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

April 27, 2016 updated by: Jung-Hwan Yoon, Seoul National University Hospital

A Randomized Open Label Pilot Study Comparing Transarterial Chemoembolization Versus Transarterial Chemoembolization/Transarterial Chemoinfusion Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

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.

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Withdrawn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. 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.

Study Type

Interventional

Phase

  • Not Applicable

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

18 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 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

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The TACE/TACI combination group
Transarterial chemoembolization with doxorubicin/transarterial chemoinfusion with cisplatin combination
Drug: Doxorubicin
Transarterial chemoembolization (TACE) with adriamycin
Other Names:
  • Adriamycin
Drug: Cisplatin
transarterial chemoinfusion with cisplatin 50-100 mg
Active Comparator: The TACE-only group
Transarterial chemoembolization with doxorubicin
Drug: Doxorubicin
Transarterial chemoembolization (TACE) with adriamycin
Other Names:
  • Adriamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: every 12 weeks, up to 48 weeks
every 12 weeks, up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-to-progression
Time Frame: every 12 weeks, up to 48 weeks
every 12 weeks, up to 48 weeks
Progression-free survival
Time Frame: every 12 weeks, up to 48 weeks
every 12 weeks, up to 48 weeks

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

July 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT_TACE/TACI

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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