{
"info": {
"nct_id": "NCT01695772",
"official_title": "A Multi-Center, Single-Arm, Pilot Study of 5-FU Based Doublet Chemotherapy Plus Bevacizumab as Neoadjuvant Therapy for Patients With Previously Untreated Unresectable Liver-Only Metastases From Colorectal Cancer",
"inclusion_criteria": "* Adult Chinese participants, 18-75 years of age\n* Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed\n* Previously untreated unresectable liver-only metastases\n* Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).\n* No previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, Transarterial chemoembolisation therapy (TACE) and target therapy\n* Adequate hematological, renal and hepatic function\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Life expectancy greater than (>) 3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* The relapse has occurred within 6 months of completion of the adjuvant treatment\n* Expected impossible to achieve complete resection (R0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy\n* Participant cannot tolerate the surgery\n* Other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix\n* Any extrahepatic metastases and/or recurrence of the primary tumor\n* Any residual toxicity from previous chemotherapy (except alopecia) of National Cancer Institute Common Toxicity Criteria (NCI CTC) v.4.0 grade 2\n* Hypertension crisis or encephalopathy\n* Pregnant or lactating women\n* Clinically significant cardiovascular disease\n* Evidence of bleeding diathesis or coagulopathy\n* Current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin\n* History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Adult Chinese participants, 18-75 years of age",
"criterions": [
{
"exact_snippets": "Adult Chinese participants",
"criterion": "ethnicity",
"requirement": {
"requirement_type": "specific ethnicity",
"expected_value": "Chinese"
}
},
{
"exact_snippets": "18-75 years of age",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adult Chinese participants",
"criterion": "ethnicity",
"requirement": {
"requirement_type": "specific ethnicity",
"expected_value": "Chinese"
}
},
{
"exact_snippets": "18-75 years of age",
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{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
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},
{
"identified_line": {
"line": "* Previously untreated unresectable liver-only metastases",
"criterions": [
{
"exact_snippets": "Previously untreated",
"criterion": "treatment status",
"requirement": {
"requirement_type": "treatment history",
"expected_value": "untreated"
}
},
{
"exact_snippets": "unresectable",
"criterion": "resectability",
"requirement": {
"requirement_type": "surgical resectability",
"expected_value": false
}
},
{
"exact_snippets": "liver-only metastases",
"criterion": "metastasis location",
"requirement": {
"requirement_type": "location",
"expected_value": "liver-only"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Previously untreated",
"criterion": "treatment status",
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"expected_value": "untreated"
}
},
{
"exact_snippets": "unresectable",
"criterion": "resectability",
"requirement": {
"requirement_type": "surgical resectability",
"expected_value": false
}
},
{
"exact_snippets": "liver-only metastases",
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"requirement": {
"requirement_type": "location",
"expected_value": "liver-only"
}
}
]
}
},
{
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"line": "* Liver lesions determined to be unresectable by multidisciplinary team (MDT, consisting of experienced hepatic surgeons, medical oncologist and radiologist).",
"criterions": [
{
"exact_snippets": "Liver lesions determined to be unresectable",
"criterion": "liver lesions",
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"requirement_type": "resectability",
"expected_value": false
}
}
]
},
"logical_structure": {
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"exact_snippets": "Liver lesions determined to be unresectable",
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}
}
]
}
},
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"identified_line": {
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"criterions": [
{
"exact_snippets": "No previous treatment against liver metastases",
"criterion": "previous treatment against liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... chemotherapy",
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"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... surgery",
"criterion": "previous surgery treatment against liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... radiotherapy",
"criterion": "previous radiotherapy treatment against liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... Transarterial chemoembolisation therapy (TACE)",
"criterion": "previous Transarterial chemoembolisation therapy (TACE) against liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... target therapy",
"criterion": "previous target therapy against liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No previous treatment against liver metastases",
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"expected_value": false
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"or_criteria": [
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"exact_snippets": "No previous treatment ... chemotherapy",
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}
},
{
"exact_snippets": "No previous treatment ... radiotherapy",
"criterion": "previous radiotherapy treatment against liver metastases",
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"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... Transarterial chemoembolisation therapy (TACE)",
"criterion": "previous Transarterial chemoembolisation therapy (TACE) against liver metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No previous treatment ... target therapy",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
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]
}
},
{
"identified_line": {
"line": "* Adequate hematological, renal and hepatic function",
"criterions": [
{
"exact_snippets": "Adequate hematological ... function",
"criterion": "hematological function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hepatic function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hematological ... function",
"criterion": "hematological function",
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"expected_value": true
}
},
{
"exact_snippets": "Adequate ... renal ... function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate ... hepatic function",
"criterion": "hepatic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Life expectancy greater than (>) 3 months",
"criterions": [
{
"exact_snippets": "Life expectancy greater than (>) 3 months",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
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}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Life expectancy greater than (>) 3 months",
"criterion": "life expectancy",
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"operator": ">",
"value": 3,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
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"requirement_type": "status",
"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",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
