Sorafenib Monotherapy vs. TACE-sorafenib Sequential Therapy for HCC With Metastasis
NCT ID: NCT03518502
Last Updated: 2018-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
130 participants
INTERVENTIONAL
2012-03-01
2022-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sorafenib monotherapy arm
The sorafenib monotherapy group receives sorafenib immediately after randomization.
Sorafenib
Standard therapy for advanced HCC
TACE-sorafenib sequential therapy arm
TACE(transarterial chemoembolization )-sorafenib group receives 2\~4 times of TACE before starting sorafenib.
transarterial chemoembolization (TACE)
Standard therapy for intermediate HCC, but nor for advanced HCC
Sorafenib
Standard therapy for advanced HCC
Interventions
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transarterial chemoembolization (TACE)
Standard therapy for intermediate HCC, but nor for advanced HCC
Sorafenib
Standard therapy for advanced HCC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Korean Liver Cancer Study Group
OTHER
Korea University
OTHER
Responsible Party
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Hyung Joon Yim
Professor
Principal Investigators
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Hyung Joon Yim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Ansan Hospital
Locations
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Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Soonchunghyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Chonnam National University Hwasoon Hospital
Gwangju, , South Korea
Seoul Saint Marry Hospital, the Catholic University of Korea
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Young-Seok Kim
Role: primary
Woo Jin Chung
Role: primary
Sung-Bum Cho, M.D.
Role: primary
Si-Hyun Bae
Role: primary
Jun Yong Park, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2012AS0313
Identifier Type: -
Identifier Source: org_study_id
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