NCT02616926

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 538 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Hepatic resection	Anatomical surgical resection of the liver including the tumor. Make sure the resection margin is negative during the process.
PROCEDURE	TACE	TACE will be performed according to the standard procedure of TACE and will be repeated every four months if needed
PROCEDURE	RFA	RFA will be performed 1 week after TACE.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-07-01
• Completion: 2021-07-01
• First posted: 2015-11-30
• Last updated: 2015-12-07

Locations

3 sites across 1 country: China