Confirmed Diagnosis of Hepatocellular CarcinomaNCT01796145
Fibroscan Study in HCC
A study testing Fibroscan in people with Confirmed Diagnosis of Hepatocellular Carcinoma and Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Confirmed Diagnosis of Hepatocellular Carcinoma, Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, Child's A to C Cirrhosis
- What is being tested?
- Fibroscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Feb 2013to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of HCC
- Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery
- For TACE cohort, patients undergoing first cycle TACE are eligible.
- For systemic therapy cohort, patients undergoing first-line systemic therapy are eligible.
- For surgery cohort, patient undergoing surgery are eligible.
- Prior surgery or loco-ablative therapy (e.g. Radiofrequency ablation, microwave, percutaneous ethanol injection) is allowed
- Child's A to Child's C liver function
Who cannot join
- ECOG performance status > 2
- Poorly controlled ascites
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Hepatocellular Carcinoma
In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanOther
| Study group | Role | What they receive |
|---|---|---|
| TACE | Experimental | Not described Receives: Other: Fibroscan |
| Systemic Therapy | Experimental | Not described Receives: Other: Fibroscan |
| Surgery | Experimental | Not described Receives: Other: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (2)
Rate and grade of treatment complications
Measured: 2 years
Liver stiffness (kPa)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study start27 Feb 2013
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Confirmed Diagnosis of 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Stephen Lam Chan, FHKCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796145
- Sponsor's protocol ID
- HCC033
- Status last verified
- Nov 2025
- First submitted
- 20 Feb 2013
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01796145
- Acronym / sponsor ID
- HCC033
- Conditions
- Confirmed Diagnosis of Hepatocellular Carcinoma, Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, Child's A to C Cirrhosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 Feb 2013 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Feb 2013 (estimated)
- 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.
In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TACE | Experimental | Other: Fibroscan |
| Systemic Therapy | Experimental | Other: Fibroscan |
| Surgery | Experimental | Other: Fibroscan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of HCC
- Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery
- Prior surgery or loco-ablative therapy (e.g. Radiofrequency ablation, microwave, percutaneous ethanol injection) is allowed
- Child's A to Child's C liver function
Key exclusion criteria (2 listed)
- ECOG performance status > 2
- Poorly controlled ascites
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 |
|---|---|---|
| Fibroscan | Other | Surgery, Systemic Therapy, TACE |
Primary outcome
Overall survival
Time frame: 3 years
2 secondary outcomes
Rate and grade of treatment complications
Time frame: 2 years
Liver stiffness (kPa)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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.
Stephen Lam Chan, FHKCP principal investigator
Chinese University of 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 Fibroscan in people with Confirmed Diagnosis of Hepatocellular Carcinoma and Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: 3 years). 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 17 Nov 2025.