NCT01966133

Brief Summary

Investigators 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 of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor undergoing liver resection plus post-operative TACE versus liver resection alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2011

Typical duration for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

5 years

First QC Date

October 16, 2013

Last Update Submit

January 6, 2017

Conditions

Hepatocellular Carcinoma

Keywords

HCCRandomised controlled trialTACEResection

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    3 years after operation

Secondary Outcomes (2)

  • Overall Survival

    3-year after surgery

  • Complications of transarterial chemoembolisation

    3-month after transarterial chemoembolisation

Other Outcomes (1)

  • Health-related quality of life assessment

    1-year after surgery

Study Arms (2)

Control

NO INTERVENTION

no interventions were assigned

TACE('Ethiodized Oil + Doxorubicin)

ACTIVE COMPARATOR

TACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery.

Drug: Ethiodized Oil + Doxorubicin

Interventions

Ethiodized Oil + DoxorubicinDRUG

TACE using doxorubicin-lipiodol mixture

Also known as: doxorubicin-lipiodol mixture
TACE('Ethiodized Oil + Doxorubicin)

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
  • Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification.
  • 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
  • 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 doxorubicin or lipiodol
  • Pregnant woman
  • Informed consent not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Ethiodized OilDoxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Iodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex MixturesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Jia Fan, MD

    Liver cancer institute, Fudan university

    PRINCIPAL INVESTIGATOR

  • Jian Zhou, MD

    Liver Cancer Institute, Zhong Shan Hospital, Fudan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President of zhongshan hospital, Fudan University

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 21, 2013

Study Start

August 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

CN(1)