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Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

Radiofrequency Ablation With or With Transcatheter Arterial Embolization for Hepatocellular Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Survival

Outcome Time Frame:

3, 5 years

Safety Issue:

No

Principal Investigator

Min-Shan Chen, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

rfa-001

NCT ID:

NCT00554905

Start Date:

October 2006

Completion Date:

June 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • ablation
  • catheter
  • Carcinoma, Hepatocellular
  • therapy
  • Chemoembolization, Therapeutic
  • Humans
  • Liver Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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