Carcinoma, HepatocellularNCT03662841
Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
A study testing Ablative chemoembolization (ACE) in people with Carcinoma, Hepatocellular, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective of this study is to study the safety and tumor response of ACE for large HCC. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Ablative chemoembolization (ACE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Jul 2018to 28 Apr 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signage of a written informed consent
- Age above 18 years
- HCC unsuitable for resection
- Child-Pugh A or B cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
- 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 >10cm in largest dimension
Who cannot join
- 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
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- Serum total bilirubin level > 50 umol/L
- Serum albumin level < 25g/L
- INR > 1.7
- Serum creatinine level > 150 mmol/L.
- 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
The objective of this study is to study the safety and tumor response of ACE for large HCC.
Read the detailed description
Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size >10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size >10cm.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Ablative chemoembolization (ACE)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative chemoembolization (ACE)Procedure or surgery
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
| Study group | Role | What they receive |
|---|---|---|
| ACE for HCC of size >10cm | Other | Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin Receives: Procedure: Ablative chemoembolization (ACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression
Measured: 3 to 6 months after treatment
Secondary outcomes (1)
Tumor response
Tumor response at 3 month and 6 month from the date of first treatment as evaluated by triphasic contrast enhanced CT according to the EASL criteria
Measured: 3 to 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start13 Jul 2018
- Primary completion17 Apr 2023
- Study completion28 Apr 2023
Why it stopped: poor patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Model description
- Use of ACE for HCC of size \> 10cm
- Masking
- None (open label)
- Enrolment
- 11 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, Principal investigator, DIIR, CUHK, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662841
- Sponsor's protocol ID
- VIR-18-08
- Status last verified
- Feb 2022
- First submitted
- 6 Sep 2018
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03662841
- Acronym / sponsor ID
- VIR-18-08
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor patient accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 10 Sep 2018 (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.
The objective of this study is to study the safety and tumor response of ACE for large HCC.
Detailed description
Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size >10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size >10cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of ACE for HCC of size > 10cm
| Arm | Type | Receives |
|---|---|---|
| ACE for HCC of size >10cm | Other | Procedure: Ablative chemoembolization (ACE)Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signage of a written informed consent
- Age above 18 years
- HCC unsuitable for resection
- Child-Pugh A or B cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Ablative chemoembolization (ACE)Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin | Procedure or surgery | ACE for HCC of size >10cm |
Primary outcome
Time to progression
Time frame: 3 to 6 months after treatment
the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression
1 secondary outcome
Tumor response
Time frame: 3 to 6 months after treatment
Results and safety
The study was stopped early (reason given: poor patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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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 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 Ablative chemoembolization (ACE) in people with Carcinoma, Hepatocellular, 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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 3 May 2023. 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 was stopped early (reason given: poor patient accrual). Results are not available in the source record.
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?
Time to progression (time frame: 3 to 6 months after treatment). 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 3 May 2023.