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

Phase 4

• Conditions: Hepatocellular Carcinoma; Chemoembolization, Therapeutic; Ablation Techniques, RFA
• Interventions: Procedure: TACE; Procedure: RFA

• Registration Number: NCT02435953
• Lead Sponsor: Ming Zhao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-05-03
• Study First Posted: 2015-05-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13
• Primary Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE-RFA	TACE	1-2 times of TACE treatment, then followed by RFA treatment.
TACE alone	TACE	TACE treatment several times till tumor progress to advance stage
TACE-RFA	RFA	1-2 times of TACE treatment, then followed by RFA treatment.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	3 years

Secondary Outcome Measures

Name	Time	Method
Tumor progression rate	2 years
Tumor progress to advanced-stage rate	2 years
Hepatic dysfunction rate	2 years
Adverse event rate	3 years

Trial Locations

Locations (1)

Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,; 🇨🇳 Guangzhou, Guangdong, China