TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial

Hepatocellular Carcinoma Clinical Trial

— TACE+RFA  

Official title:

Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636620
• Other study ID #: LC-TACE+RFA/MV
• Status: Completed
• Phase: Phase 3
• Start date: June 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.

Description:

The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients diganosed with hepatocellualr carcinoma beyond Milan criteria

• the presence of a single HCC tumor =7 cm in diameter, or multi-nodular HCC tumors (n = 5) small than 7 cm in diameter;

• Child-Pugh A or B

• ECOG score 0-1;

• prothrombin time =16 s;

• white cell count =3,000/mm3, platelet count =40 x 109/L;Hb=8.5 g/d; ALT/AST=5×ULN;TB=3mg/dl;alb=2.8 g/dl ;Scr =2mg/dl

Exclusion Criteria:

• expected survival time < 12 months before random assignment;

• received anticancer surgery or procedure within one month before assignment;

• concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;

• existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;

• upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• Transcatheter arterial chemoembolization
Transcatheter arterial chemoembolization
• radiofrequency ablation/microwave ablation
radiofrequency ablation/microwave ablation

Locations

Country	Name	City	State
China	liver cancer institute ,Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		up to 46 months
Secondary	objective response rate		up to 46 months