{
"info": {
"nct_id": "NCT06192680",
"official_title": "A Multicenter, Single-arm Study of Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer",
"inclusion_criteria": "* Age: ≥18 years old.\n* Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma, and patients failed or are intolerant to first-line treatment with oxaliplatin ± VEGF/EGFR.\n* At least one measurable lesion (according to RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.\n* The expected survival time ≥3 months.\n* Subject has adequate biological parameters as demonstrated by the following: Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin (Hgb) ≥90 g/L.\n* Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present. Serum albumin ≥3 g/dL.\n* Adequate renal function as evidenced by serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. Proteinuria < 2+ (those with proteinuria ≥2+ at baseline had to demonstrate ≤1 g protein per 24 hours).\n* Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Subjects agree to use contraception and are not pregnant or breastfeeding women.\n* Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.\n* Previous treatment with irinotecan/liposomal irinotecan.\n* Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first line.\n* Known as high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).\n* Massive pleural effusion or ascites requiring intervention.\n* Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.\n* Active HIV infection.\n* Combined with uncontrollable systemic diseases within 6 months before the first administration.\n* Presence of severe gastrointestinal disease.\n* History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration, or plan to undergo major surgery during the study period.\n* Presence of interstitial pneumonia or pulmonary fibrosis.\n* History of allergy or hypersensitivity to drug or any of their excipients.\n* History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration.\n* Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration.\n* Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome.\n* Use of strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1 within 14 days before the first administration.\n* Use other study drug within 1 month before the first administration.\n* Patients who are not suitable to participate in this trial for any reason judged by the investigator.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age: ≥18 years old.",
"criterions": [
{
"exact_snippets": "Age: ≥18 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age: ≥18 years old.",
"criterion": "age",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* At least one measurable lesion (according to RECIST v1.1).",
"criterions": [
{
"exact_snippets": "At least one measurable lesion (according to RECIST v1.1)",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "At least one measurable lesion (according to RECIST v1.1)",
"criterion": "measurable lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.",
"criterion": "ECOG performance status",
"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 (ECOG) performance status of 0 ~ 1.",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* The expected survival time ≥3 months.",
"criterions": [
{
"exact_snippets": "expected survival time ≥3 months",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "expected survival time ≥3 months",
"criterion": "expected survival time",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Subject has adequate biological parameters as demonstrated by the following: Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin (Hgb) ≥90 g/L.",
"criterions": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥1.5×10^9/L",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "10^9/L"
}
}
},
{
"exact_snippets": "Platelet count ≥100×10^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "10^9/L"
}
}
},
{
"exact_snippets": "Hemoglobin (Hgb) ≥90 g/L",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "g/L"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute neutrophil count (ANC) ≥1.5×10^9/L",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1.5,
"unit": "10^9/L"
}
}
},
{
"exact_snippets": "Platelet count ≥100×10^9/L",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100,
"unit": "10^9/L"
}
}
},
{
"exact_snippets": "Hemoglobin (Hgb) ≥90 g/L",
"criterion": "hemoglobin",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 90,
"unit": "g/L"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN.",
"criterions": [
{
"exact_snippets": "Coagulation function: International normalised ratio (INR) ≤1.5",
"criterion": "International normalised ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Coagulation function: ... activated partial thromboplastin time (APTT) ≤1.5 × ULN",
"criterion": "activated partial thromboplastin time (APTT)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "× ULN"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Coagulation function: International normalised ratio (INR) ≤1.5",
"criterion": "International normalised ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Coagulation function: ... activated partial thromboplastin time (APTT) ≤1.5 × ULN",
"criterion": "activated partial thromboplastin time (APTT)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "× ULN"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Left ventricular ejection fraction (LVEF) ≥50%.",
"criterions": [
{
"exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Left ventricular ejection fraction (LVEF) ≥50%",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Subjects agree to use contraception and are not pregnant or breastfeeding women.",
"criterions": [
{
"exact_snippets": "Subjects agree to use contraception",
"criterion": "contraception use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "not pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "not ... breastfeeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Subjects agree to use contraception",
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"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "not pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
},
{
"exact_snippets": "not ... breastfeeding women",
"criterion": "breastfeeding",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.",
"criterions": [
{
"exact_snippets": "Agree and be able to comply with the plan during the study period.",
"criterion": "compliance with study plan",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Provide written informed consent before entering the study screening.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "Agree and be able to comply with the plan during the study period.",
"criterion": "compliance with study plan",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
},
{
"exact_snippets": "Provide written informed consent before entering the study screening.",
"criterion": "informed consent",
"requirement": {
"requirement_type": "provision",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
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"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Active HIV infection.",
"criterions": [
{
"exact_snippets": "Active HIV infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Active HIV infection",
"criterion": "HIV infection",
"requirement": {
"requirement_type": "status",
"expected_value": "active"
}
}
]
}
},
{
"identified_line": {
"line": "* Combined with uncontrollable systemic diseases within 6 months before the first administration.",
"criterions": [
{
"exact_snippets": "uncontrollable systemic diseases",
"criterion": "systemic diseases",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrollable"
}
},
{
