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CompletedNCT04780802Updated Oct 21, 2022

Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

An interventional study of The balloon catheter is placed at the various arterial feeders of the tumor in Hepatocellular Carcinoma, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Hepatocellular Carcinoma
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In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's enrollment of 10 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients of age above 18 years
  2. Patients who are indicated for transarterial treatment for HCC
  3. Child-Pugh A or B cirrhosis
  4. Eastern Cooperative Oncology Group performance score 0 or 1
  5. BCLC A or B
  6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
  7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
  8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
  9. No invasion of portal vein or hepatic vein
  10. 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)
  11. Total tumor mass \< 50% liver volume
  12. Size of any individual tumor \<= 7cm in largest dimension
  13. Serum creatinine \< 130 umol/L or Creatinine clearance > 55 ml/min.

Exclusion criteria

Exclusion Criteria:

  1. Concurrent ischemic heart disease or heart failure
  2. History of asthma, chronic obstructive airway disease or respiratory decompensation.
  3. History of acute tumor rupture presenting with hemo-peritoneum
  4. Biliary obstruction not amenable to percutaneous or endoscopic drainage
  5. Child-Pugh C cirrhosis
  6. History of hepatic encephalopathy
  7. Intractable ascites not controllable by medical therapy
  8. History of variceal bleeding within last 3 months
  9. Serum total bilirubin level > 50 umol/L
  10. Serum albumin level \< 26 g/L
  11. INR > 1.3
  12. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
  13. Arterio-portal venous shunt affecting >1 hepatic segment on CT
  14. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Ballloon catheter

    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

Interventions

  • ProcedureThe balloon catheter is placed at the various arterial feeders of the tumor

    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.

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What researchers measure

Primary outcomes

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

    The change in number of feeding arteries

    Time frame: immediately after completion of procedure

  2. The change in the perfusion pattern of HCC tumors

    The change in perfusion pressure.

    Time frame: immediately after completion of procedure

Secondary outcomes

  1. Tumor response

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

    Time frame: 3 months

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Study locations

1 site
  • Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
    Hong Kong, Hong Kong
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04780802
Responsible party
Simon Yu (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Mar 4, 2021
Start date
May 1, 2022
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Oct 21, 2022

Study contacts

Simon Yu, Professor
principal investigator · DIIR, CUHK, Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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