Hepatocellular Carcinoma
Conditions
Brief summary
The purpose of this study is to determine that systemic chemotherapy is superior to transcatheter arterial chemoembolization in prolonging progression-free survival（PFS） in patients with Advanced Hepatocellular Carcinoma.
Interventions
DRUGPirarubicin
1. Pirarubicin 30mg/m2 intravenously 2. Pirarubicin17mg/m2 are infused through the right and left hepatic arteries
DRUGOxaliplatin
1. Oxaliplatin 100 mg/m2 intravenously 2. Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries
DRUGLipiodol
Lipiodol 5-10ml infused through the right and left hepatic arteries
DEVICEGelfoam
Hepatic artery embolization with Gelfoam.
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients were age 18 to 75 years; * The patients had histologically, cytologically,or clinically diagnosed unresectable HCC;and were ineligible for local invasive treatment. Clinically diagnosed patients had to have: (1) evidence of HBV or HCV with hepatic cirrhosis; (2) a-fetoprotein levels 400g/L; and (3) morphologic evidence of hypervascular liver tumor. Patients had to have at least one measurable lesion according to RECIST (version 1.0; ≥2 cm on computed tomography \[CT\]; 1 cm on spiral CT or magnetic resonance imaging). Lesions that had undergone previous interventional or local therapy were not considered measurable lesions. * ECOG score≤2; * life expectancy 3 months; * Barcelona Clinic liver cancer (BCLC) stage B or C disease; * Child-Pugh stage A or B disease; * Adequate organ and marrow function, with neutrophil count≥1.5X10e9/L, platelet count≥75×10e9/L, AST or ALT﹤2.5×upper limit of normal (ULN), total bilirubin \<1.5×ULN, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction\_lower limit of normal for the institution. Patients with AST and ALT\<5 ×ULN could be recruited if total bilirubin was in the normal range. * Patients had to provide signed informed consent to participate.
Exclusion criteria
* documented allergy to lipoidal or other study drugs; any previous treatment before random assignment; * Previous liver transplantation; * concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion); * CNS metastasis; * Other serious illness or medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | 3 months |
| Overall survival | 6 months and 12 months |
| Time-to-Progression | 3 months |
| Time-to-Progression within liver | 3 months |
| Time-to-Progression outside the liver | 3 months |
Outcome results
None listed