Hepatocellular Carcinoma, Liver Cancer
Conditions
Keywords
Hepatocellular Carcinoma, Liver Cancer
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.
Interventions
OTHERHepatic 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.
OTHERRadiofrequency ablation
Radiofrequency ablation is performed in less than one week after clinical diagnosis.
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivals | 5-years |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rates | 5-years |
Other
| Measure | Time frame |
|---|---|
| morbidity | 30,90 days |
Countries
China
Contacts
Primary ContactJian-Hong Zhong, MD
Outcome results
None listed