Efficacy and Significance of Antiviral Therapy for Unrese... | NCT00824707

Studies
Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer

NCT00824707

Sponsor

Eastern Hepatobiliary Surgery Hospital

Status

Completed

Last Update Posted

Apr 1, 2016Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Primary Liver Cancer

Interventions

Entecavir
conventional therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2016

Last Update Posted Date

Apr 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

primary liver cancer(PLC)is one of the world's most common malignancies, especially in East-Asian countries.Hepatitis B virus (HBV) infection is associated with 70-90% of PLC cases in China. PLC can develop during any stage of the natural course of chronic HBV infection and anti-virus therapy should be considered during the management of PLC. However, there is no definite guide on when or how to practice the anti-virus therapy, especially in unresectable or inoperable PLC. Because of these facts, research on the significant of the anti-virus therapy in the HBV-related PLC is urgently needed.

200 patients will be randomly assigned to anti-virus therapy group and control gruop.The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of anti-virus therapy on PLC.

The aim of this study is to research the efficacy and significant of the anti-virus therapy in the unresectable HBV-related PLC so as to establish treatment standards of anti-virus therapy in PLC.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Entecavir	Drug	Entecavir 0.5mg per day	anti-virus therapy	anti-virus group

Measure	Description	Time Frame
time-to-progression(TTP)		1,2 and 3 years

Measure	Description	Time Frame
Overall survival (OS)		1,2 and 3 years
The overall response rate		1,2 and 3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Shen Feng, M.D	Eastern Hepatobiliary Surgery Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Eastern Hepatobiliary Surgery Hospital		Shanghai	Shanghai Municipality	200438	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C413685	entecavir
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided