A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Unresectable Hepatocellular Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Confirmed Diagnosis of HCC;, Patients Who Are Scheduled to Undergo TACE or Systemic Therapy;, Child's A or B Cirrhosis.
Both
Confirmed Diagnosis of HCC;, Patients Who Are Scheduled to Undergo TACE or Systemic Therapy;, Child's A or B Cirrhosis.
Trial Information
A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Unresectable Hepatocellular Carcinoma
Inclusion Criteria:
- Clinical diagnosis of inoperable HCC
- Patients who are scheduled to undergo non-surgical therapy, either TACE or systemic
therapy
1. For TACE cohort, patients undergoing first cycle TACE are eligible.
2. For systemic therapy cohort, patients undergoing first-line systemic therapy are
eligible.
- Prior surgery or loco-ablative therapy (e.g. Radiofrequency ablation, microwave,
percutaneous ethanol injection) is allowed
- Child's A or Child's B liver function
Exclusion Criteria:
- Child's C liver function
- ECOG performance status > 2
- Poorly controlled ascites
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Overall survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Stephen Lam Chan, FHKCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chinese University of Hong Kong
Authority:
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study ID:
HCC033
NCT ID:
NCT01796145
Start Date:
February 2013
Completion Date:
February 2016
Related Keywords:
- Confirmed Diagnosis of HCC;
- Patients Who Are Scheduled to Undergo TACE or Systemic Therapy;
- Child's A or B Cirrhosis.
- Fibrosis
- Carcinoma, Hepatocellular
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