Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.

Detailed Description
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Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions of hepatocellular carcinoma (HCC) not eligible for surgical resection, transplantation, or local ablative therapy. The use of balloon assisted TACE has been proposed recently and it could be one of the possible ways to improve the effectiveness of drug delivery to the target tumor and therefore leading to improved treatment outcome.

Official Title
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Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma: a Study on the Proof of Treatment Concept and Exploration of Selection Criteria for Clinical Application

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: The balloon catheter is placed at the various arterial feeders of the tumor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of age above 18 years Patients who are indicated for transarterial treatment for HCC Child-Pugh A or B cirrhosis Eastern Cooperative Oncology Group performance score 0 or 1 BCLC A or B 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 <= 7cm in largest dimension Serum creatinine < 130 umol/L or Creatinine clearance > 55 ml/min. Exclusion Criteria: Concurrent ischemic heart disease or heart failure History of asthma, chronic obstructive airway disease or respiratory decompensation. 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 < 26 g/L INR > 1.3 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: 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ballloon catheter<br>Balloon-assisted transarterial therapy will be performed in the first treatment session only | Procedure: The balloon catheter is placed at the various arterial feeders of the tumor<br>* use of a balloon catheter for providing balloon occlusion, in addition to the standard microcatheter for drug delivery, both catheters are to be placed in parallel through a single guide catheter. Only one arterial puncture wound is involved. The inflated balloon provides temporary occlusion of all arterial tumor feeders except for the one which is selectively catheterized with a microcatheter for delivery of the therapeutic agent. The therapeutic agent consists of Lipiodol mixed with a chemotherapeutic drug, it is delivered through the microcatheter under fluoroscopic control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in hemodynamics of arterial blood supply to HCC tumors | The change in number of feeding arteries | immediately after completion of procedure | 
| The change in the perfusion pattern of HCC tumors | The change in perfusion pressure. | immediately after completion of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Tumor response by CT such as complete response according to European Association for the Study of the Liver (EASL) necrosis guidelines. | 3 months |