HR Versus RFA for Early Stage HCC

Phase 3

• Conditions: Liver Cancer; Hepatocellular Carcinoma
• Interventions: Other: Radiofrequency ablation; Other: Hepatic resection

• Registration Number: NCT02169765
• Lead Sponsor: Guangxi Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22
• Study Start: 2020-08-01
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablation	Radiofrequency ablation	Radiofrequency ablation is performed in less than one week after clinical diagnosis.
Hepatic resection	Hepatic resection	Indications for HR were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.

Primary Outcome Measures

Name	Time	Method
Overall survivals	5-years

Secondary Outcome Measures

Name	Time	Method
Recurrence rates	5-years

Trial Locations

Locations (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University; 🇨🇳 Nanning, Guangxi, China