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Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Doxorubicin
Cisplatin
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 hepatocellular carcinoma, portal vein invasion, transarterial chemoembolization, transarterial chemoinfusion

Eligibility Criteria

18 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 invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
  • Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
  • Age : 18 years to 80 years
  • ECOG Performance Status of 0 to 2
  • Child-Pugh class A (Child-Pugh score 5-6)

  • Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

    • WBC count > 2,000/mm3
    • Absolute neutrophil count > 1,000/mm3
    • Hb ≧ 8.0 g/dL
    • Platelet count ≧ 50,000 /mm3
    • Bilirubin ≦ 3 mg/dL
    • Adequate clotting function: INR < 2.3 or < 6sec

Exclusion Criteria:

  • Child-Pugh score ≧ 7
  • 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 with extrahepatic metastasis

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The TACE/TACI combination group

The TACE-only group

Arm Description

Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination

Transarterial chemoembolization with doxorubicin

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Time-to-progression
Progression-free survival

Full Information

First Posted
May 13, 2013
Last Updated
April 27, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01857726
Brief Title
Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Official Title
A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (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 transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.
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. Especially, HCCs with portal vein invasion are unresectable and they 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 and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients. The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, portal vein invasion, transarterial chemoembolization, transarterial chemoinfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The TACE/TACI combination group
Arm Type
Experimental
Arm Description
Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination
Arm Title
The TACE-only group
Arm Type
Active Comparator
Arm Description
Transarterial chemoembolization with doxorubicin
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
Transarterial chemoembolization (TACE) with adriamycin
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
transarterial chemoinfusion with cisplatin 50-100 mg
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
every 12 weeks, up to 48 weeks
Secondary Outcome Measure Information:
Title
Time-to-progression
Time Frame
every 12 weeks, up to 48 weeks
Title
Progression-free survival
Time Frame
every 12 weeks, up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible Age : 18 years to 80 years ECOG Performance Status of 0 to 2 Child-Pugh class A (Child-Pugh score 5-6) Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: WBC count > 2,000/mm3 Absolute neutrophil count > 1,000/mm3 Hb ≧ 8.0 g/dL Platelet count ≧ 50,000 /mm3 Bilirubin ≦ 3 mg/dL Adequate clotting function: INR < 2.3 or < 6sec Exclusion Criteria: Child-Pugh score ≧ 7 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 with extrahepatic metastasis
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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Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

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