A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

April 26, 2016 updated by: Jung-Hwan Yoon, Seoul National University Hospital

A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
    • 2-5 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
    • Bilirubin ≦ 3 mg/dL
    • Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The TARE group
transarterial radioembolization group
Procedure: transarterial radioembolization (TARE)
transarterial radioembolization
EXPERIMENTAL: The TACE group
Transarterial chemoembolization group
Procedure: transarterial chemoembolization (TACE)
transarterial chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: every 12 weeks, up to the time of death, up to 12 months
From date of randomization until the date of death
every 12 weeks, up to the time of death, up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival in the Liver
Time Frame: every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
From date of randomization until the date of first documented intrahepatic tumor progression or death
every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
Progression-Free Survival Overall
Time Frame: every 12 weeks, up to the time of death or first documented progression, up to 12 months
From date of randomization until the date of first documented progression or death
every 12 weeks, up to the time of death or first documented progression, up to 12 months
Overall tumor response assessment
Time Frame: every 12 weeks, up to the time of death or 12 months
(CR, PR, SD, PD)by modified RECIST criteria
every 12 weeks, up to the time of death or 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

October 1, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (ESTIMATE)

December 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACE_TARE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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