Status:

UNKNOWN

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma

Lead Sponsor:

Sun Yat-sen University

Conditions:

Hepatocellular Carcinoma

RFA

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better efficacy than RF...

Detailed Description

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial hepatectomy and liver transplantation are considered to be standard curative therapies for HCC. When surgery is not...

Eligibility Criteria

Inclusion

  • age 18 - 75 years;
  • Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy);
  • no other treatment received except for the initial RFA or hepatectomy;
  • Single tumor less than 4cm in diameter;
  • lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
  • no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3;
  • Eastern Co-operative Oncology Group performance(ECOG) status 0 -

Exclusion

  • the presence of vascular invasion or extrahepatic spread on imaging;
  • a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
  • an American Society of Anesthesiologists (ASA) score ≥ 3

Key Trial Info

Start Date :

February 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2014

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT01415063

Start Date

February 1 2011

End Date

March 1 2014

Last Update

August 11 2011

Active Locations (1)

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1

Cancer Center, Sun Yat-set University

Guangzhou, Guangdong, China, 510060