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Completed

NCT Number: NCT00479050

Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Combined the chemoembolization and Radiofrequency ablation for the hepatocellular carcinoma greater than 3 cm,the ablation volume of coagulation necrosis can be significantly increased,which may be enable effective treatment of patients with HCC greater than 3 cm.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

To assess whether the effectiveness of a combination of transcatheter arterial chemoembolization(TACE) and radiofrequency ablation(RFA) is superior to TACE and RFA alone in treatment of patients with hepatocellular carcinoma(HCC)greater than 3 cm and to analyze the factors affecting the outcomes.

The patients with HCC of 3 or fewer lesions, each 3cm greater in diameter entered this randomized controlled trial. The primary end point was survival, and the secondary end points were tumor response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Eligibility criteria were:

  • Not indicated for resection,
  • Liver function of Child-Pugh class A or B,
  • 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,
  • No portal vein involvement or extrahepatic metastasis,
  • Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,
  • Platelet count≥6.0×103/mm3 and the prothrombin activity≥60%, and
  • No previous HCC treatment.

Exclusion criteria

Exclusion criteria

were:

  • Encephalopathy,
  • Refractory ascites,
  • Active gastrointestinal bleeding,
  • Renal failure.

Treatment and study plan

chemoembolization ,Radiofrequency ablation

Procedure

Primary outcomes

  1. overall survival

    Time frame: 5 years

Secondary outcomes

  1. tumor response

    Time frame: 1-6 months

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm

Acronym: TACE-RFA

Important dates

Study start
2001
Study completion
2006
First posted
May 25, 2007
Registry last updated
May 25, 2007

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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