Hepatic Resection Versus TACE+RFA for BCLC Stage B Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world. For patients with intermediate HCC (BCLC stage B), transarterial chemoembolization (TACE) has been recommended as the standard therapy in many clinical practice guidelines. The combination of TACE and radiofrequency ablation (RFA) has also been reported as an effective treatment. However, more and more retrospective studies have reported better therapeutic efficacy of hepatic resection than TACE for intermediate HCC. The purpose of this study was to compare the efficacy of hepatic resection versus TACE+RFA for the treatment of intermediate HCC through prospective randomized clinical trial.

Detailed Description
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Barcelona Clinic Liver Cancer (BCLC) staging system is the most widely used stage classification for HCC management. For patients with intermediate HCC, palliative treatment transarterial chemoembolization (TACE) was recommended as first choice treatment. However, this recommendation remains controversial. The advice for diagnosis and treatment of HCC from former Chinese Ministry of Health indicated that BCLC may not be suitable in China as most HCC patients were found in intermediate or advanced stage. In recent years, more and more studies declared surgical resection as a better choice for HCC patients in BCLC stage B. However, lack of randomization, small sample size and lack of prospective studies limit the strength of evidence. To solve this dilemma, a prospective randomized control study was performed to compare the efficacy (1-, 2-, 3-year survival) between surgical resection group and TACE plus radiofrequency ablation group in HCC patients in intermediate stage. This study will provide powerful evidence regarding the better treatment option for HCC patients in BCLC B stage, which will benefit the treatment efficacy of HCC patients in BCLC B stage.

Official Title
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Hepatic Resection Versus Transarterial Chemoembolization Plus Radiofrequency Ablation for Barcelona Clinic Liver Cancer Stage B Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Hepatic resection
* Procedure: TACE
* Procedure: RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular Carcinoma diagnosed by biopsy or imaging criteria (CT/MRI) and AFP Signed informed consent before registration on study Child-Pugh class A or B Eastern Cooperative Oncology Group Performance status between 0 and 2. BCLC stage B ( diameter of the single tumor ≥5cm or number of tumors ≥3) Hepatitis B history or HBsAg positive Age between 18 and 65 years No previous treatment Laboratory examination test: Platelet count ≥100×109/L; ALT/AST ≤ 3 x ULN; Cr1.5≤ x ULN; INR < 1.5 or PT< ULN +4s; Alb≥30g/L; Tbil≤34mmol/L For patients in Hepatic resection group: radical surgery will be performed: (1) No segmental, lobar or main portal vein and bile duct thrombosis; (2) no lymph nodes metastasis; (3) no extra hepatic metastasis. Exclusion Criteria: cachexia or poor physical condition; pregnant or HCG positive; Portal vein and bile duct thrombosis or with extra hepatic metastasis. Uncontrolled or refractory ascites or history of hepatic encephalopathy Severe heart, brain or kidney diseases hemophilia or patients with coumarin derivative therapy. .history of organ transplantation or mental disease. Be allergic to adriamycin, lobaplatin, mitomycin or iodized oil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatic resection<br>Hepatic resection is performed as a primary treatment for hepatocellular carcinoma. Intervention: Hepatic resection | Procedure: Hepatic resection<br>* Anatomical surgical resection of the liver including the tumor. Make sure the resection margin is negative during the process.<br>* Other names: hepatectomy;|
| Active Comparator: TACE + RFA<br>TACE is performed as a primary treatment for hepatocellular carcinoma. RFA will be performed two weeks later if necessary. Intervention: TACE; RFA | Procedure: TACE<br>* TACE will be performed according to the standard procedure of TACE and will be repeated every four months if needed<br>* Other names: transcatheter arterial chemoembolization;Procedure: RFA<br>* RFA will be performed 1 week after TACE.<br>* Other names: radiofrequency ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | compare 3-year overall survival between the two arms | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | compare 3-year disease free survival between the two arms | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, hepatectomy, transarterial chemoembolization, radiofrequency ablation