- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796145
Fibroscan Study in HCC
November 13, 2025 updated by: CCTU, Chinese University of Hong Kong
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
207
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- ECOG performance status > 2
- Poorly controlled ascites
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TACE
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Experimental: Systemic Therapy
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Experimental: Surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate and grade of treatment complications
Time Frame: 2 years
|
2 years
|
|
Liver stiffness (kPa)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Lam Chan, FHKCP, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2013
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 20, 2013
First Submitted That Met QC Criteria
February 20, 2013
First Posted (Estimated)
February 21, 2013
Study Record Updates
Last Update Posted (Estimated)
November 17, 2025
Last Update Submitted That Met QC Criteria
November 13, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCC033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.