{
"info": {
"nct_id": "NCT06844357",
"official_title": "A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients with Intermediate-Stage Hepatocellular Carcinoma (HCC)",
"inclusion_criteria": "* Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.\n* No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.\n* Patients must be eligible for TAE or TACE treatment.\n* ECOG ≤ 1.\n* Child-Pugh score ≤ 7.\n* Adequate bone marrow, liver, and kidney function is required.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* History of liver transplantation.\n* Previous radioemblization or radiotherapy for liver tumors.\n* severe cardiovascular or renal diseases, active systemic infections.\n* Clinically significant hypoxia (oxygen saturation < 92% without oxygen supplementation)",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.",
"criterions": [
{
"exact_snippets": "diagnosed with primary hepatocellular carcinoma",
"criterion": "primary hepatocellular carcinoma",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"exact_snippets": "according to AASLD criteria",
"criterion": "AASLD criteria",
"requirements": [
{
"requirement_type": "compliance",
"expected_value": true
}
]
}
]
},
{
"line": "* No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.",
"criterions": [
{
"exact_snippets": "No evidence of extrahepatic metastasis",
"criterion": "extrahepatic metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No evidence of ... regional lymph node involvement",
"criterion": "regional lymph node involvement",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No evidence of ... vascular tumor thrombus",
"criterion": "vascular tumor thrombus",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients must be eligible for TAE or TACE treatment.",
"criterions": [
{
"exact_snippets": "eligible for TAE or TACE treatment",
"criterion": "TAE or TACE treatment eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "* Child-Pugh score ≤ 7.",
"criterions": [
{
"exact_snippets": "Child-Pugh score ≤ 7",
"criterion": "Child-Pugh score",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Adequate bone marrow, liver, and kidney function is required.",
"criterions": [
{
"exact_snippets": "Adequate bone marrow ... function is required.",
"criterion": "bone marrow function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... liver ... function is required.",
"criterion": "liver function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Adequate ... kidney function is required.",
"criterion": "kidney function",
"requirements": [
{
"requirement_type": "adequacy",
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* History of liver transplantation.",
"criterions": [
{
"exact_snippets": "History of liver transplantation",
"criterion": "liver transplantation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Previous radioemblization or radiotherapy for liver tumors.",
"criterions": [
{
"exact_snippets": "Previous radioemblization ... for liver tumors.",
"criterion": "radioemblization for liver tumors",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "Previous ... radiotherapy for liver tumors.",
"criterion": "radiotherapy for liver tumors",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* severe cardiovascular or renal diseases, active systemic infections.",
"criterions": [
{
"exact_snippets": "severe cardiovascular ... diseases",
"criterion": "cardiovascular diseases",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "severe ... renal diseases",
"criterion": "renal diseases",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "active systemic infections",
"criterion": "systemic infections",
"requirements": [
{
"requirement_type": "activity",
"expected_value": "active"
}
]
}
]
},
{
"line": "* Clinically significant hypoxia (oxygen saturation < 92% without oxygen supplementation)",
"criterions": [
{
"exact_snippets": "Clinically significant hypoxia (oxygen saturation < 92% without oxygen supplementation)",
"criterion": "oxygen saturation",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "clinically significant"
},
{
"requirement_type": "level",
"expected_value": {
"operator": "<",
"value": 92,
"unit": "%"
}
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}