"exact_snippets": "within 6 months before the first administration",
"criterion": "time since diagnosis or control",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "uncontrollable systemic diseases",
"criterion": "systemic diseases",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrollable"
}
},
{
"exact_snippets": "within 6 months before the first administration",
"criterion": "time since diagnosis or control",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Presence of severe gastrointestinal disease.",
"criterions": [
{
"exact_snippets": "Presence of severe gastrointestinal disease",
"criterion": "gastrointestinal disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Presence of severe gastrointestinal disease",
"criterion": "gastrointestinal disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Presence of severe gastrointestinal disease",
"criterion": "gastrointestinal disease",
"requirement": {
"requirement_type": "severity",
"expected_value": "severe"
}
},
{
"exact_snippets": "Presence of severe gastrointestinal disease",
"criterion": "gastrointestinal disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration, or plan to undergo major surgery during the study period.",
"criterions": [
{
"exact_snippets": "History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration",
"criterion": "history of major surgery",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
},
{
"exact_snippets": "plan to undergo major surgery during the study period",
"criterion": "plan to undergo major surgery",
"requirement": {
"requirement_type": "time frame",
"expected_value": "during the study period"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration",
"criterion": "history of major surgery",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<",
"value": 28,
"unit": "days"
}
}
}
]
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"and_criteria": [
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"exact_snippets": "plan to undergo major surgery during the study period",
"criterion": "plan to undergo major surgery",
"requirement": {
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"expected_value": "during the study period"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Presence of interstitial pneumonia or pulmonary fibrosis.",
"criterions": [
{
"exact_snippets": "Presence of interstitial pneumonia",
"criterion": "interstitial pneumonia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of ... pulmonary fibrosis",
"criterion": "pulmonary fibrosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"or_criteria": [
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"exact_snippets": "Presence of interstitial pneumonia",
"criterion": "interstitial pneumonia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Presence of ... pulmonary fibrosis",
"criterion": "pulmonary fibrosis",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of allergy or hypersensitivity to drug or any of their excipients.",
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{
"exact_snippets": "History of allergy or hypersensitivity to drug",
"criterion": "allergy or hypersensitivity",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "allergy or hypersensitivity to ... any of their excipients",
"criterion": "allergy or hypersensitivity to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
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"exact_snippets": "History of allergy or hypersensitivity to drug",
"criterion": "allergy or hypersensitivity",
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"expected_value": false
}
},
{
"exact_snippets": "allergy or hypersensitivity to ... any of their excipients",
"criterion": "allergy or hypersensitivity to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration.",
"criterions": [
{
"exact_snippets": "History of pulmonary hemorrhage/hemoptysis",
"criterion": "pulmonary hemorrhage/hemoptysis",
"requirement": {
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"expected_value": true
}
},
{
"exact_snippets": "≥Grade 2 (defined as bright red blood of at least 2.5mL)",
"criterion": "pulmonary hemorrhage/hemoptysis severity",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "Grade"
}
}
},
{
"exact_snippets": "within one month before the first administration",
"criterion": "time since last pulmonary hemorrhage/hemoptysis",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
},
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History of pulmonary hemorrhage/hemoptysis",
"criterion": "pulmonary hemorrhage/hemoptysis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "≥Grade 2 (defined as bright red blood of at least 2.5mL)",
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"requirement": {
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"expected_value": {
"operator": ">=",
"value": 2,
"unit": "Grade"
}
}
}
]
},
{
"exact_snippets": "within one month before the first administration",
"criterion": "time since last pulmonary hemorrhage/hemoptysis",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": "<=",
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"unit": "month"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration.",
"criterions": [
{
"exact_snippets": "Presence of arterial embolism",
"criterion": "arterial embolism",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "severe bleeding (excluding bleeding caused by surgery)",
"criterion": "severe bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "tendency for existing embolism",
"criterion": "tendency for existing embolism",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "tendency for ... severe bleeding",
"criterion": "tendency for severe bleeding",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "within 6 months before the first administration",
"criterion": "time since last event",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Presence of arterial embolism",
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"requirement_type": "presence",
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}
},
{
"exact_snippets": "within 6 months before the first administration",
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"requirement_type": "time frame",
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"operator": "<=",
"value": 6,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "severe bleeding (excluding bleeding caused by surgery)",
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"requirement_type": "presence",
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}
},
{
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"operator": "<=",
"value": 6,
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}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "tendency for existing embolism",
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"requirement_type": "presence",
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},
{
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}
}
]
},
{
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{
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},
{
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"value": 6,
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}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome.",
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{
"exact_snippets": "symptomatic brain metastasis",
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},
{
"exact_snippets": "meningeal metastasis",
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"requirement_type": "presence",
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},
{
"exact_snippets": "spinal cord tumor invasion",
