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Completed

NCT Number: NCT04780802

Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The balloon catheter is placed at the various arterial feeders of the tumor

Procedure

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.

Primary outcomes

  1. The change in hemodynamics of arterial blood supply to HCC tumors

    Time frame: immediately after completion of procedure

    The change in number of feeding arteries

  2. The change in the perfusion pattern of HCC tumors

    Time frame: immediately after completion of procedure

    The change in perfusion pressure.

Secondary outcomes

  1. Tumor response

    Time frame: 3 months

    Tumor response by CT such as complete response according to European Association for the Study of the Liver (EASL) necrosis guidelines.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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