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Status:

TERMINATED

A Phase III Study in Post-operative HBV-related Hepatocellular Carcinoma

Lead Sponsor:

National Health Research Institutes, Taiwan

Collaborating Sponsors:

National Taiwan University Hospital

Chang Gung Memorial Hospital

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18-70 years

Brief Summary

Research Objective and Study End Points To evaluate the anti-HBV as well as HCC recurrence reducing effects of standard (18 months) lamivudine treatment at time of HBV reactivation with hepatitis flar...

Detailed Description

Treatment plan and Randomization scheme: HBsAg+, HCC\< 5 cm with curative resection Stratified with HBV DNA \< 105 OR ≥ 105 copies/mL Genotype B or C RANDOMIZATION Prophylactic group Therapeutic cont...

Eligibility Criteria

Inclusion

  • Histologically proven hepatocellular carcinoma.
  • HCC underwent curative resection within 6 weeks before registration.
  • Grossly, the resection margin should be \> 1 cm.
  • Tumors, either single, \< 5 cm in size or no more than 3 for size \< 3 cm.
  • Patients must have a performance status of ECOG score \< 2.
  • Patients must have adequate liver reservation and adequate hemogram.
  • Pugh-Child's Score \< 7.
  • The serum total bilirubin level are \< 2 mg/dl.
  • The prothrombin times are \< 3 sec above normal control.
  • The platelet are \> 7.5 x 104 / mm3.
  • The WBC are \> 3,000 / mm3.
  • Patient must have serum creatinine \< 1.5 mg/dl
  • Cardiac function with NYHA classification \< Grade II
  • HBsAg (+) .
  • Signed informed consent.

Exclusion

  • Patients who have non-curative resection are not eligible.
  • Resected HCCs with histologically positive margins are not eligible.
  • HCCs with radiological evidence of portal vein thrombus are not eligible.
  • Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
  • Patients with advanced second primary malignancy are not eligible.
  • Patients with pregnancy or breast-feeding are not eligible.
  • Patients with severe cardiopulmonary diseases are not eligible.
  • Patients with clinically significant psychiatric disorder are not eligible.
  • Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
  • Patients who had prior lamividine and/or adefovir dipivoxil therapy are not eligible.
  • Anti-HCV positive patients are not eligible.

Key Trial Info

Start Date :

May 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2018

Estimated Enrollment :

117 Patients enrolled

Trial Details

Trial ID

NCT00455091

Start Date

May 1 2007

End Date

April 1 2018

Last Update

April 28 2017

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Chang-Gung Memorial Hospital

Kaohsiung City, Taiwan

2

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

3

Veterans General Hospital-Kaohsiung

Kaohsiung City, Taiwan

4

Chang-Gung Memorial Hospital (Lin-Kou)

Taichung, Taiwan