TACE+RFA Versus TACE Alone for Intermediate-stage Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The current standard treatment for intermediate-stage HCC (BCLC stage B) is transcatheter arterial chemoembolization (TACE) alone.The combination of TACE with RFA has also reported to be an effective treatment for HCC. Some prospective studies have shown TACE combined RFA to have better efficacy than any of them alone for early stage HCC (single tuomor ≤5 cm). However, to the investigators' knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than TACE alone for the treatment of intermediate-stage HCC. The investigators hypothesized that the combination of TACE and RFA might result in better patient survival than TACE alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with TACE alone for the treatment of intermediate-stage HCC. Intermediate-stage HCC in this study was defined as 2-3 intrahepatic lessions, largest tumor size 3-7 cm or 4-10 intrahepatic lessions, largest tumor size ≤7 cm; ECOG-PS 0;Child-pugh A or B;no tumor thrombus or extrahepatic metastases.

Official Title
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Transarterial Chemoembolization Plus Radiofrequency Ablation Versus Transarterial Chemoembolization Alone for Intermediate-stage Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma, Chemoembolization, Therapeutic, Ablation Techniques, RFA

Intervention / Treatment
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* Procedure: TACE
* Procedure: RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter No vascular invasion or etrahepatic metastases Eastern Cooperative Oncology Group Performance Status 0-1 Child-Pugh Stage A or B Treatment naive Exclusion Criteria: A platelet counts of <40×109/L，prothrombin time activity <40%; Albumin >2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit No evaluale target lesions Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy Severe heart, brain or kidney diseases Previous or concurrent cancer that is distinct in primary site or histology from HCC Pregnant women or lactating women Be allergic to adriamycin, lobaplatin, mitomycin and iodized oil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE-RFA<br>1-2 times of TACE treatment, then followed by RFA treatment. | Procedure: TACE<br>* TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.<br>Procedure: RFA<br>* For RFA, we used two commercially available system (Cool-Tip, Valleylab，USA) and (Octopus RF Systema，Starmed,Korea）with needle electrode with a 17-gauge internally cooled electrode.<br>|
| Active Comparator: TACE alone<br>TACE treatment several times till tumor progress to advance stage | Procedure: TACE<br>* TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor progression rate |  | 2 years | 
| Tumor progress to advanced-stage rate |  | 2 years | 
| Hepatic dysfunction rate |  | 2 years | 
| Adverse event rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma,TACE,Chemoembolization, RFA,Intermediate-stage