NCT01512407

Brief Summary

We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

7.5 years

First QC Date

January 14, 2012

Last Update Submit

March 5, 2022

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaRandomised controlled trialTransarterial chemoembolisation

Outcome Measures

Primary Outcomes (1)

  • 1-year recurrence rate

    The 1-year recurrence rate after hepatectomy in both arms of study were compared

    1-year after hepatectomy

Secondary Outcomes (4)

  • Disease-free survival

    5 years after operation

  • Overall Survival

    5-year after surgery

  • Complications of transarterial chemoembolisation

    3-month after transarterial chemoembolisation

  • Health-related quality of life assessment

    1-year after surgery

Study Arms (2)

Hepatectomy plus TACE

EXPERIMENTAL

Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy

Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture

Hepatectomy alone

NO INTERVENTION

Interventions

Transarterial chemoembolisation using cisplatin-lipiodol mixturePROCEDURE

Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery

Hepatectomy plus TACE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCC patients received curative hepatectomy with negative resection margin
  • Age from 18 to 70
  • Child-Pugh class A
  • ASA class I to III
  • ECOG performance status Grade 0 or 1

You may not qualify if:

  • Patients receiving concomitant local ablation or previous TACE
  • Main portal vein tumour thrombus extraction during hepatectomy
  • Tumour arising from caudate lobe
  • Presence of extra-hepatic disease
  • Very early HCC with solitary tumour and size \< 2cm
  • Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \< 25g/L or bilirubin \> 50micromol/L
  • Renal impairment with creatinine \> 200micromol/L
  • Severe concurrent medical illness persisting \> 6 weeks after hepatectomy
  • History of other cancer
  • Hepatic artery anomaly making TACE not possible
  • Allergy to cisplatin or lipiodol
  • Pregnant woman
  • Informed consent not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Yue Sun Cheung, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Cheung Yue Sun

Study Record Dates

First Submitted

January 14, 2012

First Posted

January 19, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2019

Study Completion

December 1, 2019

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

CN(1)