{
"info": {
"nct_id": "NCT06479473",
"official_title": "Chemoimmunotherapy Followed by All-residual-lesions Radiotherapy for Extensive-stage Small-cell Lung Cancer: A Phase I/II Trial",
"inclusion_criteria": "* 18-70 years old;\n* ECOG 0-1;\n* Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;\n* Small-cell lung cancer;\n* Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;\n* Signature of inform consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "Younger than 18 years old or older than 70 years old;\n\n* ECOG>1;\n* Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;\n* Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;\n* Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;\n* No signature of inform consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* 18-70 years old;",
"criterions": [
{
"exact_snippets": "18-70 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 70,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* ECOG 0-1;",
"criterions": [
{
"exact_snippets": "ECOG 0-1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 1,
"unit": "N/A"
}
]
}
}
]
}
]
},
{
"line": "* Adequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;",
"criterions": [
{
"exact_snippets": "Adequate organ function to tolerate chemotherapy",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
},
{
"requirement_type": "tolerance",
"expected_value": "chemotherapy"
}
]
},
{
"exact_snippets": "Adequate organ function to tolerate ... immunotherapy",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
},
{
"requirement_type": "tolerance",
"expected_value": "immunotherapy"
}
]
},
{
"exact_snippets": "Adequate organ function to tolerate ... radiotherapy",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
},
{
"requirement_type": "tolerance",
"expected_value": "radiotherapy"
}
]
}
]
},
{
"line": "* Small-cell lung cancer;",
"criterions": [
{
"exact_snippets": "Small-cell lung cancer",
"criterion": "small-cell lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;",
"criterions": [
{
"exact_snippets": "Extensive stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT",
"criterion": "extensive stage",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": [
"cranial MRI",
"chest CT",
"abdominal ultrasonograph",
"bone scan",
"PET-CT"
]
}
]
}
]
},
{
"line": "* Signature of inform consent.",
"criterions": [
{
"exact_snippets": "Signature of inform consent.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signature",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "Younger than 18 years old or older than 70 years old;",
"criterions": [
{
"exact_snippets": "Younger than 18 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 18,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "older than 70 years old",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 70,
"unit": "years"
}
]
}
}
]
}
]
},
{
"line": "* Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy;",
"criterions": [
{
"exact_snippets": "Inadequate organ function to tolerate chemotherapy, immunotherapy and radiotherapy",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": false
}
]
}
]
},
{
"line": "* Non-small cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;",
"criterions": [
{
"exact_snippets": "Non-small cell lung cancer",
"criterion": "non-small cell lung cancer",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma",
"criterion": "neuroendocrine carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;",
"criterions": [
{
"exact_snippets": "Limited stage confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT",
"criterion": "limited stage",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": [
"cranial MRI",
"chest CT",
"abdominal ultrasonograph",
"bone scan",
"PET-CT"
]
}
]
}
]
},
{
"line": "* No signature of inform consent.",
"criterions": [
{
"exact_snippets": "No signature of inform consent.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signature",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* ECOG>1;",
"criterions": [
{
"exact_snippets": "ECOG>1",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "performance status",
"expected_value": {
"operator": ">",
"value": 1,
"unit": "N/A"
}
}
]
}
]
}
],
"failed_miscellaneous": []
}