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"requirement_type": "presence",
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},
{
"exact_snippets": "spinal cord compression syndrome",
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]
},
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{
"and_criteria": [
{
"exact_snippets": "symptomatic brain metastasis",
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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": {
"line": "* Use of strong inhibitors or inducers of CYP3A4, CYP2C8 and UGT1A1 within 14 days before the first administration.",
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{
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]
},
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"identified_line": {
"line": "* Use other study drug within 1 month before the first administration.",
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"operator": "<=",
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}
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},
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}
}
}
},
{
"identified_line": {
"line": "* Patients who are not suitable to participate in this trial for any reason judged by the investigator.",
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{
"exact_snippets": "not suitable to participate in this trial for any reason judged by the investigator",
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"requirement_type": "judgment",
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},
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{
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]
}
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],
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"requirement_type": "method",
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"cytological"
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{
"exact_snippets": "unresectable metastatic colorectal adenocarcinoma",
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{
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"failed",
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},
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{
"and_criteria": [
{
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]
}
},
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"line": "* Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present. Serum albumin ≥3 g/dL.",
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"operator": "<=",
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}
},
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":{"
]
}
},
{
"exact_snippets": "Serum albumin ≥3 g/dL",
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"operator": ">=",
"value": 3,
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}
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]
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{
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"operator": "<=",
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"operator": "<=",
"value": 2.5,
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}
}
]
}
},
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"identified_line": {
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{
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"operator": "<=",
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},
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"operator": ">=",
"value": 60,
"unit": "mL/min"
}
}
},
{
"exact_snippets": "Proteinuria < 2+",
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"operator": "<",
"value": 2,
"unit": "+"
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}
},
{
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"operator": "<=",
"value": 1,
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}
]
},
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"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate renal function as evidenced by serum creatinine (Cr) \u00151.5 \u001d ULN",
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"operator": "<=",
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"unit": "\u001d ULN"
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}
},
{
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{
"and_criteria": [
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},
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]
},
{
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{
"exact_snippets": "Adequate renal function as evidenced by serum creatinine (Cr) \u00151.5 \u001d ULN",
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"operator": "<=",
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}
},
{
"exact_snippets": "those with proteinuria \u001e2+ at baseline had to demonstrate \u001d1 g protein per 24 hours",
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"operator": "<=",
"value": 1,
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]
},
{
"and_criteria": [
{
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"operator": ">=",
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}
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{
"exact_snippets": "those with proteinuria \u001e2+ at baseline had to demonstrate \u001d1 g protein per 24 hours",
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}
}
],
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{
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"operator": "<=",
"value": 5,
"unit": "years"
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}
},
{
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"requirement_type": "presence",
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{
"exact_snippets": "basal cell carcinoma",
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"requirement_type": "presence",
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]
},
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}
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"exact_snippets": "Previous treatment with irinotecan",
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},
{
"exact_snippets": "Previous treatment with ... liposomal irinotecan",
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]
},
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}
},
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{
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},
{
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"requirement_type": "mutation status",
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}
},
{
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"requirement_type": "usage",
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},
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},
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{
"exact_snippets": "high microsatellite instability (MSI-H)",
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]
},
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}
},
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},
{
"exact_snippets": "Massive pleural effusion",
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}
},
{
"exact_snippets": "ascites requiring intervention",
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]
},
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},
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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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}
},
{
"exact_snippets": "require systemic treatment",
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]
},
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],
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}