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Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma

NCT01872988 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2014-09-04

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide, and chronic hepatitis B virus (HBV) infection is the most common etiology of HCC in Asia. Transarterial chemoembolization (TACE) is the standard treatment for patients with unresectable HCC in the BCLC intermediate stage, but the HCC recurrence rates and long-term mortality rates are quite high. These intermediate-staged HCC patients usually need repeated TACE due to tumor recurrence, and they may die of HCC progression or liver decompensation after repeated TACE. Improved liver function and decreased liver disease progression due to oral antiviral therapy have been proven to be effective for chronic hepatitis B, and oral antiviral therapy may keep better liver reserve and provide better chance for HCC patients received TACE. In addition, chronic HBV infection is one of the most important factors for HCC development, and antiviral therapy can improve the outcomes after curative treatment. However, the evidence of improving outcomes of HCC patients underwent TACE by oral antiviral therapy is lacking. Moreover, Tenofovir Disoproxil Fumarate (TDF) is one of the most potent oral antiviral agents, and its safety and very low long-term viral resistance rate have been also reported. There is no study to evaluate the impacts of TDF for HBV-related HCC patients underwent TACE. Until now, routine antiviral therapy for HBV-related HCC patients underwent TACE has still not been recommended by current guidelines. The hypothesis of this study is that a potent oral antiviral therapy for patients with HBV-related HCC patients receiving TACE improve patients' outcomes

Conditions

Interventions

DRUG

Tenofovir

Administer Tenofovir to HCC patients who are indicated for TACE after randomization

DRUG

Placebo

Administer Placebo to HCC patients who are indicated for TACE after randomization

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Taipei Institute of Pathology

    collaborator OTHER_GOV

  • Taichung Veterans General Hospital

    lead OTHER

Principal Investigators

  • Chun-Ying Wu, MD, PhD, MPH · Taichung Veterans General Hospital

  • Jaw-Town Lin, MD, PhD · Fu Jen Catholic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01872988 on ClinicalTrials.gov