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

Clinical Trial of Transcatheter Arterial Chemoembolization Combined With Radiofrequency/Microwave Ablation in Hepatocellular Carcinoma Beyond Milan Criterial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03636620

Acronym

TACE+RFA

Enrollment

110

Registered

2018-08-17

Start date

2013-06-30

Completion date

2018-08-31

Last updated

2018-08-17

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

Conditions

Hepatocellular Carcinoma

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.

Interventions

DEVICETranscatheter arterial chemoembolization

Transcatheter arterial chemoembolization

DEVICEradiofrequency ablation/microwave ablation

radiofrequency ablation/microwave ablation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

TACE vs.TACE+RFA

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
overall survival	up to 46 months

Secondary

Measure	Time frame
objective response rate	up to 46 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026