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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00479050
Acronym
TACE-RFA
Enrollment
291
Registered
2007-05-25
Start date
2001-01-31
Completion date
2006-12-31
Last updated
2007-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma,treatment

Brief 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.

Detailed 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.

Interventions

PROCEDUREchemoembolization ,Radiofrequency ablation

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
overall survival5 years

Secondary

MeasureTime frame
tumor response1-6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026