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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02435953
• Other study ID #: 2014-FXY-086
• Status: Recruiting
• Phase: Phase 4
• First received: May 3, 2015
• Last updated: October 12, 2016
• Start date: April 2015

Study information

• Verified date: October 2016
• Source: Sun Yat-sen University
• Contact: Ming Zhao, doctor
• Phone: +86 020 87343272
• Email: zhaoming[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China:Clinical Trials Centre,Sun Yat-sen University Cancer CenterChina: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• TACE
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.
• RFA
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.

Locations

Country	Name	City	State
China	Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Ming Zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		3 years	No
Secondary	Tumor progression rate		2 years	No
Secondary	Tumor progress to advanced-stage rate		2 years	No
Secondary	Hepatic dysfunction rate		2 years	No
Secondary	Adverse event rate		3 years	Yes