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Completed

NCT Number: NCT03636620

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

liver cancer institute ,Fudan University

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter arterial chemoembolization

Device

Transcatheter arterial chemoembolization

Other names: TACE

radiofrequency ablation/microwave ablation

Device

radiofrequency ablation/microwave ablation

Other names: RFA/MW

Primary outcomes

  1. overall survival

    Time frame: up to 46 months

Secondary outcomes

  1. objective response rate

    Time frame: up to 46 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: TACE+RFA

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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