Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to prospectively evaluate whether combined RFA and TACE (RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.
Detailed Description
Local ablation is a safe and effective therapy for patients who cannot undergo resection, or as a bridge to transplantation. Of the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for small HCC ≤ 5.0cm, with a 3-year survival rate of 62% to 68%, a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%. Prospective randomized trials have shown RFA to be better than percutaneous ethanol injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of treatment sessions and better survival. Unfortunately, the complete tumor necrosis rate for tumors larger than 5cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA or adjacent microscopic satellite tumor nodules. Transcatheter Arterial Chemoembolization (TACE) is proved to be an effective and palliative therapy for unresectable HCC. And some studies showed that combined TACE and RFA may produce superior tumor control than RFA alone and reduce local recurrence rate. In a study by Yamakado et al., 64 patients with 92 tumors underwent RFA within two weeks after TACE. The intrahepatic recurrence rates were 15% at 1 year and 43% at 2years, the 1, and 2, year overall survivals were 100% and 93%, respectively. These results appeared favorable, but there has not a prospective randomized controlled study to compare RFA combine with TACE versus RFA alone. Thus the purpose of our study was to prospectively evaluate whether combined RFA and TACE (RFA-TACE) result in better survival outcomes than RFA alone in patients with HCC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 - 75 years, who refused surgery
- •A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
- •Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
- •No extrahepatic metastasis
- •No imaging evidence of invasion into the major portal/hepatic vein branches
- •No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
- •A platelet count of \> 40,000/mm3
- •No previous treatment of HCC except liver resection
Exclusion Criteria
- •Patient compliance is poor
- •The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
- •Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted.
- •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 \[CTCAE\] version 3.0)
- •Known history of human immunodeficiency virus (HIV) infection
Outcomes
Primary Outcomes
Overall Survival
Time Frame: 3, 5 years
Secondary Outcomes
- Recurrence rates(3, 5-years)