NCT01796145

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2013Dec 2027

First Submitted

Initial submission to the registry

February 20, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

February 27, 2013

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

13.8 years

First QC Date

February 20, 2013

Last Update Submit

November 13, 2025

Conditions

Confirmed Diagnosis of Hepatocellular CarcinomaPatients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy SurgeryChild's A to C Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (2)

  • Rate and grade of treatment complications

    2 years

  • Liver stiffness (kPa)

    2 years

Study Arms (3)

TACE

EXPERIMENTAL
Other: Fibroscan

Systemic Therapy

EXPERIMENTAL
Other: Fibroscan

Surgery

EXPERIMENTAL
Other: Fibroscan

Interventions

FibroscanOTHER
SurgerySystemic TherapyTACE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ECOG performance status \> 2
  • Poorly controlled ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Study Officials

  • Stephen Lam Chan, FHKCP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comprehensive Cancer Trials Unit

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 21, 2013

Study Start

February 27, 2013

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

HK(1)