{
"info": {
"nct_id": "NCT03300765",
"official_title": "Intensity Modulated Radiation Therapy Combined With Apatinib for Inoperable or Iodine Refractory Thyroid Cancer: A Phase II Single-arm Study",
"inclusion_criteria": "* Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;\n* Aged ≥ 18 years old;\n* Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to RECIST 1.1);\n* ECOG0-2;\n* Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N ≥ 1500/mm^3; PLT ≥ 80,000/mm^3; HB≥90g/L;total bilirubin < 1.25ULN; AST/ALT < 2.5 ULN or < 5 ULN with metastasis; SCr ≤1ULN; CCR > 50ml/min;\n* The survival period is expected to be greater than 3 months;\n* Willing to accept adequate contraception for patients with childbearing potential.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;\n* Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;\n* Allergic to apainib;\n* Uncontrolled high blood pressure and heart disease;\n* Patients with gastrointestinal bleeding risk;\n* Coagulation disorders(INR>1.5×ULNAPTT>1.5×ULN);\n* Uroprotein positive (Uroprotein≥2+ or 24-hour urinary protein quantity >1.0g);\n* Pregnant or lactating women.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Ability to understand character and individual consequences of the clinical trial. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;",
"criterions": [
{
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"criterion": "understanding of trial consequences",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Willing to sign the written informed consent",
"criterion": "willingness to sign informed consent",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "Informed consent must be signed before the enrollment in the trial",
"criterion": "informed consent signed",
"requirement": {
"requirement_type": "timing",
"expected_value": "before enrollment"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
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"requirement_type": "ability",
"expected_value": true
}
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}
}
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"identified_line": {
"line": "* Aged ≥ 18 years old;",
"criterions": [
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"exact_snippets": "Aged ≥ 18 years old;",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
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}
}
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},
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"and_criteria": [
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"exact_snippets": "Aged ≥ 18 years old;",
"criterion": "age",
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"operator": ">=",
"value": 18,
"unit": "years"
}
}
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},
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"identified_line": {
"line": "* Pathologically confirmed inoperable or iodine refractory thyroid cancer, or postoperative residual disease detected by imaging studies, or progression disease within 12 months before enrollment. (all with measurable disease ≥10mm according to RECIST 1.1);",
"criterions": [
{
"exact_snippets": "Pathologically confirmed inoperable or iodine refractory thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "pathologically confirmed"
}
},
{
"exact_snippets": "Pathologically confirmed inoperable or iodine refractory thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "operability",
"expected_value": "inoperable"
}
},
{
"exact_snippets": "Pathologically confirmed inoperable or iodine refractory thyroid cancer",
"criterion": "thyroid cancer",
"requirement": {
"requirement_type": "iodine refractoriness",
"expected_value": true
}
},
{
"exact_snippets": "postoperative residual disease detected by imaging studies",
"criterion": "postoperative residual disease",
"requirement": {
"requirement_type": "detection",
"expected_value": "imaging studies"
}
},
{
"exact_snippets": "progression disease within 12 months before enrollment",
"criterion": "progression disease",
"requirement": {
"requirement_type": "time frame",
"expected_value": "within 12 months before enrollment"
}
},
{
"exact_snippets": "measurable disease ≥10mm according to RECIST 1.1",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
},
{
"exact_snippets": "measurable disease ≥10mm according to RECIST 1.1",
"criterion": "measurable disease",
"requirement": {
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"expected_value": "RECIST 1.1"
}
}
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},
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"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Pathologically confirmed inoperable or iodine refractory thyroid cancer",
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}
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{
"exact_snippets": "Pathologically confirmed inoperable or iodine refractory thyroid cancer",
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}
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"exact_snippets": "Pathologically confirmed inoperable or iodine refractory thyroid cancer",
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"expected_value": true
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"exact_snippets": "progression disease within 12 months before enrollment",
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"and_criteria": [
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"unit": "mm"
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},
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"exact_snippets": "measurable disease ≥10mm according to RECIST 1.1",
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}
}
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}
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"identified_line": {
"line": "* ECOG0-2;",
"criterions": [
{
"exact_snippets": "ECOG0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
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},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "ECOG0-2",
