Hepatocellular CarcinomaNCT04780802
Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma
A study testing The balloon catheter is placed at the various arterial feeders of the tumor in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To prove the treatment concept of the use of balloon assistance in transarterial therapy for HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- The balloon catheter is placed at the various arterial feeders of the tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- The balloon catheter is placed at the various arterial feeders of the tumor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The balloon catheter is placed at the various arterial feeders of the tumorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ballloon catheter | Other | Balloon-assisted transarterial therapy will be performed in the first treatment session only Receives: Procedure: The balloon catheter is placed at the various arterial feeders of the tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in hemodynamics of arterial blood supply to HCC tumors
The change in number of feeding arteries
Measured: immediately after completion of procedure
The change in the perfusion pattern of HCC tumors
The change in perfusion pressure.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 May 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon Yu, Professor, Principal investigator, DIIR, CUHK, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780802
- Sponsor's protocol ID
- VIR-20-13
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2020
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04780802
- Acronym / sponsor ID
- VIR-20-13
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ballloon catheter | Other | Procedure: The balloon catheter is placed at the various arterial feeders of the tumorBalloon-assisted transarterial therapy will be performed in the first treatment session only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The balloon catheter is placed at the various arterial feeders of the tumoruse 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. | Procedure or surgery | Ballloon catheter |
Primary outcome
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
The change in the perfusion pattern of HCC tumors
Time frame: immediately after completion of procedure
The change in perfusion pressure.
1 secondary outcome
Tumor response
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Yu, Professor principal investigator
DIIR, CUHK, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The balloon catheter is placed at the various arterial feeders of the tumor in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in hemodynamics of arterial blood supply to HCC tumors (time frame: immediately after completion of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.