Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis

May 6, 2018 updated by: Hyung Joon Yim, Korea University

Comparison of Efficacy Between Sorafenib Monotherapy vs. Transarterial Chemoembolization -Sorafenib Sequential Therapy in Hepatocellular Carcinoma Patients With Extrahepatic Metastasis

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, addition of transarterial chemoembolization (TACE) may be beneficial for controlling intrahepatic tumour. The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Sorafenib is the standard therapy for hepatocellular carcinoma (HCC) with extrahepatic metastasis (EHM). However, transarterial chemoembolization (TACE) which is a standard therapy for intermediate stage may be beneficial for controlling intrahepatic tumour, thereby providing chance of improving survival in HCC patients with EHM.

The investigators aimed to compare the efficacy between the sorafenib monotherapy and TACE-sorafenib sequential therapy in HCC patients with EHM.

This study is a prospective randomized controlled study being conducted at 6 tertiary hospitals in South Korea. HCC patients with EHM are being enrolled and randomized into sorafenib monotherapy or TACE-sorafenib sequential therapy group. Patients with main portal vein invasion, Child-Pugh class B or C, and history of TACE or previous systemic therapy are being excluded. The sorafenib monotherapy group receives sorafenib immediately after randomization while the TACE-sorafenib group receives 2~4 times of TACE before starting sorafenib. Response evaluation are performed every 2 months, and time to progression (TTP), progression free survival (PFS), median survival time (MST), and overall survival (OS) which is the primary outcome measure will be compared.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

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

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
          • Woo Jin Chung
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hwasoon Hospital
        • Contact:
          • Sung-Bum Cho, M.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital, Yonsei University
        • Contact:
          • Jun Yong Park, M.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Saint Marry Hospital, the Catholic University of Korea
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 425-707
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyung Joon Yim, M.D.
        • Sub-Investigator:
          • Sang Jun Suh, M.D.
        • Sub-Investigator:
          • Young Kul Jung, M.D.
      • Bucheon, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Soonchunghyang University Bucheon Hospital
        • Contact:
          • Young-Seok Kim

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with hepatocellular carcinoma by the European Association for the Study of the Liver (EASL) criteria or pathology
  • One or more extrahepatic metastatic lesion by proven radiologically or histologically
  • No serious coagulation abnormalities
  • Performance status 0 or 1 by Eastern Cooperative Oncology Group(ECOG) criteria
  • Child-Pugh score 5 or 6
  • Serum creatinine <1.5mg/dL
  • Age between 18 ~ 75 years old
  • No other life-threatening medical illness

Exclusion Criteria:

  • Patients with main portal vein invasion
  • Child-Pugh class B or C
  • History of TACE or previous systemic chemotherapy including sorafenib
  • Age >75 years old
  • Cardiovascular diseases
  • History of gastrointestinal bleeding within 2 weeks

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
ACTIVE_COMPARATOR: Sorafenib monotherapy arm
The sorafenib monotherapy group receives sorafenib immediately after randomization.
Drug: Sorafenib
Standard therapy for advanced HCC
EXPERIMENTAL: TACE-sorafenib sequential therapy arm
TACE(transarterial chemoembolization )-sorafenib group receives 2~4 times of TACE before starting sorafenib.
Drug: Sorafenib
Standard therapy for advanced HCC
Procedure: transarterial chemoembolization (TACE)
Standard therapy for intermediate HCC, but nor for advanced HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Survival rate during the study period
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression (TTP)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Time form the enrollment to the event of progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Progression free survival (PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Survival rate without progression of HCC
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Median survival time (MST)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)
Median time of the patient survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to Feb 28, 2020 (maxium duration: up to 8 years)

Collaborators and Investigators

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

Sponsor

Korea University

Collaborators

Korean Liver Cancer Study Group

Investigators

  • Principal Investigator: Hyung Joon Yim, M.D., Korea University Ansan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

March 1, 2012

Primary Completion (ANTICIPATED)

February 28, 2020

Study Completion (ANTICIPATED)

February 28, 2022

Study Registration Dates

First Submitted

April 21, 2018

First Submitted That Met QC Criteria

May 6, 2018

First Posted (ACTUAL)

May 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 6, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012AS0313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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