Clinical trial NCT02169765: HR Versus RFA for Early Stage HCC
Official title: Hepatic Resection Versus Radiofrequency Ablation for Early-stage Hepatocellular Carcinoma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Liver Cancer
Keywords: Hepatocellular Carcinoma
Liver Cancer
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survivals
timeFrame: 5-years
Secondary outcomes:
measure: Recurrence rates
timeFrame: 5-years
Other outcomes:
measure: morbidity
timeFrame: 30,90 days
Locations:
city: Nanning
country: China
facility: Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
state: Guangxi
Study officials:
References:
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.
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.
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.
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.
citation: 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.