{
"info": {
"nct_id": "NCT04431791",
"official_title": "A Single-center,Observational,Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies",
"inclusion_criteria": "1. signed and dated informed consent.\n2. Diagnosis of histologically confirmed colorectal cancer, stage IV.\n3. after second-line therapy.\n4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.",
"exclusion_criteria": "1. received regorafenib or fruquintinib before third-line therapy.\n2. the clinicopathological characteristics and previous therapy were unknown.\n3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. signed and dated informed consent.",
"criterions": [
{
"exact_snippets": "signed and dated informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"expected_value": true
},
{
"requirement_type": "dated",
"expected_value": true
}
]
}
]
},
{
"line": "2. Diagnosis of histologically confirmed colorectal cancer, stage IV.",
"criterions": [
{
"exact_snippets": "Diagnosis of histologically confirmed colorectal cancer",
"criterion": "colorectal cancer",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
}
]
},
{
"exact_snippets": "stage IV",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "IV"
}
]
}
]
},
{
"line": "3. after second-line therapy.",
"criterions": [
{
"exact_snippets": "after second-line therapy",
"criterion": "prior therapy",
"requirements": [
{
"requirement_type": "stage",
"expected_value": "after second-line"
}
]
}
]
},
{
"line": "4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.",
"criterions": [
{
"exact_snippets": "gastrointestinal physician prescribed",
"criterion": "gastrointestinal physician prescription",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "receive regorafenib or fruquintinib",
"criterion": "medication",
"requirements": [
{
"requirement_type": "options",
"expected_value": [
"regorafenib",
"fruquintinib"
]
}
]
},
{
"exact_snippets": "according the patients' condition",
"criterion": "patients' condition",
"requirements": [
{
"requirement_type": "consideration",
"expected_value": "condition-based"
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. received regorafenib or fruquintinib before third-line therapy.",
"criterions": [
{
"exact_snippets": "received regorafenib",
"criterion": "regorafenib treatment",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
},
{
"exact_snippets": "received ... fruquintinib",
"criterion": "fruquintinib treatment",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
},
{
"line": "2. the clinicopathological characteristics and previous therapy were unknown.",
"criterions": [
{
"exact_snippets": "clinicopathological characteristics",
"criterion": "clinicopathological characteristics",
"requirements": [
{
"requirement_type": "knowledge",
"expected_value": false
}
]
},
{
"exact_snippets": "previous therapy",
"criterion": "previous therapy",
"requirements": [
{
"requirement_type": "knowledge",
"expected_value": false
}
]
}
]
},
{
"line": "3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.",
"criterions": [
{
"exact_snippets": "regorafenib or fruquintinib treatment is less than one cycle",
"criterion": "regorafenib or fruquintinib treatment",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 1,
"unit": "cycle"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}