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

NCT ID: NCT03636620

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

TACE vs.TACE+RFA
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TACE group

Transcatheter arterial chemoembolization

Group Type ACTIVE_COMPARATOR

Transcatheter arterial chemoembolization

Intervention Type DEVICE

Transcatheter arterial chemoembolization

TACE+RFA/MV group

Transcatheter arterial chemoembolization and radiofrequency /microwave ablation

Group Type EXPERIMENTAL

Transcatheter arterial chemoembolization

Intervention Type DEVICE

Transcatheter arterial chemoembolization

radiofrequency ablation/microwave ablation

Intervention Type DEVICE

radiofrequency ablation/microwave ablation

Interventions

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Transcatheter arterial chemoembolization

Transcatheter arterial chemoembolization

Intervention Type DEVICE

radiofrequency ablation/microwave ablation

radiofrequency ablation/microwave ablation

Intervention Type DEVICE

Other Intervention Names

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TACE RFA/MW

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zheng-Gang Ren

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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zheng-gang Ren, doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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liver cancer institute ,Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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LC-TACE+RFA/MV

Identifier Type: -

Identifier Source: org_study_id

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