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

NCT00455091 | Terminated DMC

• 1 other identifier: T1206
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 8

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 flare up (HBV DNA \> 105 copies/mL and ALT level \> 2.0 x UNL) or prophylactic, prolong (36 months) adefovir dipivoxil therapy in post-operative HBsAg(+),\< 5 cm HCC patients, and to compare the results of who group with historical controls (T1297, HBsAg+,\< 5 cm HCC cohort),in terms of the following endpoints.

1. 1.Primary endpoint:
2. 2.Secondary endpoints:

Conditions

Hepatocellular Carcinoma

Keywords

Post-operative Hepatocellular Carcinoma.

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: Primary endpoint: the 3-years recurrence rate (excluding those recur within first year).

  6 years

Secondary Outcomes (1)

• Secondary endpoints: the first 2 year tumor recurrence rates,the recurrence-free survival,the overall survival.anti-viral efficacy.

  7 years

Interventions

Adefovir Dipivoxil and Lamivudine DRUG

Adefovir Dipivoxil 10mg/day x 36 months,Lamivudine 100 mg/day x 18 months#, when HBV DNA =/\> 105 copies/mL and ALT \> 2.0 x UNL

Also known as: Hepsera,Zeffix

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Post-operative HBV-related Hepatocellular Carcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Mackay Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• Changhua Christian Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Veterans General Hospital.: collaborator
• Kaohsiung Medical University: collaborator

Study Sites (8)

Chang-Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Veterans General Hospital-Kaohsiung

Kaohsiung City, Taiwan

Location

Chang-Gung Memorial Hospital (Lin-Kou)

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Veterans General Hospital-Taipei

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

HBVDNA

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

adefovir dipivoxil; Lamivudine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Li-Tzong Chen, Ph.D.

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

• Pei-Jer Chen, Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Miin-Fu Chen, M.D.

  Chang Gung Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 3, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2018
• Last Updated: April 28, 2017

Record last verified: 2009-06

Locations

TW (8)