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

Hepatocellular Carcinoma Clinical Trial

— TACE-RFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479050
• Other study ID #: 2001HCC
• Secondary ID: 03BS035
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2007
• Last updated: May 24, 2007
• Start date: January 2001
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

Eligibility criteria were:

1. Not indicated for resection,

2. Liver function of Child-Pugh class A or B,

3. 3 or fewer lesion, each 3 cm greater and 7.5 cm less in greatest diameter,

4. No portal vein involvement or extrahepatic metastasis,

5. Lesions located at least 5mm away from the hepatic hilum or gall bladder and the common bile duct,

6. Platelet count=6.0×103/mm3 and the prothrombin activity=60%, and

7. No previous HCC treatment.

Exclusion Criteria:

Exclusion criteria were:

1. Encephalopathy,

2. Refractory ascites,

3. Active gastrointestinal bleeding,

4. Renal failure.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• chemoembolization ,Radiofrequency ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 years
Secondary	tumor response		1-6 months