Status:
UNKNOWN
Lipiodol-TACE With Idarubicin for Hepatocellular Carcinoma
Lead Sponsor:
Zhongda Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this real-world study is to evaluate the safety and efficacy of lipiodol-TACE with idarubicin for hepatocellular carcinoma.
Detailed Description
Idarubicin is a DNA topoisomerase II inhibitor that promotes DNA strand breakage, trapping cells in the G2 phase of the cell cycle and inducing DNA cleavage and cell apoptosis. At the same time, it ca...
Eligibility Criteria
Inclusion
- 1).18-75 years old; no gender limit; 2).Confirmed diagnosis of HCC according to histopathology or CNLC guidelines (2019 Edition); 3）Life expectancy≥3 months; 4).Child-Pugh class A or B; 5).ECOG PS of 0 or 1;6).One of the following cases: CNLC stage IIb and IIIa; CNLC stage Ib and IIa patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); The main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement; 7). At least one measurable lesion (the length diameter≥10mm); 8).Laboratory indices: WBC≥3.0×109/L; PLT≥50×109/L; Hb≥70g/L; Cr≤1.5×UNL(upper limit of normal); BIL≤2.0×UNL, ALT≤5.0×UNL, AST≤5.0×UNL.
Exclusion
- 1).The coagulation function is severely decreased and cannot be recovered; 2).The main portal vein is completely embolized by cancer embolism, with few collateral vessels; 3).With active hepatitis or severe infection that cannot be treated at the same time; 4). With cachexia or multiple organ failure; 5). With uncontrollable neurological and mental disorders, or poor compliance; 6.) Primary brain tumors or central nervous system metastasis has not been controlled, with obvious intracranial hypertension or neuropsychiatric symptoms; 7). Pregnant or breast feeding women; 8). Received drug treatments in other clinical trial in the past 4 weeks; 9). Other situations where the investigators judge that the patient should not participate in.
Key Trial Info
Start Date :
May 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05280444
Start Date
May 28 2022
End Date
July 30 2023
Last Update
December 29 2022
Active Locations (1)
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1
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009