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

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Hepatic resection; Procedure: TACE; Procedure: RFA

• Registration Number: NCT02616926
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-10-25
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-30
• Status Verified: 2015-12
• Study Start: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07
• Primary Completion: 2018-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

1. Hepatocellular Carcinoma diagnosed by biopsy or imaging criteria (CT/MRI) and AFP
2. Signed informed consent before registration on study
3. Child-Pugh class A or B
4. Eastern Cooperative Oncology Group Performance status between 0 and 2.
5. BCLC stage B ( diameter of the single tumor ≥5cm or number of tumors ≥3)
6. Hepatitis B history or HBsAg positive
7. Age between 18 and 65 years
8. No previous treatment
9. 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
10. 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

1. cachexia or poor physical condition;
2. pregnant or HCG positive;
3. Portal vein and bile duct thrombosis or with extra hepatic metastasis.
4. Uncontrolled or refractory ascites or history of hepatic encephalopathy
5. Severe heart, brain or kidney diseases
6. hemophilia or patients with coumarin derivative therapy.
7. .history of organ transplantation or mental disease.
8. Be allergic to adriamycin, lobaplatin, mitomycin or iodized oil

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE + RFA	RFA	TACE is performed as a primary treatment for hepatocellular carcinoma. RFA will be performed two weeks later if necessary. Intervention: TACE; RFA
Hepatic resection	Hepatic resection	Hepatic resection is performed as a primary treatment for hepatocellular carcinoma. Intervention: Hepatic resection
TACE + RFA	TACE	TACE is performed as a primary treatment for hepatocellular carcinoma. RFA will be performed two weeks later if necessary. Intervention: TACE; RFA

Primary Outcome Measures

Name	Time	Method
overall survival	3 years	compare 3-year overall survival between the two arms

Secondary Outcome Measures

Name	Time	Method
disease free survival	3 years	compare 3-year disease free survival between the two arms

Trial Locations

Locations (3)

Department of Hepatobiliary Surgery, Sun-Yat Sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China

Department of Hepatic Surgery, First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Department of Hepatobiliary Surgery, Cancer Center of Sun-Yat Sen University; 🇨🇳 Guangzhou, Guangdong, China