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

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ClinicalTrials.gov Identifier: NCT00824707
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

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.

Condition or disease Intervention/treatment Phase
Primary Liver Cancer Drug: Entecavir Drug: conventional therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study to Evaluate the Efficacy and Significant of the Anti-virus Therapy for the Unresectable Hepatitis B Virus-related Primary Liver Cancer
Study Start Date : December 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Experimental: anti-virus therapy
100 HCC patients will be allocated to receive anti-virus therapy.
Drug: Entecavir
Entecavir 0.5mg per day
Other Name: anti-virus group

Active Comparator: conventional therapy
100 patients will undergo conventional therapy
Drug: conventional therapy
conventional therapy including protecting the liver function, anti-tumor and so on
Other Name: control group




Primary Outcome Measures :
  1. time-to-progression(TTP) [ Time Frame: 1,2 and 3 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 1,2 and 3 years ]
  2. The overall response rate [ Time Frame: 1,2 and 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. serum positive HBsAg≥6 months.
  3. 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.
  4. hemoglobin≥8.5g/dl, PT-INR≤2.3 or PT>6 seconds of normal value.
  5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  6. Patients who can understand this trial, male or female, aged 18-70 voluntarily participate in clinical trials and have signed information consent.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824707


Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Shen Feng, M.D Eastern Hepatobiliary Surgery Hospital

Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00824707     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-005
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
primary liver cancer
hepatitis B virus
anti-virus therapy

Additional relevant MeSH terms:
Liver Neoplasms
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Entecavir
Antiviral Agents
Anti-Infective Agents