Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The objective of this study is to study the safety and tumor response of ACE for large HCC.

Detailed Description
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Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size >10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size >10cm.

Official Title
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Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Procedure: Ablative chemoembolization (ACE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signage of a written informed consent Age above 18 years HCC unsuitable for resection Child-Pugh A or B cirrhosis Eastern Cooperative Oncology Group performance score 0 or 1 No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy), HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen. No invasion of portal vein or hepatic vein Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions) Total tumor mass < 50% liver volume Size of any individual tumor >10cm in largest dimension Exclusion Criteria: History of acute tumor rupture presenting with hemo-peritoneum Biliary obstruction not amenable to percutaneous or endoscopic drainage Child-Pugh C cirrhosis History of hepatic encephalopathy Intractable ascites not controllable by medical therapy History of variceal bleeding within last 3 months Serum total bilirubin level > 50 umol/L Serum albumin level < 25g/L INR > 1.7 Serum creatinine level > 150 mmol/L. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules) Arterio-portal venous shunt affecting >1 hepatic segment on CT Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT

Ages Eligible for Study
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Minimum Age: 19 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
Intervention Model: Single Group Assignment
Interventional Model Description: Use of ACE for HCC of size > 10cm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ACE for HCC of size >10cm<br>Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin | Procedure: Ablative chemoembolization (ACE)<br>* Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression | 3 to 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Tumor response at 3 month and 6 month from the date of first treatment as evaluated by triphasic contrast enhanced CT according to the EASL criteria | 3 to 6 months after treatment |