HR Versus RFA for Early Stage HCC (ARTC-HCC)

Guangxi Medical University

Status and phase: Unknown; Phase 3

Conditions: Hepatocellular Carcinoma; Liver Cancer

Treatments: Other: Radiofrequency ablation; Other: Hepatic resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02169765

HRRFA-HCC (Registry Identifier)

Details and patient eligibility

About

Hepatocellular carcinoma (HCC) is the third leading death cancer in the world. It is important to explore a safe and effective therapy for early-stage HCC. Previous studies reported that radiofrequency ablation (RFA) has higher efficacy and is associated with fewer complications and shorter hospital stays than hepatic resection (HR) for early-stage HCC. However, meta-analysis and systematic review found that RFA is associated with higher recurrence rate and lower long-term overall survival.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 years
• Clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
• Tumor stage fitted into Milan Criteria
• Patients have Child-Pugh A liver function
• No previous neoadjuvant treatment
• No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
• No malignancy other than HCC for 5 years prior to the initial HCC treatment
• No history of encephalopathy, ascites refractory to diuretics or variceal bleeding

Exclusion criteria

• 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 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

• 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:

  • 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: None (Open label)

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120 participants in 2 patient groups

Hepatic resection

Active Comparator group

Description:

Indications for HR were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.

Treatment:

Other: Hepatic resection

Radiofrequency ablation

Experimental group

Description:

Radiofrequency ablation is performed in less than one week after clinical diagnosis.

Treatment:

Other: Radiofrequency ablation