Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
45 Years
75 Years
Both
Hepatocellular Carcinoma
Trial Information
Phase 1 Study of Combination Chemoembolization and Radiofrequency Ablation for Hepatocellular Carcinoma Greater Than 3 cm
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
5 years
Principal Investigator
Wang Qi Liang, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Dept. of Radiology
Authority:
China: Ethics Committee
Study ID:
2001HCC
NCT ID:
NCT00479050
Start Date:
January 2001
Completion Date:
December 2006
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular carcinoma,treatment
- Carcinoma
- Carcinoma, Hepatocellular
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