NCT00824707

Brief Summary

This study is working to research the efficacy and significant of the anti-virus therapy in the unresectable Hepatitis B virus (HBV) related primary liver cancer(PLC) so as to establish treatment standards of anti-virus therapy in PLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

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

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

January 16, 2009

Last Update Submit

March 30, 2016

Conditions

Primary Liver Cancer

Keywords

primary liver cancerhepatitis B virusanti-virus therapy

Outcome Measures

Primary Outcomes (1)

  • time-to-progression(TTP)

    1,2 and 3 years

Secondary Outcomes (2)

  • Overall survival (OS)

    1,2 and 3 years

  • The overall response rate

    1,2 and 3 years

Study Arms (2)

anti-virus therapy

EXPERIMENTAL

100 HCC patients will be allocated to receive anti-virus therapy.

Drug: Entecavir

conventional therapy

ACTIVE COMPARATOR

100 patients will undergo conventional therapy

Drug: conventional therapy

Interventions

EntecavirDRUG

Entecavir 0.5mg per day

Also known as: anti-virus group
anti-virus therapy
conventional therapyDRUG

conventional therapy including protecting the liver function, anti-tumor and so on

Also known as: control group
conventional therapy

Eligibility Criteria

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

You may qualify if:

  • Identify patients with PLC in accordance with the clinical diagnostic criteria of PLC.Patients with PLC shall be diagnosed with or without pathology. It is not appropriate to perform liver resection operation.
  • serum positive HBsAg≥6 months.
  • Criteria of liver function: Child A or B level, serum total bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 10 times the upper limit of normal value.
  • hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT\>6 seconds of normal value.
  • No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  • Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.

You may not qualify if:

  • Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction, which may affect the treatment of liver cancer.
  • Patients with other diseases which may affect the treatment mentioned here.
  • Patients with medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • Women in pregnancy and breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis B

Interventions

entecavirControl Groups

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Shen Feng, M.D

    Eastern Hepatobiliary Surgery Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

December 1, 2008

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

CN(1)