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"exact_snippets": "minimum age of 18 Years",
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}
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},
{
"identified_line": {
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{
"exact_snippets": "maximum age of 75 Years",
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"unit": "Years"
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}
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}
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],
"exclusion_lines": [
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{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
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"unit": "months"
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{
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}
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"unit": "%"
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}
}
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}
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{
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"unit": "%"
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}
}
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}
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}
}
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}
}
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"unit": "years"
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}
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}
},
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}
},
{
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}
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"and_criteria": [
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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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{
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"criterion": "residual toxicity from previous chemotherapy",
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}
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}
},
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{
"exact_snippets": "Hypertension crisis",
"criterion": "hypertension crisis",
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}
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{
"exact_snippets": "Pregnant",
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"expected_value": false
}
},
{
"exact_snippets": "lactating women",
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}
},
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"expected_value": false
}
}
]
}
},
{
"identified_line": {
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{
"exact_snippets": "Clinically significant cardiovascular disease",
"criterion": "cardiovascular disease",
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}
}
]
},
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}
}
}
},
{
"identified_line": {
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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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}
},
{
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"criterion": "warfarin use",
"requirement": {
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}
},
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of ... warfarin",
"criterion": "warfarin use",
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"expected_value": "full dose"
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of aspirin",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "time frame",
"expected_value": "current or recent (within 10 days of study drug initiation)"
}
},
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of aspirin",
"criterion": "aspirin use",
"requirement": {
"requirement_type": "dosage",
"expected_value": "full dose"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of ... clopidrogel",
"criterion": "clopidrogel use",
"requirement": {
"requirement_type": "time frame",
"expected_value": "current or recent (within 10 days of study drug initiation)"
}
},
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of ... clopidrogel",
"criterion": "clopidrogel use",
"requirement": {
"requirement_type": "dosage",
"expected_value": "full dose"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of ... warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "time frame",
"expected_value": "current or recent (within 10 days of study drug initiation)"
}
},
{
"exact_snippets": "Current or recent (within 10 days of study drug initiation) use of full dose of ... warfarin",
"criterion": "warfarin use",
"requirement": {
"requirement_type": "dosage",
"expected_value": "full dose"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* History or evidence of Central Nervous System (CNS) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)",
"criterions": [
{
"exact_snippets": "History or evidence of Central Nervous System (CNS) disease",
"criterion": "Central Nervous System (CNS) disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "primary brain tumor",
"criterion": "primary brain tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "seizures not controlled with standard medical therapy",
"criterion": "seizures",
"requirement": {
"requirement_type": "control",
"expected_value": "not controlled with standard medical therapy"
}
},
{
"exact_snippets": "any brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of stroke",
"criterion": "stroke",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "History or evidence of Central Nervous System (CNS) disease",
"criterion": "Central Nervous System (CNS) disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "primary brain tumor",
"criterion": "primary brain tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "seizures not controlled with standard medical therapy",
"criterion": "seizures",
"requirement": {
"requirement_type": "control",
"expected_value": "not controlled with standard medical therapy"
}
},
{
"exact_snippets": "any brain metastases",
"criterion": "brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of stroke",
"criterion": "stroke",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed",
"criterions": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"exact_snippets": "in colon or rectum",
"criterion": "location of adenocarcinoma",
"requirement": {
"requirement_type": "location",
"expected_value": [
"colon",
"rectum"
]
}
},
{
"exact_snippets": "primary lesion surgically removed",
"criterion": "primary lesion",
"requirement": {
"requirement_type": "surgical removal",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Histologically confirmed adenocarcinoma",
"criterion": "adenocarcinoma",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
},
{
"or_criteria": [
{
"exact_snippets": "in colon or rectum",
"criterion": "location of adenocarcinoma",
"requirement": {
"requirement_type": "location",
"expected_value": "colon"
}
},
{
"exact_snippets": "in colon or rectum",
"criterion": "location of adenocarcinoma",
"requirement": {
"requirement_type": "location",
"expected_value": "rectum"
}
}
]
}
]
},
{
"exact_snippets": "primary lesion surgically removed",
"criterion": "primary lesion",
"requirement": {
"requirement_type": "surgical removal",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "0"
}
},
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": "1"
}
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}