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"requirement": {
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"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* The survival period is expected to be greater than 3 months;",
"criterions": [
{
"exact_snippets": "The survival period is expected to be greater than 3 months",
"criterion": "survival period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "The survival period is expected to be greater than 3 months",
"criterion": "survival period",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Willing to accept adequate contraception for patients with childbearing potential.",
"criterions": [
{
"exact_snippets": "Willing to accept adequate contraception",
"criterion": "contraception acceptance",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
{
"exact_snippets": "patients with childbearing potential",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"condition": {
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}
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"then_criteria": {
"exact_snippets": "Willing to accept adequate contraception",
"criterion": "contraception acceptance",
"requirement": {
"requirement_type": "willingness",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
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"exact_snippets": "Healthy volunteers allowed",
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"expected_value": "healthy"
}
}
]
},
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"exact_snippets": "Healthy volunteers allowed",
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}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "minimum age of 18 Years",
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"unit": "Years"
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"exact_snippets": "minimum age of 18 Years",
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"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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"value": 80,
"unit": "Years"
}
}
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]
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"exact_snippets": "maximum age of 80 Years",
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"value": 80,
"unit": "Years"
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],
"exclusion_lines": [
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"line": "* Take chemotherapeutic chemotherapy (the use of low-dose chemotherapy for radiosensitization was allowed) or thalidomide and its derivative treatments;",
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"expected_value": true
}
},
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"exact_snippets": "thalidomide and its derivative treatments",
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"expected_value": true
}
}
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"exact_snippets": "Take chemotherapeutic chemotherapy",
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}
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},
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"identified_line": {
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"criterions": [
{
"exact_snippets": "Allergic to apainib",
"criterion": "allergy",
"requirement": {
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"expected_value": "apainib"
}
}
]
},
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"exact_snippets": "Allergic to apainib",
"criterion": "allergy",
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"expected_value": "apainib"
}
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"exact_snippets": "Uncontrolled high blood pressure",
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"expected_value": false
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}
},
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"exact_snippets": "heart disease",
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}
}
]
}
},
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"exact_snippets": "gastrointestinal bleeding risk",
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"expected_value": true
}
}
]
},
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"exact_snippets": "gastrointestinal bleeding risk",
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Coagulation disorders(INR>1.5×ULNAPTT>1.5×ULN);",
"criterions": [
{
"exact_snippets": "Coagulation disorders(INR>1.5×ULN",
"criterion": "INR",
"requirement": {
"requirement_type": "value",
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"operator": ">",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "Coagulation disorders(...APTT>1.5×ULN)",
"criterion": "APTT",
"requirement": {
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"operator": ">",
"value": 1.5,
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}
}
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"exact_snippets": "Coagulation disorders(INR>1.5×ULN",
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"operator": ">",
"value": 1.5,
"unit": "ULN"
}
}
},
{
"exact_snippets": "Coagulation disorders(...APTT>1.5×ULN)",
"criterion": "APTT",
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"operator": ">",
"value": 1.5,
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}
}
}
]
}
},
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"identified_line": {
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"criterions": [
{
"exact_snippets": "Uroprotein positive (Uroprotein≥2+",
"criterion": "Uroprotein",
"requirement": {
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"expected_value": "positive"
}
},
{
"exact_snippets": "Uroprotein positive (Uroprotein≥2+",
"criterion": "Uroprotein",
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "+"
}
}
},
{
"exact_snippets": "24-hour urinary protein quantity >1.0g",
"criterion": "24-hour urinary protein quantity",
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"operator": ">",
"value": 1.0,
