Combined Treatment of RFA and Sorafenib on Recurrent HCC

HCC Clinical Trial

— REPEAT  

Official title:

Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01470495
• Other study ID #: swhb005
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2011
• Last updated: March 27, 2017
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Southwest Hospital, China
• Contact: Xiaobin Feng, MD
• Phone: +86-2368765297
• Email: fengxiaobin200708[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• recurrent HCC after curative resection

• without gender restriction

• age between 18 to 75 years

• The liver function showed no worse than Child-Pugh B

• tumor nodes were less than 5cm and no more than 3 nodules

Exclusion Criteria:

• Pregnancy patients

• With extrahepatic tumor or lymphnode metastasis

• Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava

Related Conditions & MeSH terms

• HCC
• Radiofrequency Ablation
• Sorafenib

Intervention

Other:
• RFA + Sorafenib
combined RFA and Sorafenib to treat recurrent HCC
• RFA
treat Recurrent HCC with RFA

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,southwest hospital	Chongqing	Chongqing

Sponsors (14)

Lead Sponsor

Collaborator

Southwest Hospital, China

Anhui Provincial Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Henan Cancer Hospital, Huaxi Hospital, Hunan Province Tumor Hospital, People's Hospital of Guangxi, People's Hospital of Sichuan, Tang-Du Hospital, Xiangya Hospital of Central South University, Xijing Hospital, Xinjiang Tumor Hospital, Xinqiao Hospital of Chongqing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time interval between new lessions emerging after the first HCC recurrence		3 year
Secondary	3-year overrall survival		3 year