Back to resultsBalloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
The balloon catheter is placed at the various arterial feeders of the tumor
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ballloon catheter
Arm Description
Balloon-assisted transarterial therapy will be performed in the first treatment session only
Outcomes
Primary Outcome Measures
The change in hemodynamics of arterial blood supply to HCC tumors
The change in number of feeding arteries
The change in the perfusion pattern of HCC tumors
The change in perfusion pressure.
Secondary Outcome Measures
Tumor response
Tumor response by CT such as complete response according to European Association for the Study of the Liver (EASL) necrosis guidelines.
Full Information
NCT ID
NCT04780802
First Posted
November 30, 2020
Last Updated
October 19, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04780802
Brief Title
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
Official Title
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma: a Study on the Proof of Treatment Concept and Exploration of Selection Criteria for Clinical Application
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ballloon catheter
Arm Type
Other
Arm Description
Balloon-assisted transarterial therapy will be performed in the first treatment session only
Intervention Type
Procedure
Intervention Name(s)
The balloon catheter is placed at the various arterial feeders of the tumor
Intervention Description
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 Outcome Measure Information:
Title
The change in hemodynamics of arterial blood supply to HCC tumors
Description
The change in number of feeding arteries
Time Frame
immediately after completion of procedure
Title
The change in the perfusion pattern of HCC tumors
Description
The change in perfusion pressure.
Time Frame
immediately after completion of procedure
Secondary Outcome Measure Information:
Title
Tumor response
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Yu, Professor
Organizational Affiliation
DIIR, CUHK, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
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