Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— RFA and TACE  

Official title:

Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00554905
• Other study ID #: rfa-001
• Status: Recruiting
• Phase: Phase 4
• First received: November 6, 2007
• Last updated: February 6, 2009
• Start date: October 2006
• Est. completion date: June 2009

Study information

• Verified date: February 2009
• Source: Sun Yat-sen University
• Contact: Min-Shan Chen, Doctor
• Phone: 86-20-87343117
• Email: Chminsh[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

• Known central nervous system tumors including metastatic brain disease

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

• Distantly extrahepatic metastasis

• 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:

• Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.

• Prior use of systemic investigational agents for HCC

• Autologous bone marrow transplant or stem cell rescue within four months of start of study drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Radiofrequency ablation
For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, California, USA) and a needle electrode with a 15-gauge insulated cannula with 10 hook-shape expandable electrode tines with a diameter of 3.5cm at expansion (LeVeen; RadioTherapeutics, Mountain View, California, USA).
• TACE
TACE first, then RFA within 2 weeks

Locations

Country	Name	City	State
China	Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		3, 5 years	No
Secondary	Recurrence rates		3, 5-years	No