Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma

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

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

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: The balloon catheter is placed at the various arterial feeders of the tumor

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Simon Yu, Professor, DIIR, CUHK, Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: VIR-20-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No