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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00555334
First received: November 7, 2007
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

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).


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Procedure: RFA
Drug: lamivudine or entecavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Overall survivals [ Time Frame: 3, 5-years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence rates [ Time Frame: 3, 5-years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
nucleoid antiviral therapy after RFA
Procedure: RFA
radiofrequency ablation
Other Name: RFA
Drug: lamivudine or entecavir
lamivudine (100mg qd) or entecavir (0.5mg qd) after RFA
Other Name: LAM-RFA
Active Comparator: 2
RFA only
Procedure: RFA
radiofrequency ablation
Other Name: RFA

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555334

Contacts
Contact: Min-Shan Chen, Docter 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: min-shan chen, doctor    86-20-87343117 ext 86-20-87343117    Chminsh@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: min-shan chen, doctor Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
  More Information

Publications:
Responsible Party: CancerCcanter, Sun Yat-sen University, Cancer Canter, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00555334     History of Changes
Other Study ID Numbers: RFA-002
Study First Received: November 7, 2007
Last Updated: March 31, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
liver cancer
radiofrequency ablation
lamivudine

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Lamivudine
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 20, 2014