Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma (LAM-RFA)

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).

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Liver Cancer
• Intervention / Treatment: Procedure: RFA; Drug: lamivudine or entecavir

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
      • Contact: min-shan chen, doctor; Phone Number: 86-20-87343117 86-20-87343117; Email: Chminsh@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion Criteria:
• 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.

Exclusion Criteria:

• 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
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.

• Excluded therapies and medications, previous and concomitant:

  • Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
  • Prior use of systemic investigational agents for HCC
  • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; nucleoid antiviral therapy after RFA	Procedure: RFA; radiofrequency ablation; Drug: lamivudine or entecavir; lamivudine (100mg qd) or entecavir (0.5mg qd) after RFA; Other Names: LAM-RFA
Active Comparator: 2; RFA only	Procedure: RFA; radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survivals	3, 5-years

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence rates	3, 5-years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: min-shan chen, doctor, Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: November 7, 2007
• First Submitted That Met QC Criteria: November 7, 2007
• First Posted (Estimate): November 8, 2007

Study Record Updates

• Last Update Posted (Estimate): April 1, 2009
• Last Update Submitted That Met QC Criteria: March 31, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: radiofrequency ablation; hepatocellular carcinoma; lamivudine; liver cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Entecavir; Lamivudine
• Other Study ID Numbers: RFA-002