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

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Transcatheter arterial chemoembolization; Device: radiofrequency ablation/microwave ablation

• Registration Number: NCT03636620
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE group	Transcatheter arterial chemoembolization	Transcatheter arterial chemoembolization
TACE+RFA/MV group	radiofrequency ablation/microwave ablation	Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
TACE+RFA/MV group	Transcatheter arterial chemoembolization	Transcatheter arterial chemoembolization and radiofrequency /microwave ablation

Primary Outcome Measures

Name	Time	Method
overall survival	up to 46 months

Secondary Outcome Measures

Name	Time	Method
objective response rate	up to 46 months

Trial Locations

Locations (1)

liver cancer institute ,Fudan University; 🇨🇳 Shanghai, China