A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

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. Unresectable advanced HCCs 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 by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain. The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Official Title
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A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: transarterial radioembolization (TARE)
* Procedure: transarterial chemoembolization (TACE)


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 unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment) Patients with single large HCC or multinodular HCC Single & 5cm < size < 15cm 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm Infiltrative type & unilobular involvement on liver MRI Segmental or lobar portal vein invasion can be included. Age : 20 years to 80 years ECOG Performance Status of 0 to 2 Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7) Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: WBC count ≧ 1,000/mm3 Absolute neutrophil count > 500/mm3 Hb ≧ 7.0 g/dL Platelet count > 100,000 /mm3 Bilirubin ≦ 3 mg/dL Adequate clotting function: INR ≦ 2.3 or ≦ 6sec Exclusion Criteria: Child-Pugh score ≧ 8 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 who have received Capecitabine within 8 weeks Patients with extrahepatic metastasis Main portal vein invasion Patients with lymph node metastasis Bilobar involvement Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count) Pregnancy

Ages Eligible for Study
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Minimum Age: 20 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 TARE group<br>transarterial radioembolization group | Procedure: transarterial radioembolization (TARE)<br>* transarterial radioembolization<br>|
| Experimental: The TACE group<br>Transarterial chemoembolization group | Procedure: transarterial chemoembolization (TACE)<br>* transarterial chemoembolization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | From date of randomization until the date of death | every 12 weeks, up to the time of death, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival in the Liver | From date of randomization until the date of first documented intrahepatic tumor progression or death | every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months | 
| Progression-Free Survival Overall | From date of randomization until the date of first documented progression or death | every 12 weeks, up to the time of death or first documented progression, up to 12 months | 
| Overall tumor response assessment | (CR, PR, SD, PD)by modified RECIST criteria | every 12 weeks, up to the time of death or 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transarterial chemoembolization, transarterial radioembolization, advanced hepatocellular carcinoma