Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

NCT04780802 | Completed DMC

• 1 other identifier: VIR-20-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Tumor response

  3 months

Study Arms (1)

Ballloon catheter

OTHER

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

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.

Ballloon catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Simon Yu, Professor

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: March 4, 2021
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)