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NCT Number: NCT00824707

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

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.

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Key information

Conditions

Primary Liver Cancer Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Entecavir

Drug

Entecavir 0.5mg per day

Other names: anti-virus group

Conventional therapy

Drug

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

Other names: control group

Primary outcomes

  1. time-to-progression(TTP)

    Time frame: 1,2 and 3 years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 1,2 and 3 years

  2. The overall response rate

    Time frame: 1,2 and 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 19, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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