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Hepatocellular CarcinomaPhase 3TACEforHCCNCT00493402

Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

A Phase 3 study testing Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Transarterial chemoembolization (TACE)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
365 participants
Where
1 siteChina
Study dates
Jul 2007to Dec 2010
Phase
Phase 3
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

  • Adult patients with minimal height of 150cm and minimal weight of 50 KG
  • Histological confirmed HCC
  • with no previous treatment
  • With unresectable tumor
  • With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
  • No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
Show all 17Show fewer
  • No significant renal impairment (creatinine clearance < 30 mL/minute)
  • The following laboratory parameters:
  • Platelet count ≥ 60,000/µL
  • Hemoglobin ≥ 8.5 g/dL
  • Total bilirubin ≤ 1.5 mg/dL
  • ASL and AST ≤ 5 x upper limit of normal
  • Serum albumin ≥ 35 g/L
  • Serum creatinine ≤ 1.5 x upper limit of normal
  • INR ≤ 1.5 or a Pt/PTT within normal limits
  • Absolute neutrophil count (ANC) > 1,500/mm3
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Who cannot join

  • Avascular tumor
  • Main portal vein obstruction without cavernous transformation
  • Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
  • Obstructive jaundice
  • Severe underlying cardiac or renal diseases
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
Show all 10Show fewer
  • Pregnant or breast-feeding patients.
  • History of organ allograft
  • Active clinically serious infections
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).

Read the detailed description

Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.

Regimen 1: lipiodol combined chemotherapy with embolization

Regimen 2: lipiodol combined chemotherapy without embolization

Regimen 3: lipiodol single agent chemotherapy with embolization

Being tested
Transarterial chemoembolization (TACE)
Keywords
Antineoplastic Agents, administration & dosage, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Humans, Liver Neoplasms, therapy
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

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

    drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.

  • Transarterial chemoembolization (TACE)Procedure or surgery

    drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.

  • Transarterial chemoembolization (TACE)Procedure or surgery

    Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.

Study groups in NCT00493402
Study groupRoleWhat they receive
combined chemotherapy with embolizationExperimentalchemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization.
Receives: Procedure: Transarterial chemoembolization (TACE)
combined chemotherapy without embolizationExperimentalchemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization.
Receives: Procedure: Transarterial chemoembolization (TACE)
single agent chemotherapy with embolizationExperimentalchemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Receives: Procedure: Transarterial chemoembolization (TACE)

What is being measured

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

  1. Overall survival

    Measured: 3 years

Secondary outcomes (1)

  1. Time to progression

    Measured: 3 years

Timeline

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

  1. First posted28 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionDec 2010
  4. Study completionDec 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493402
Sponsor's protocol ID
hcc-001
Acronym
TACEforHCC
Status last verified
Dec 2012
First submitted
27 Jun 2007
Last updated
17 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16250051

  • BREEDIS C, YOUNG G. The blood supply of neoplasms in the liver. Am J Pathol. 1954 Sep-Oct;30(5):969-77. No abstract available.

    PubMed 13197542

  • 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

  • Ono Y, Yoshimasu T, Ashikaga R, Inoue M, Shindou H, Fuji K, Araki Y, Nishimura Y. Long-term results of lipiodol-transcatheter arterial embolization with cisplatin or doxorubicin for unresectable hepatocellular carcinoma. Am J Clin Oncol. 2000 Dec;23(6):564-8. doi: 10.1097/00000421-200012000-00006.

    PubMed 11202797

  • Lau WY, Yu SC, Lai EC, Leung TW. Transarterial chemoembolization for hepatocellular carcinoma. J Am Coll Surg. 2006 Jan;202(1):155-68. doi: 10.1016/j.jamcollsurg.2005.06.263. Epub 2005 Oct 19. No abstract available.

    PubMed 16377509

  • Lopez PM, Villanueva A, Llovet JM. Systematic review: evidence-based management of hepatocellular carcinoma--an updated analysis of randomized controlled trials. Aliment Pharmacol Ther. 2006 Jun 1;23(11):1535-47. doi: 10.1111/j.1365-2036.2006.02932.x.

    PubMed 16696801

  • Lai CL, Wu PC, Chan GC, Lok AS, Lin HJ. Doxorubicin versus no antitumor therapy in inoperable hepatocellular carcinoma. A prospective randomized trial. Cancer. 1988 Aug 1;62(3):479-83. doi: 10.1002/1097-0142(19880801)62:33.0.co;2-l.

    PubMed 2839280

  • Hong K, Georgiades CS, Geschwind JF. Technology insight: Image-guided therapies for hepatocellular carcinoma--intra-arterial and ablative techniques. Nat Clin Pract Oncol. 2006 Jun;3(6):315-24. doi: 10.1038/ncponc0512.

    PubMed 16757969

  • Trevisani F, De Notariis S, Rossi C, Bernardi M. Randomized control trials on chemoembolization for hepatocellular carcinoma: is there room for new studies? J Clin Gastroenterol. 2001 May-Jun;32(5):383-9. doi: 10.1097/00004836-200105000-00005.

    PubMed 11319307

  • Kajanti M, Pyrhonen S, Mantyla M, Rissanen P. Intra-arterial and intravenous use of 4' epidoxorubicin combined with 5-fluorouracil in primary hepatocellular carcinoma. A randomized comparison. Am J Clin Oncol. 1992 Feb;15(1):37-40. doi: 10.1097/00000421-199202000-00008.

    PubMed 1312770

  • Heresbach D, Raoul JL, Bentue-Ferrer D, Bretagne JF, Van den Driessche J, Gastard J. [Chemotherapy combined with Lipiodol. In vitro study of the kinetics of release of adriamycin]. Gastroenterol Clin Biol. 1989 Oct;13(10):775-8. French.

    PubMed 2556315

  • Higashi S, Shimizu M, Nakashima T, Iwata K, Uchiyama F, Tateno S, Tamura S, Setoguchi T. Arterial-injection chemotherapy for hepatocellular carcinoma using monodispersed poppy-seed oil microdroplets containing fine aqueous vesicles of epirubicin. Initial medical application of a membrane-emulsification technique. Cancer. 1995 Mar 15;75(6):1245-54. doi: 10.1002/1097-0142(19950315)75:63.0.co;2-u.

    PubMed 7882276

  • Raoul JL, Heresbach D, Bretagne JF, Ferrer DB, Duvauferrier R, Bourguet P, Messner M, Gosselin M. Chemoembolization of hepatocellular carcinomas. A study of the biodistribution and pharmacokinetics of doxorubicin. Cancer. 1992 Aug 1;70(3):585-90. doi: 10.1002/1097-0142(19920801)70:33.0.co;2-#.

    PubMed 1320447

  • Kasugai H, Kojima J, Tatsuta M, Okuda S, Sasaki Y, Imaoka S, Fujita M, Ishiguro S. Treatment of hepatocellular carcinoma by transcatheter arterial embolization combined with intraarterial infusion of a mixture of cisplatin and ethiodized oil. Gastroenterology. 1989 Oct;97(4):965-71. doi: 10.1016/0016-5085(89)91505-9.

    PubMed 2550311

  • Nakao N, Uchida H, Kamino K, Nishimura Y, Ohishi H, Takayasu Y, Miura K. Determination of the optimum dose level of lipiodol in transcatheter arterial embolization of primary hepatocellular carcinoma based on retrospective multivariate analysis. Cardiovasc Intervent Radiol. 1994 Mar-Apr;17(2):76-80. doi: 10.1007/BF00193921.

    PubMed 8013027

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

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 17 inclusion and 10 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: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 3 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 NCT00493402, which also lists 28 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 17 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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