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

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ClinicalTrials.gov Identifier: NCT03518502
Recruitment Status : Unknown
Verified May 2018 by Hyung Joon Yim, Korea University.
Recruitment status was:  Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Korean Liver Cancer Study Group
Information provided by (Responsible Party):
Hyung Joon Yim, Korea University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Metastasis Procedure: transarterial chemoembolization (TACE) Drug: Sorafenib Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sorafenib monotherapy vs. transarterial chemoembolization-sorafenib sequential therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Between Sorafenib Monotherapy vs. Transarterial Chemoembolization -Sorafenib Sequential Therapy in Hepatocellular Carcinoma Patients With Extrahepatic Metastasis
Actual Study Start Date : March 1, 2012
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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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.
 Procedure: transarterial chemoembolization (TACE)
Standard therapy for intermediate HCC, but nor for advanced HCC

Drug: Sorafenib
Standard therapy for advanced HCC


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518502


Contacts
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Contact: Hyung Joon Yim, M.D. 82-31-412-6565 gudwns21@korea.ac.kr

Locations
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Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Contact: Hyung Joon Yim, M.D.    82-31-412-6565    gudwns21@korea.ac.kr   
Contact: Sang Jun Suh, M.D.    82-31-412-4926    mothpickle@naver.com   
Principal Investigator: Hyung Joon Yim, M.D.         
Sub-Investigator: Sang Jun Suh, M.D.         
Sub-Investigator: Young Kul Jung, M.D.         
Soonchunghyang University Bucheon Hospital Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of
Contact: Young-Seok Kim         
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of
Contact: Woo Jin Chung         
Chonnam National University Hwasoon Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Sung-Bum Cho, M.D.         
Seoul Saint Marry Hospital, the Catholic University of Korea Recruiting
Seoul, Korea, Republic of
Contact: Si-Hyun Bae         
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of
Contact: Jun Yong Park, M.D.         
Sponsors and Collaborators
Korea University
Korean Liver Cancer Study Group
Investigators
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Principal Investigator: Hyung Joon Yim, M.D. Korea University
More Information
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Publications of Results:

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Responsible Party: Hyung Joon Yim, Professor, Korea University
ClinicalTrials.gov Identifier: NCT03518502    
Other Study ID Numbers: 2012AS0313
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Neoplasm Metastasis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action