Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
Brief Summary
This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.
Detailed Description
The aim of this study is to included 120 patients with intermediate stage hepatocellular carcinoma beyond Milan criteria .These patients were randomizedly allocated to TACE treatment group or TACE+RFA/MV .The treatment effectiveness, local tumor control and survival outcome between the two groups were compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients diganosed with hepatocellualr carcinoma beyond Milan criteria
- •the presence of a single HCC tumor ≤7 cm in diameter, or multi-nodular HCC tumors (n ≤ 5) small than 7 cm in diameter;
- •Child-Pugh A or B
- •ECOG score 0-1;
- •prothrombin time ≤16 s;
- •white cell count ≥3,000/mm3, platelet count ≥40 x 109/L;Hb≥8.5 g/d; ALT/AST≤5×ULN;TB≤3mg/dl;alb≥2.8 g/dl ;Scr ≤2mg/dl
Exclusion Criteria
- •expected survival time < 12 months before random assignment;
- •received anticancer surgery or procedure within one month before assignment;
- •concomitant use of any other anticancer therapy(except immunotherapy and herbal medicine ) ;
- •existence of portal of hepatic vein invation or extrahepatic metastases;existence of active infection ;
- •upper gastrointestinal hemorrhage within one month ; .other serious illness or medical condition.
Arms & Interventions
TACE group
Transcatheter arterial chemoembolization
Intervention: Transcatheter arterial chemoembolization (Device)
TACE+RFA/MV group
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
Intervention: Transcatheter arterial chemoembolization (Device)
TACE+RFA/MV group
Transcatheter arterial chemoembolization and radiofrequency /microwave ablation
Intervention: radiofrequency ablation/microwave ablation (Device)
Outcomes
Primary Outcomes
overall survival
Time Frame: up to 46 months
Secondary Outcomes
- objective response rate(up to 46 months)
Investigators
Zheng-Gang Ren
professor
Fudan University