Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

NCT00555334 | Unknown Phase 4 DMC

• 1 other identifier: RFA-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the investigators' study is to prospectively evaluate whether nucleoid antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma; Liver Cancer

Keywords

hepatocellular carcinoma; liver cancer; radiofrequency ablation; lamivudine

Outcome Measures

Primary Outcomes (1)

• Overall survivals

  3, 5-years

Secondary Outcomes (1)

• Recurrence rates

  3, 5-years

Study Arms (2)

1

EXPERIMENTAL

nucleoid antiviral therapy after RFA

Procedure: RFA; Drug: lamivudine or entecavir

2

ACTIVE COMPARATOR

RFA only

Procedure: RFA

Interventions

RFA PROCEDURE

radiofrequency ablation

1; 2

lamivudine or entecavir DRUG

lamivudine (100mg qd) or entecavir (0.5mg qd) after RFA

Also known as: LAM-RFA

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 75 years, who refused surgery;
• A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
• Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US,
• No extrahepatic metastasis
• No imaging evidence of invasion into the major portal/hepatic vein branches
• No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
• A platelet count of \> 40,000/mm3
• No previous treatment of HCC except liver resection.

You may not qualify if:

• Patient compliance is poor
• The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted.
• History of cardiac disease:
• congestive heart failure \> New York Heart Association (NYHA) class 2;
• active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
• cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
• uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
• Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Distantly extrahepatic metastasis
• History of organ allograft
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

• Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.

  PMID: 16250051 BACKGROUND

• Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.

  PMID: 11923602 BACKGROUND

• Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

  PMID: 16495695 BACKGROUND

• Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.

  PMID: 11419162 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Lamivudine; entecavir

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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

• min-shan chen, doctor

  Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Shan Chen, Docter

CONTACT

86-20-87343117; Chminsh@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 8, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 1, 2009

Record last verified: 2009-03

Locations

CN (1)