exact_snippets": "inoperable locally advanced or recurrent and/or metastatic disease",
"criterion": "disease stage",
"requirement": {
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"expected_value": "recurrent"
}
},
{
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"expected_value": "metastatic"
}
}
]
}
]
},
{
"exact_snippets": "not amenable to curative therapy",
"criterion": "curative therapy eligibility",
"requirement": {
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hematologic, hepatic and renal function. Neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; Serum bilirubin ≤ 1.5 × upper limit of normal (ULN), AST or ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases), alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases); serum creatinine ≤ 1.5 × ULN;and albumin ≥ 25 g/L",
"criterions": [
{
"exact_snippets": "Adequate hematologic ... Neutrophil count ≥ 1.5 × 109/L",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "× 10^9/L"
}
}
},
{
"exact_snippets": "Adequate hematologic ... platelet count ≥ 100 × 109/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "× 10^9/L"
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "× ULN"
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... AST or ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)",
"criterion": "AST or ALT",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2.5,
"unit": "× ULN"
},
{
"operator": "<=",
"value": 5,
"unit": "× ULN"
}
]
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases)",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2.5,
"unit": "× ULN"
},
{
"operator": "<=",
"value": 5,
"unit": "× ULN"
},
{
"operator": "<=",
"value": 10,
"unit": "× ULN"
}
]
}
}
},
{
"exact_snippets": "Adequate ... renal ... serum creatinine ≤ 1.5 × ULN",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "× ULN"
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... albumin ≥ 25 g/L",
"criterion": "albumin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 25,
"unit": "g/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate hematologic ... Neutrophil count ≥ 1.5 × 109/L",
"criterion": "neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "× 10^9/L"
}
}
},
{
"exact_snippets": "Adequate hematologic ... platelet count ≥ 100 × 109/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "× 10^9/L"
}
}
}
]
},
{
"exact_snippets": "Adequate ... hepatic ... Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)",
"criterion": "serum bilirubin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "× ULN"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Adequate ... hepatic ... AST or ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)",
"criterion": "AST or ALT",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2.5,
"unit": "× ULN"
}
]
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... AST or ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)",
"criterion": "AST or ALT",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "× ULN"
}
]
}
}
}
]
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Adequate ... hepatic ... alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases)",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 2.5,
"unit": "× ULN"
}
]
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases)",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "× ULN"
}
]
}
}
},
{
"exact_snippets": "Adequate ... hepatic ... alkaline phosphatase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases, or ≤ 10 × ULN in patients with bone but no liver metastases)",
"criterion": "alkaline phosphatase",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 10,
"unit": "× ULN"
}
]
}
}
}
]
}
]
},
{
"exact_snippets": "Adequate ... renal ... serum creatinine ≤ 1.5 × ULN",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "× ULN"
}
}
}
]
},
{
"exact_snippets": "Adequate ... hepatic ... albumin ≥ 25 g/L",
"criterion": "albumin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 25,
"unit": "g/L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* The first-line chemotherapy regimens were doublets including platinum (cisplatin or oxaliplatin) plus fluoropyrimidine (5-FU, capecitabine, or S-1)",
"criterions": [
{
"exact_snippets": "first-line chemotherapy regimens were doublets including platinum (cisplatin or oxaliplatin) plus fluoropyrimidine (5-FU, capecitabine, or S-1)",
"criterion": "first-line chemotherapy regimen",
"requirement": {
"requirement_type": "composition",
"expected_value": [
"platinum (cisplatin or oxaliplatin)",
"fluoropyrimidine (5-FU, capecitabine, or S-1)"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}