NCT00652587

Brief Summary

The purpose of this study is to evaluate whether hepatectomy combining with adjuvant transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC) resulting better long-term survival outcome when compared with hepatectomy alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2002

Typical duration for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

April 3, 2008

Status Verified

March 1, 2008

Enrollment Period

5.9 years

First QC Date

March 31, 2008

Last Update Submit

March 31, 2008

Conditions

Hepatocellular CarcinomaHepatectomyChemoembolization

Keywords

hepatocellular carcinomahepatectomychemoembolizationrandomized controlled trialprognosis

Outcome Measures

Primary Outcomes (1)

  • overall survival rates

    1-, 3-, and 5-year

Study Arms (2)

A, LRTACE

EXPERIMENTAL

hepatectomy with adjuvant transcatheter arterial chemoembolization

Procedure: hepatectomy and transcatheter arterial chemoembolization

B, LR

ACTIVE COMPARATOR

hepatectomy alone

Procedure: hepatectomy

Interventions

hepatectomy and transcatheter arterial chemoembolizationPROCEDURE

partial hepatectomy with adjuvant transcatheter arterial chemoembolization

A, LRTACE
hepatectomyPROCEDURE

hepatectomy alone

Also known as: hepatectomy alone
B, LR

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients \> 18 years and \<=70 years of age
  • Patients who have an ECOG PS of 0 or 1.
  • a preoperative diagnosis of HCC with no previous treatment;
  • compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
  • multiple tumors more than 5 cm or tumor involving a major branch of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasound and gross examination of the liver during the surgery;
  • on exploration and intraoperative ultrasound the tumor could safely be resected without grossly remaining tumors, and the patient was judged to have adequate liver functional reserve to survive the operation.

You may not qualify if:

  • Patient compliance is poor
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted.
  • History of cardiac disease:
  • congestive heart failure \> New York Heart Association (NYHA) class 2;
  • active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
  • cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
  • uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
  • Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • Distantly extrahepatic metastasis
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (7)

  • Edwards BK, Brown ML, Wingo PA, Howe HL, Ward E, Ries LA, Schrag D, Jamison PM, Jemal A, Wu XC, Friedman C, Harlan L, Warren J, Anderson RN, Pickle LW. Annual report to the nation on the status of cancer, 1975-2002, featuring population-based trends in cancer treatment. J Natl Cancer Inst. 2005 Oct 5;97(19):1407-27. doi: 10.1093/jnci/dji289.

    PMID: 16204691BACKGROUND

  • 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.

    PMID: 16696801BACKGROUND

  • Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology. 2004 Nov;127(5 Suppl 1):S35-50. doi: 10.1053/j.gastro.2004.09.014.

    PMID: 15508101BACKGROUND

  • Llovet JM, Bru C, Bruix J. Prognosis of hepatocellular carcinoma: the BCLC staging classification. Semin Liver Dis. 1999;19(3):329-38. doi: 10.1055/s-2007-1007122.

    PMID: 10518312BACKGROUND

  • 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: 16250051BACKGROUND

  • Ku Y, Iwasaki T, Tominaga M, Fukumoto T, Takahashi T, Kido M, Ogata S, Takahashi M, Kuroda Y, Matsumoto S, Obara H. Reductive surgery plus percutaneous isolated hepatic perfusion for multiple advanced hepatocellular carcinoma. Ann Surg. 2004 Jan;239(1):53-60. doi: 10.1097/01.sla.0000103133.03688.3d.

    PMID: 14685100BACKGROUND

  • Fan J, Zhou J, Wu ZQ, Qiu SJ, Wang XY, Shi YH, Tang ZY. Efficacy of different treatment strategies for hepatocellular carcinoma with portal vein tumor thrombosis. World J Gastroenterol. 2005 Feb 28;11(8):1215-9. doi: 10.3748/wjg.v11.i8.1215.

    PMID: 15754408BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • GUO Rong-ping, MD

    Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 3, 2008

Study Start

January 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 3, 2008

Record last verified: 2008-03

Locations

CN(1)