HR Versus RFA for Early Stage HCC

Hepatocellular Carcinoma Clinical Trial

— ARTC-HCC  

Official title:

Hepatic Resection Versus Radiofrequency Ablation for Early-stage Hepatocellular Carcinoma: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02169765
• Other study ID #: HRRFA-HCC
• Secondary ID: HRRFA-HCC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2020
• Source: Guangxi Medical University
• Contact: Jian-Hong Zhong, MD
• Phone: 86-771-5330855
• Email: zhongjianhong66[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

Intervention

Other:
• Hepatic resection
Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.
• Radiofrequency ablation
Radiofrequency ablation is performed in less than one week after clinical diagnosis.

Locations

Country	Name	City	State
China	Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Cho YK, Kim JK, Kim WT, Chung JW. Hepatic resection versus radiofrequency ablation for very early stage hepatocellular carcinoma: a Markov model analysis. Hepatology. 2010 Apr;51(4):1284-90. doi: 10.1002/hep.23466. — View Citation

Cho YK, Rhim H, Noh S. Radiofrequency ablation versus surgical resection as primary treatment of hepatocellular carcinoma meeting the Milan criteria: a systematic review. J Gastroenterol Hepatol. 2011 Sep;26(9):1354-60. doi: 10.1111/j.1440-1746.2011.06812.x. Review. — View Citation

Cucchetti A, Piscaglia F, Cescon M, Colecchia A, Ercolani G, Bolondi L, Pinna AD. Cost-effectiveness of hepatic resection versus percutaneous radiofrequency ablation for early hepatocellular carcinoma. J Hepatol. 2013 Aug;59(2):300-7. doi: 10.1016/j.jhep.2013.04.009. Epub 2013 Apr 18. — View Citation

Duan C, Liu M, Zhang Z, Ma K, Bie P. Radiofrequency ablation versus hepatic resection for the treatment of early-stage hepatocellular carcinoma meeting Milan criteria: a systematic review and meta-analysis. World J Surg Oncol. 2013 Aug 13;11(1):190. doi: 10.1186/1477-7819-11-190. Review. — View Citation

Wang Y, Luo Q, Li Y, Deng S, Wei S, Li X. Radiofrequency ablation versus hepatic resection for small hepatocellular carcinomas: a meta-analysis of randomized and nonrandomized controlled trials. PLoS One. 2014 Jan 3;9(1):e84484. doi: 10.1371/journal.pone.0084484. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	morbidity		30,90 days
Primary	Overall survivals		5-years
Secondary	Recurrence rates		5-years