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

Liver Cancer Institiute ,Fudan University

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03642561
Enrollment
300
Registered
2018-08-22
Start date
2019-09-03
Completion date
2022-08-01
Last updated
2020-07-28

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

Conditions

Hepatocellular Carcinoma

Brief summary

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

Detailed 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.

Interventions

DEVICEradiotherapy ablation

We using Cool Tip system or RITA system to perform RFA

DEVICEtransarterial chemoembolization(TACE)

TACE treatment is a first line treatment for BCLC stage B HCC

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

group 1 RFA alone group 2 TACE alone

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
overall survivalup to 60 months

Secondary

MeasureTime frame
objective response rateup to 60 months

Countries

China

Contacts

Primary ContactXin Yin, doctor
yin.xin@zs-hospital.sh.cn+86-21-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026