Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Detailed Description
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Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy. However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients. The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Official Title
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A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Doxorubicin
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible Age : 18 years to 80 years ECOG Performance Status of 0 to 2 Child-Pugh class A (Child-Pugh score 5-6) Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: WBC count > 2,000/mm3 Absolute neutrophil count > 1,000/mm3 Hb ≧ 8.0 g/dL Platelet count ≧ 50,000 /mm3 Bilirubin ≦ 3 mg/dL Adequate clotting function: INR < 2.3 or < 6sec Exclusion Criteria: Child-Pugh score ≧ 7 ECOG Performance Status ≧ 3 Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL History of organ allograft Patients with uncontrolled co-morbidity which needs treatment Patients who have received prior systemic chemotherapy Patients with extrahepatic metastasis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: The TACE/TACI combination group<br>Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination | Drug: Doxorubicin<br>* Transarterial chemoembolization (TACE) with adriamycin<br>* Other names: Adriamycin;Drug: Cisplatin<br>* transarterial chemoinfusion with cisplatin 50-100 mg<br>|
| Active Comparator: The TACE-only group<br>Transarterial chemoembolization with doxorubicin | Drug: Doxorubicin<br>* Transarterial chemoembolization (TACE) with adriamycin<br>* Other names: Adriamycin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | every 12 weeks, up to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-progression |  | every 12 weeks, up to 48 weeks | 
| Progression-free survival |  | every 12 weeks, up to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, portal vein invasion, transarterial chemoembolization, transarterial chemoinfusion