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Hepatocellular CarcinomaPhase 4NCT03518502

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

A Phase 4 study testing transarterial chemoembolization (TACE) and Sorafenib in people with Hepatocellular Carcinoma and Metastasis, run by Korea University at 6 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma, Metastasis
What is being tested?
transarterial chemoembolization (TACE) and Sorafenib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
6 sitesSouth Korea
Study dates
1 Mar 2012to 28 Feb 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

Hyung Joon Yim, M.D. contact

82-31-412-6565

gudwns21@korea.ac.kr

6 sites in 1 country

South Korea6 sites, 6 recruiting

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 425-707

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

    Sang Jun Suh, M.D., 82-31-412-4926, mothpickle@naver.com

    Recruiting

  • Soonchunghyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do

    Young-Seok Kim

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu

    Woo Jin Chung

    Recruiting

  • Chonnam National University Hwasoon Hospital

    Gwangju

    Sung-Bum Cho, M.D.

    Recruiting

  • Seoul Saint Marry Hospital, the Catholic University of Korea

    Seoul

    Si-Hyun Bae

    Recruiting

  • Severance Hospital, Yonsei University

    Seoul

    Jun Yong Park, M.D.

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
transarterial chemoembolization (TACE), Sorafenib
Medical subject headings
Carcinoma, Hepatocellular, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transarterial chemoembolization (TACE)Procedure or surgery

    Standard therapy for intermediate HCC, but nor for advanced HCC

  • SorafenibDrug

    Standard therapy for advanced HCC

Study groups in NCT03518502
Study groupRoleWhat they receive
Sorafenib monotherapy armActive comparatorThe sorafenib monotherapy group receives sorafenib immediately after randomization.
Receives: Drug: Sorafenib
TACE-sorafenib sequential therapy armExperimentalTACE(transarterial chemoembolization )-sorafenib group receives 2~4 times of TACE before starting sorafenib.
Receives: Procedure: transarterial chemoembolization (TACE); Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Survival rate during the study period

    Measured: 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 outcomes (3)

  1. Time to progression (TTP)

    Time form the enrollment to the event of progression

    Measured: 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)

  2. Progression free survival (PFS)

    Survival rate without progression of HCC

    Measured: 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)

  3. Median survival time (MST)

    Median time of the patient survival

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start1 Mar 2012
  3. Primary completion28 Feb 2020 (estimated)
  4. Study completion28 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sorafenib monotherapy vs. transarterial chemoembolization-sorafenib sequential therapy
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518502
Sponsor's protocol ID
2012AS0313
Status last verified
May 2018
First submitted
21 Apr 2018
Last updated
8 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.

    PubMed 12049862

  • Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.

    PubMed 11981766

  • Camma C, Schepis F, Orlando A, Albanese M, Shahied L, Trevisani F, Andreone P, Craxi A, Cottone M. Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials. Radiology. 2002 Jul;224(1):47-54. doi: 10.1148/radiol.2241011262.

    PubMed 12091661

  • Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.

    PubMed 12540794

  • Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

    PubMed 18650514

  • Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.

    PubMed 19095497

  • Cabrera R, Pannu DS, Caridi J, Firpi RJ, Soldevila-Pico C, Morelli G, Clark V, Suman A, George TJ Jr, Nelson DR. The combination of sorafenib with transarterial chemoembolisation for hepatocellular carcinoma. Aliment Pharmacol Ther. 2011 Jul;34(2):205-13. doi: 10.1111/j.1365-2036.2011.04697.x. Epub 2011 May 23.

    PubMed 21605146

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing transarterial chemoembolization (TACE) and Sorafenib in people with Hepatocellular Carcinoma and Metastasis, run by Korea University at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyung Joon Yim, M.D. (82-31-412-6565, gudwns21@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518502, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.

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