Combined Treatment of RFA and Sorafenib on Recurrent HCC (REPEAT)

March 27, 2017 updated by: feng xiaobin, Southwest Hospital, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Institute of hepatobiliary surgery,southwest hospital
        • Contact:
        • Principal Investigator:
          • feng xiaobin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA+Sorafenib
to treat recurrent HCC both with RFA and Sorafenib
Other: RFA + Sorafenib
combined RFA and Sorafenib to treat recurrent HCC
Active Comparator: RFA group
To treat recurrent HCC with RFA
Other: RFA
treat Recurrent HCC with RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time interval between new lessions emerging after the first HCC recurrence
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
3-year overrall survival
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Collaborators

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

Investigators

  • Principal Investigator: Kuansheng Ma, MD,Ph.D, Southwest Hopstial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • swhb005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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