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RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

NCT04032860 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-05-25

No results posted yet for this study

Summary

In Asia, hepatocellular carcinoma (HCC) commonly occurred in the underlying hepatitis B virus (HBV)-related liver disease.Curative therapies could improve the prognosis of HCC patients. However, tumor recurrence after curative therapy remains high with a 5-year recurrence rate \>70%.The risk for HCC development is increased for patient with HBV infection，but there was no consensus about which kind of oral antiviral treatment was the best option in the prevention of HBV related HCC recurrence after curative treatment.Therefore, we conducted this study to investigate the different effects of nucleotides(TDF) and nucleosides(ETV) on the prognosis of HBV-related HCC after curative resection.

Conditions

  • HCC
  • HBV Coinfection

Interventions

DRUG

Tenofovir Disoproxil

patients with HBV-HCC would take TDF as antiviral therapy before curative treatment to see the prognosis after surgery

DRUG

Entecavir

patients with HBV-HCC would take ETV as antiviral therapy before curative treatment to see the prognosis after surgery

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • He Linye, Doctor · Westchina Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2022-07-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04032860 on ClinicalTrials.gov