TACE Combined With RFA/MV Treatment in Hepatocellular Carcinoma Beyond Milan Criterial (TACE+RFA)

Fudan University

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Device: radiofrequency ablation/microwave ablation; Device: Transcatheter arterial chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03636620

LC-TACE+RFA/MV

Details and patient eligibility

About

This study was designed to evaluate the effectiveness of radiofrequency /microwave ablation in patients with hepatocellular carcinoma beyond Milan Criteria.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

TACE group

Active Comparator group

Description:

Transcatheter arterial chemoembolization

Treatment:

Device: Transcatheter arterial chemoembolization

TACE+RFA/MV group

Experimental group

Description:

Transcatheter arterial chemoembolization and radiofrequency /microwave ablation

Treatment:

Device: Transcatheter arterial chemoembolization

Device: radiofrequency ablation/microwave ablation