"unit": "g"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Uroprotein positive (Uroprotein≥2+",
"criterion": "Uroprotein",
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"requirement_type": "presence",
"expected_value": "positive"
}
},
{
"exact_snippets": "Uroprotein positive (Uroprotein≥2+",
"criterion": "Uroprotein",
"requirement": {
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"operator": ">=",
"value": 2,
"unit": "+"
}
}
}
]
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"exact_snippets": "24-hour urinary protein quantity >1.0g",
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"expected_value": {
"operator": ">",
"value": 1.0,
"unit": "g"
}
}
}
]
}
},
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"identified_line": {
"line": "* Pregnant or lactating women.",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
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"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
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"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
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"expected_value": false
}
},
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"exact_snippets": "lactating women",
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"expected_value": false
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Adequate laboratory values within 14 dyas of enrollment to study defined as follows: N ≥ 1500/mm^3; PLT ≥ 80,000/mm^3; HB≥90g/L;total bilirubin < 1.25ULN; AST/ALT < 2.5 ULN or < 5 ULN with metastasis; SCr ≤1ULN; CCR > 50ml/min;",
"criterions": [
{
"exact_snippets": "N ≥ 1500/mm^3",
"criterion": "neutrophil count",
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"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
},
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"exact_snippets": "PLT ≥ 80,000/mm^3",
"criterion": "platelet count",
"requirement": {
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"operator": ">=",
"value": 80000,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "HB≥90g/L",
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"operator": ">=",
"value": 90,
"unit": "g/L"
}
}
},
{
"exact_snippets": "total bilirubin < 1.25ULN",
"criterion": "total bilirubin level",
"requirement": {
"requirement_type": "quantity",
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"operator": "<",
"value": 1.25,
"unit": "ULN"
}
}
},
{
"exact_snippets": "AST/ALT < 2.5 ULN or < 5 ULN with metastasis",
"criterion": "AST/ALT levels",
"requirement": {
"requirement_type": "quantity",
"expected_value": [
"> 2.5 ULN",
"< 5 ULN with metastasis"
]
}
},
{
"exact_snippets": "SCr ≤1ULN",
"criterion": "serum creatinine level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
},
{
"exact_snippets": "CCR > 50ml/min",
"criterion": "creatinine clearance rate",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "ml/min"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "N ≥ 1500/mm^3",
"criterion": "neutrophil count",
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"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "PLT ≥ 80,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 80000,
"unit": "mm^3"
}
}
}
]
},
{
"exact_snippets": "HB≥90g/L",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "g/L"
}
}
}
]
},
{
"exact_snippets": "total bilirubin < 1.25ULN",
"criterion": "total bilirubin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 1.25,
"unit": "ULN"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "AST/ALT < 2.5 ULN or < 5 ULN with metastasis",
"criterion": "AST/ALT levels",
"requirement": {
"requirement_type": "quantity",
"expected_value": "< 2.5 ULN"
}
},
{
"exact_snippets": "AST/ALT < 2.5 ULN or < 5 ULN with metastasis",
"criterion": "AST/ALT levels",
"requirement": {
"requirement_type": "quantity",
"expected_value": "< 5 ULN with metastasis"
}
}
]
}
]
},
{
"exact_snippets": "SCr ≤1ULN",
"criterion": "serum creatinine level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "ULN"
}
}
}
]
},
{
"exact_snippets": "CCR > 50ml/min",
"criterion": "creatinine clearance rate",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 50,
"unit": "ml/min"
}
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Take VEGFR-TKI within 1 month, such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib;",
"criterions": [
{
"exact_snippets": "Take VEGFR-TKI within 1 month",
"criterion": "VEGFR-TKI intake",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
},
{
"exact_snippets": "such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib",
"criterion": "specific VEGFR-TKI drugs",
"requirement": {
"requirement_type": "drug names",
"expected_value": [
"vandetanib",
"cabozantinib",
"lenvatinib",
"sunitinib",
"sorafenib"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Take VEGFR-TKI within 1 month",
"criterion": "VEGFR-TKI intake",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
},
{
"or_criteria": [
{
"exact_snippets": "such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib",
"criterion": "specific VEGFR-TKI drugs",
"requirement": {
"requirement_type": "drug names",
"expected_value": "vandetanib"
}
},
{
"exact_snippets": "such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib",
"criterion": "specific VEGFR-TKI drugs",
"requirement": {
"requirement_type": "drug names",
"expected_value": "cabozantinib"
}
},
{
"exact_snippets": "such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib",
"criterion": "specific VEGFR-TKI drugs",
"requirement": {
"requirement_type": "drug names",
"expected_value": "lenvatinib"
}
},
{
"exact_snippets": "such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib",
"criterion": "specific VEGFR-TKI drugs",
"requirement": {
"requirement_type": "drug names",
"expected_value": "sunitinib"
}
},
{
"exact_snippets": "such as vandetanib, cabozantinib, lenvatinib, sunitinib and sorafenib",
"criterion": "specific VEGFR-TKI drugs",
"requirement": {
"requirement_type": "drug names",
"expected_value": "sorafenib"
}
}
]
}
]
}
]
}
}
],
"failed_miscellaneous": []
}