NCT02004210

Brief Summary

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Typical duration for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

October 1, 2013

Last Update Submit

April 26, 2016

Conditions

Hepatocellular Carcinoma

Keywords

transarterial chemoembolizationtransarterial radioembolizationadvanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    From date of randomization until the date of death

    every 12 weeks, up to the time of death, up to 12 months

Secondary Outcomes (3)

  • Progression-Free Survival in the Liver

    every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months

  • Progression-Free Survival Overall

    every 12 weeks, up to the time of death or first documented progression, up to 12 months

  • Overall tumor response assessment

    every 12 weeks, up to the time of death or 12 months

Study Arms (2)

The TARE group

EXPERIMENTAL

transarterial radioembolization group

Procedure: transarterial radioembolization (TARE)

The TACE group

EXPERIMENTAL

Transarterial chemoembolization group

Procedure: transarterial chemoembolization (TACE)

Interventions

transarterial radioembolization (TARE)PROCEDURE

transarterial radioembolization

The TARE group
transarterial chemoembolization (TACE)PROCEDURE

transarterial chemoembolization

The TACE group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
  • Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
  • Patients with single large HCC or multinodular HCC
  • Single \& 5cm \< size \< 15cm
  • nodules \& maximal sized 4-15cm \& sum of diameters ≦ 25cm
  • Infiltrative type \& unilobular involvement on liver MRI
  • Segmental or lobar portal vein invasion can be included.
  • Age : 20 years to 80 years
  • ECOG Performance Status of 0 to 2
  • Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
  • Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • WBC count ≧ 1,000/mm3
  • Absolute neutrophil count \> 500/mm3
  • Hb ≧ 7.0 g/dL
  • Platelet count \> 100,000 /mm3
  • +2 more criteria

You may not qualify if:

  • Child-Pugh score ≧ 8
  • ECOG Performance Status ≧ 3
  • Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
  • History of organ allograft
  • Patients with uncontrolled co-morbidity which needs treatment
  • Patients who have received prior systemic chemotherapy
  • Patients who have received Capecitabine within 8 weeks
  • Patients with extrahepatic metastasis
  • Main portal vein invasion
  • Patients with lymph node metastasis
  • Bilobar involvement
  • Bulk disease(Tumor volume \>70% of the target liver volume, or tumor nodules too numerous to count)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

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

  • Jung-Hwan Yoon, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2013

First Posted

December 9, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

KR(1)