Systemic Chemotherapy Versus Transcatheter Arterial Chemoembolization(TACE) for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Systemic Chemotherapy VersusTranscatheter Arterial Chemoembolization As Palliative Chemotherapy in Patients With Advanced Hepatocellular Carcinoma(HCC)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Pirarubicin
* Drug: Oxaliplatin
* Drug: Lipiodol
* Device: Gelfoam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: systemic chemotherapy<br>Pirarubicin 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity. | Drug: Pirarubicin<br>* Pirarubicin 30mg/m2 intravenously Pirarubicin17mg/m2 are infused through the right and left hepatic arteries<br>Drug: Oxaliplatin<br>* Oxaliplatin 100 mg/m2 intravenously Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries<br>* Other names: Eloxatin;|
| Active Comparator: Transcatheter Arterial Chemoembolization<br>Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity. | Drug: Pirarubicin<br>* Pirarubicin 30mg/m2 intravenously Pirarubicin17mg/m2 are infused through the right and left hepatic arteries<br>Drug: Oxaliplatin<br>* Oxaliplatin 100 mg/m2 intravenously Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries<br>* Other names: Eloxatin;Drug: Lipiodol<br>* Lipiodol 5-10ml infused through the right and left hepatic arteries<br>Device: Gelfoam<br>* Hepatic artery embolization with Gelfoam.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free-Survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |