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

NCT03518502 | Unknown Phase 4 DMC

• 1 other identifier: 2012AS0313
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatocellular Carcinoma; Metastasis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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 Outcomes (3)

• Time to progression (TTP)

  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)

  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)

  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)

Study Arms (2)

Sorafenib monotherapy arm

ACTIVE COMPARATOR

The sorafenib monotherapy group receives sorafenib immediately after randomization.

Drug: Sorafenib

TACE-sorafenib sequential therapy arm

EXPERIMENTAL

TACE(transarterial chemoembolization )-sorafenib group receives 2\~4 times of TACE before starting sorafenib.

Procedure: transarterial chemoembolization (TACE); Drug: Sorafenib

Interventions

transarterial chemoembolization (TACE) PROCEDURE

Standard therapy for intermediate HCC, but nor for advanced HCC

TACE-sorafenib sequential therapy arm

Sorafenib DRUG

Standard therapy for advanced HCC

Sorafenib monotherapy arm; TACE-sorafenib sequential therapy arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University: lead
• Korean Liver Cancer Study Group: collaborator

Study Sites (6)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

RECRUITING

Soonchunghyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

RECRUITING

Chonnam National University Hwasoon Hospital

Gwangju, South Korea

RECRUITING

Seoul Saint Marry Hospital, the Catholic University of Korea

Seoul, South Korea

RECRUITING

Severance Hospital, Yonsei University

Seoul, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 12049862 RESULT

• 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.

  PMID: 11981766 RESULT

• 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.

  PMID: 12091661 RESULT

• 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.

  PMID: 12540794 RESULT

• 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.

  PMID: 18650514 RESULT

• 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.

  PMID: 19095497 RESULT

• 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.

  PMID: 21605146 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hyung Joon Yim, M.D.

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyung Joon Yim, M.D.

CONTACT

82-31-412-6565; gudwns21@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sorafenib monotherapy vs. transarterial chemoembolization-sorafenib sequential therapy

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 8, 2018
• Study Start: March 1, 2012
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2022
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)