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

Last updated: August 15, 2018
Sponsor: Fudan University
Overall Status: Completed

Phase

3

Condition

Carcinoma

Liver Disease

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT03636620
LC-TACE+RFA/MV
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ≤

  1. 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

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 herbalmedicine ) ;

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

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

Study Design

Total Participants: 110
Study Start date:
June 01, 2013
Estimated Completion Date:
August 31, 2018

Study 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.

Connect with a study center

  • liver cancer institute ,Fudan University

    Shanghai, 200032
    China

    Site Not Available

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