Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Fudan University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Device: transarterial chemoembolization(TACE); Device: radiotherapy ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03642561

LC-RFA vs.TACE

Details and patient eligibility

About

Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE

Full description

The investigators conduct this clinical trial to evaluate the treatment outcome of RFA in HCC patients with tumor smaller than 7cm and tumor number less than five ,in comparison with TACE treatment.The primary outcome is overall survival.The secondary outcome is objective response rate.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• age 18 to 75 years ;
• HCC confirmed by pathological or clinical diagnosis according to the American Association for the Study of Liver Diseases criteria ;
• solitary HCC less than 7cm in diameter or multiple HCC lesions less 5
• the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases;
• lesions visible on ultrasound with a safe path between the lesion and skin;
• an Eastern Cooperative Oncology Group performance status of 0-1;
• Child-Pugh class A or B cirrhosis.

The exclusion criteria :

• received any other previous treatment for HCC;
• severe coagulation disorders;
• evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding;
• presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ;
• currently had other malignancies in addition to HCC.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

RFA group

Experimental group

Description:

Patients in RFA group will accept RFA treatment

Treatment:

Device: radiotherapy ablation

TACE group

Active Comparator group

Description:

Patients in TACE group will accept TACE treatment

Treatment:

Device: transarterial chemoembolization(TACE)