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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Hepatocellular Carcinoma; Liver Cancer

Treatments: Procedure: RFA; Drug: lamivudine or entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT00555334

RFA-002

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

1

Experimental group

Description:

nucleoid antiviral therapy after RFA

Treatment:

Drug: lamivudine or entecavir

Procedure: RFA

2

Active Comparator group

Description:

RFA only

Treatment:

Procedure: RFA