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

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transarterial radioembolization (TARE)
transarterial chemoembolization (TACE)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring transarterial chemoembolization, transarterial radioembolization, advanced hepatocellular carcinoma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The TARE group

The TACE group

Arm Description

transarterial radioembolization group

Transarterial chemoembolization group

Outcomes

Primary Outcome Measures

Overall survival
From date of randomization until the date of death

Secondary Outcome Measures

Progression-Free Survival in the Liver
From date of randomization until the date of first documented intrahepatic tumor progression or death
Progression-Free Survival Overall
From date of randomization until the date of first documented progression or death
Overall tumor response assessment
(CR, PR, SD, PD)by modified RECIST criteria

Full Information

First Posted
October 1, 2013
Last Updated
April 26, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02004210
Brief Title
A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma
Official Title
A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled.
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
transarterial chemoembolization, transarterial radioembolization, advanced hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The TARE group
Arm Type
Experimental
Arm Description
transarterial radioembolization group
Arm Title
The TACE group
Arm Type
Experimental
Arm Description
Transarterial chemoembolization group
Intervention Type
Procedure
Intervention Name(s)
transarterial radioembolization (TARE)
Intervention Description
transarterial radioembolization
Intervention Type
Procedure
Intervention Name(s)
transarterial chemoembolization (TACE)
Intervention Description
transarterial chemoembolization
Primary Outcome Measure Information:
Title
Overall survival
Description
From date of randomization until the date of death
Time Frame
every 12 weeks, up to the time of death, up to 12 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival in the Liver
Description
From date of randomization until the date of first documented intrahepatic tumor progression or death
Time Frame
every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
Title
Progression-Free Survival Overall
Description
From date of randomization until the date of first documented progression or death
Time Frame
every 12 weeks, up to the time of death or first documented progression, up to 12 months
Title
Overall tumor response assessment
Description
(CR, PR, SD, PD)by modified RECIST criteria
Time Frame
every 12 weeks, up to the time of death or 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hwan Yoon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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