Combined Treatment of RFA and Sorafenib on Recurrent HCC
REPEAT
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
1 other identifier
interventional
430
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 28, 2017
March 1, 2017
3.9 years
November 9, 2011
March 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
time interval between new lessions emerging after the first HCC recurrence
3 year
Secondary Outcomes (1)
3-year overrall survival
3 year
Study Arms (2)
RFA+Sorafenib
EXPERIMENTALto treat recurrent HCC both with RFA and Sorafenib
RFA group
ACTIVE COMPARATORTo treat recurrent HCC with RFA
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy patients
- With extrahepatic tumor or lymphnode metastasis
- Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Southwest Hospital, Chinalead
- Hunan Province Tumor Hospitalcollaborator
- Tang-Du Hospitalcollaborator
- Xijing Hospitalcollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
- Anhui Provincial Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Xinqiao Hospital of Chongqingcollaborator
- Xinjiang Tumor Hospitalcollaborator
- People's Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- Henan Cancer Hospitalcollaborator
- People's Hospital of Sichuancollaborator
- Huaxi Hospitalcollaborator
Study Sites (1)
Institute of hepatobiliary surgery,southwest hospital
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuansheng Ma, MD,Ph.D
Southwest Hopstial
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Institute of hepatobiliary surgery,southwest hospital
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 11, 2011
Study Start
January 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 28, 2017
Record last verified: 2017-03