NCT00720668

Brief Summary

This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

2.8 years

First QC Date

July 21, 2008

Last Update Submit

February 6, 2009

Conditions

Hepatitis BHepatocellular Carcinoma

Keywords

hepatitis Bhepatocellular carcinomaradiofrequency ablationreactivation

Outcome Measures

Primary Outcomes (1)

  • The Rate of Exacerbation of chronic hepatitis B after RFA

    one week, one month, one year

Secondary Outcomes (2)

  • survival

    1, 3, 5-year

  • mortality

    one month

Study Arms (1)

1

patient with hepatocellular carcinoma after radiofrequency ablation

Procedure: radiofrequency ablation

Interventions

radiofrequency ablationPROCEDURE

radiofrequency ablation for HCC

Also known as: RFA
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with hepatocellular carcinoma (HCC) after percutaneous radiofrequency ablation.

You may qualify if:

  • Age 18 - 75 years
  • HBV carrier with HCC
  • After percutaneous radiofrequency ablation;
  • No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
  • No HCV or HIV co-infection
  • No previous treatment of HCC
  • No previous treatment of HBV except Lamivudine

You may not qualify if:

  • Patient compliance is poor
  • 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
  • Excluded therapies and medications, previous and concomitant
  • Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization
  • Prior use of systemic investigational agents for HCC
  • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (3)

  • 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: 16250051RESULT

  • Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.

    PMID: 11923602RESULT

  • Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

    PMID: 16495695RESULT

MeSH Terms

Conditions

Hepatitis BCarcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • min-shan chen, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

min-shan chen, MD

CONTACT

86-20-87343117Chminsh@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

May 1, 2010

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

CN(1)