Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma
NCT ID: NCT00493402
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
365 participants
INTERVENTIONAL
2007-07-31
2010-12-31
Brief Summary
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Detailed Description
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Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.
Regimen 1: lipiodol combined chemotherapy with embolization
Regimen 2: lipiodol combined chemotherapy without embolization
Regimen 3: lipiodol single agent chemotherapy with embolization
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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combined chemotherapy with embolization
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.
Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
combined chemotherapy without embolization
chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.
Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
single agent chemotherapy with embolization
chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Interventions
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Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.
Transarterial chemoembolization (TACE)
drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.
Transarterial chemoembolization (TACE)
Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Eligibility Criteria
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Inclusion Criteria
* Histological confirmed HCC
* with no previous treatment
* With unresectable tumor
* With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
* No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
* No significant renal impairment (creatinine clearance \< 30 mL/minute)
* The following laboratory parameters:
* Platelet count ≥ 60,000/µL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 1.5 mg/dL
* ASL and AST ≤ 5 x upper limit of normal
* Serum albumin ≥ 35 g/L
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or a Pt/PTT within normal limits
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria
* Main portal vein obstruction without cavernous transformation
* Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
* Obstructive jaundice
* Severe underlying cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or breast-feeding patients.
* History of organ allograft
* Active clinically serious infections
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, China
OTHER_GOV
Guangdong Provincial People's Hospital
OTHER
The 458 Hospital of Chinese PLA
OTHER
Kaiping Central Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Shi Ming
Dr.
Principal Investigators
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Jin-Qing Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Center, Sun Yat-set University
Locations
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Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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Other Identifiers
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hcc-001
Identifier Type: -
Identifier Source: org_study_id