HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China

Study Overview
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Brief Summary
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The purpose of this multicenter registry is to gather the safety, efficacy and survival data in advanced HCC patients treated with HepaSphere in China in order to evaluate the application of HepaSphere deTACE in treating advanced HCC patients

Official Title
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Superselective Drug-Eluting Chemoembolization With HepaSphere in Unresectable Advanced HCC Patients: Safety & Efficacy Registry in China (SUPER-China)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: HepaSphere with 50-75mg Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Patient has signed informed consent Patient must have a diagnosis of hepatocellular cancer by at least one of the following method: Histological confirmation Classic imaging characteristics of HCC: Early enhancement (Arterial hypervascularity) and Venous or Delayed phase washout in multidetector contrast enhanced computed tomography (CT) scan / dynamic contrast-enhanced magnetic resonance imaging (MRI) imaging. Either CT/ MRI shows at least one solid liver lesion ≥ 2 cm with the above described imaging characteristics of HCC. In case of liver lesion between 1 and 2 cm, both CT and MRI imaging have to be performed in order to confirm the imaging characteristics of HCC. At time of study entry. Patients not suitable for ablation due to lesion location may be enrolled Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled Patient MUST be with BCLC stage C and meet the following criteria: Stage Child-Pugh A or B AND Performance status ECOG ≤ 2 WITH Vascular Invasion or WITHOUT Vascular invasion Patient has a life expectancy of at least 6 months Exclusion Criteria: Current or previous treatment with chemo- or radiation therapy or sorafenib Previous treatment of transarterial chemoembolization (TACE) Patients with current or history of any other cancer except non-melanomatous skin cancer Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive Performance status ECOG > 2 Child-Pugh Class C Occlusive tumor thrombus to the main portal trunk Active gastrointestinal bleeding Evidence of uncorrectable bleeding diathesis Extra-Hepatic spread of the HCC >50% tumor involvement of the liver Infiltrative HCC Encephalopathy not adequately controlled medically Presence of ascites not controlled medically Any contraindication for MRI/ CT (eg. metallic implants) Allergy to contrast media that cannot be managed with prophylaxis Any contraindication to arteriography Any contraindication for doxorubicin administration

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device: HepaSphere Microspheres<br>HepaSphere Microsphere | Device: HepaSphere with 50-75mg Doxorubicin<br>* HepaSphere with 50-75mg Doxorubicin<br>* Other names: Superaborbent Polymer Microsphere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 2- years | 
| Progress-free-survival (PFS) |  | 2-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 2-years | 
| Objective Response Rates |  | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HepaSphere