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

Hepatocellular Carcinoma Clinical Trial

Official title:

Liver Cancer Institiute ,Fudan University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642561
• Other study ID #: LC-RFA vs.TACE
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 3, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: July 2020
• Source: Fudan University
• Contact: Xin Yin, doctor
• Phone: +86-21-64041990
• Email: yin.xin[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• radiotherapy ablation
We using Cool Tip system or RITA system to perform RFA
• transarterial chemoembolization(TACE)
TACE treatment is a first line treatment for BCLC stage B HCC

Locations

Country	Name	City	State
China	Zhongshan hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		up to 60 months
Secondary	objective response rate		up to 60 months