Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Overall survivals
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.
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 ≤ 5.0 cm, 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 5 cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5 cm. 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) has proven to be an effective and palliative therapy for unresectable HCC. And some prospective randomized controlled trials have shown that adjuvant TACE after curative resection for HCC can improve the overall survivals and decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant therapy after RFA for HCC. Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant therapy after RFA for HCC will improve the outcomes of RFA.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 - 75 years, and refused surgery
- •A solitary HCC ≤ 7.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0 cm 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 so that TACE cannot 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 and 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
- •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 survivals
Time Frame: 3, and 5-years
Secondary Outcomes
- Recurrence rates(3, and 5-years)