Drug-eluting Bead in Hepatocellular Carcinoma

NCT01332669 | Completed Phase 4 DMC

• 1 other identifier: Biocompatible-Korea
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In unresectable hepatocellular carcinoma, TACE using Lipiodol/anti cancer agent emulsion is the standard treatment and reported as a significantly better treatment through randomized comparison study like Llovet, etc. than conservative treatment. Recently, doctors do transarterial chemoembolization with drug-eluting bead, and it is proved less side effect and better efficacy than conventional TACE using Lipiodol in Precision V study by Dr. Lammer, etc. But, it could not defined improved survival rate as expected. This study's purpose is evaluating treatment efficacy, survival rate and safety of TACE using drug eluting bead by comparing to conventional TACE using doxorubicin/Lipiodol emulsion for unresectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; chemoembolization; drug eluting beads; HCC; Liver cancer; Korea

Outcome Measures

Primary Outcomes (1)

• tumor response

  6 months

Secondary Outcomes (5)

• survival rate

  2 years

• Incidence rate and grade of side effect

  6months

• Time to progression

  2 years

• Time to untreatable progression

  2 years

• Number of treatment required to achieve objective response

  6 months

Study Arms (2)

chemoembolization

ACTIVE COMPARATOR

HCC patients received chemoembolization

Procedure: DebDox TACE

Historical use of c-TACE using Lipiodiol and doxorubicin

OTHER

The control arm will be of the patients that have been treated historically in the centers with conventional TACE (that is Lipiodiol plus doxorubicin).

Procedure: DebDox TACE

Interventions

DebDox TACE PROCEDURE

HCC patients will receive chemoembolization (TACE) using DC beads containing Doxorubicin. The objective is to give 2 vials of DC Bead (2ml per vial) loaded with 70-75mg of Doxorubicin per vial (Each vial contain 2ml of DC Bead, thus doxorubicin concentration will be of 35-37.5mg per ml of DC Beads)

Also known as: chemoembolization using drug eluting beads, DC bead chemoembolization, DebDox, TACE

Historical use of c-TACE using Lipiodiol and doxorubicin; chemoembolization

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed diagnosis of HCC as stated below
• Cirrhotic subjects: Clinical diagnosis by AASLD criteria
• Non-cirrhotic subjects: histological confirmation is mandatory
• Patient with HCC not suitable for radical therapies such as resection, liver transplantation or percutaneous therapies or patient is indicated for these therapies but there is a contraindication for them or patient himself rejects above treatments and wants to do TACE (Indication for hepatectomy, liver transplantation, local ablation is decided by doctors of each center)
• Multinodular or single nodular tumor over 5cm, (In the case of single nodule less than 5cm, if curative treatment is contraindicated or the patient rejects curative treatment)
• Hypervascular lesion showing contrast enhancement in the early stage at the contrast media bolus injection CT or MRI.
• At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by CT-scan or MRI
• No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the CT or MR
• Eastern Cooperative Oncology Group performance status is 0 - 1
• Child-Pugh classification is A or B7
• Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study is followed:
• white blood cell number : \> 3,000/mm2
• platelet number : \> 5 x 104/mm3
• blood bilirubin : \< 3.0 mg/dL
• ASL, ALT is within 5 times of normal range of each organ

You may not qualify if:

• ECOG performance status 2 or more, Child-Pugh class B8 or more
• Diffuse HCC or presence of vascular or biliary invasion or extrahepatic spread.
• Vascular or biliary invasion
• Extrahepatic metastasis (Any lymph nodes measuring ≥ 10mm along the short axis)
• Tumor burden involving more than 50% of the liver
• Patients previously treated with any anti-cancer therapy for HCC except hepatic resection or early recurrence within 1 year after resection
• Liver cancer rupture
• History of biliary tract repair or endoscopic biliary tract treatment
• Clinically important refractory ascites or pleural fluid
• Any contraindications for hepatic embolization procedures
• Known hepatofugal blood flow
• Arterio-venous shunt
• Impaired clotting test (platelet count \< 5 x 104/mm3, PT-INR \> 2.0)
• Any contraindication for doxorubicin administration
• Contrast media allergy contraindicating angiography

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (11)

• Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocelluar carcinoma (HCC). J Surg Oncol. 2010 May 1;101(6):476-80. doi: 10.1002/jso.21522.

  PMID: 20213741 BACKGROUND

• Malagari K, Pomoni M, Kelekis A, Pomoni A, Dourakis S, Spyridopoulos T, Moschouris H, Emmanouil E, Rizos S, Kelekis D. Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2010 Jun;33(3):541-51. doi: 10.1007/s00270-009-9750-0. Epub 2009 Nov 24.

  PMID: 19937027 BACKGROUND

• Malagari K, Pomoni M, Spyridopoulos TN, Moschouris H, Kelekis A, Dourakis S, Alexopoulou E, Koskinas J, Angelopoulos M, Kornezos J, Pomoni A, Tandeles S, Marinis A, Rizos S, Kelekis D. Safety profile of sequential transcatheter chemoembolization with DC Bead: results of 237 hepatocellular carcinoma (HCC) patients. Cardiovasc Intervent Radiol. 2011 Aug;34(4):774-85. doi: 10.1007/s00270-010-0044-3. Epub 2010 Dec 24.

  PMID: 21184228 BACKGROUND

• Nicolini A, Martinetti L, Crespi S, Maggioni M, Sangiovanni A. Transarterial chemoembolization with epirubicin-eluting beads versus transarterial embolization before liver transplantation for hepatocellular carcinoma. J Vasc Interv Radiol. 2010 Mar;21(3):327-32. doi: 10.1016/j.jvir.2009.10.038. Epub 2010 Jan 22.

  PMID: 20097098 BACKGROUND

• Poon RT, Tso WK, Pang RW, Ng KK, Woo R, Tai KS, Fan ST. A phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting bead. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1100-8. doi: 10.1016/j.cgh.2007.04.021. Epub 2007 Jul 12.

  PMID: 17627902 BACKGROUND

• Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, Pitton M, Sergent G, Pfammatter T, Terraz S, Benhamou Y, Avajon Y, Gruenberger T, Pomoni M, Langenberger H, Schuchmann M, Dumortier J, Mueller C, Chevallier P, Lencioni R; PRECISION V Investigators. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010 Feb;33(1):41-52. doi: 10.1007/s00270-009-9711-7. Epub 2009 Nov 12.

  PMID: 19908093 BACKGROUND

• Takayasu K, Arii S, Ikai I, Omata M, Okita K, Ichida T, Matsuyama Y, Nakanuma Y, Kojiro M, Makuuchi M, Yamaoka Y; Liver Cancer Study Group of Japan. Prospective cohort study of transarterial chemoembolization for unresectable hepatocellular carcinoma in 8510 patients. Gastroenterology. 2006 Aug;131(2):461-9. doi: 10.1053/j.gastro.2006.05.021.

  PMID: 16890600 BACKGROUND

• Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

  PMID: 18477802 BACKGROUND

• Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

  PMID: 16250051 BACKGROUND

• Varela M, Real MI, Burrel M, Forner A, Sala M, Brunet M, Ayuso C, Castells L, Montana X, Llovet JM, Bruix J. Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics. J Hepatol. 2007 Mar;46(3):474-81. doi: 10.1016/j.jhep.2006.10.020. Epub 2006 Nov 29.

  PMID: 17239480 BACKGROUND

• 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 BACKGROUND

Related Links

• efficacy of DEB in chemoembolization of HCC
• interventional treatment of HCC

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jin Wook Chung, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of radiology

Study Record Dates

• First Submitted: February 6, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2015
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

KR (1)