Combined Treatment of RFA and Sorafenib on Recurrent HCC

NCT ID: NCT01470495

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HCC Radiofrequency Ablation Sorafenib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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RFA+Sorafenib

to treat recurrent HCC both with RFA and Sorafenib

Group Type EXPERIMENTAL

RFA + Sorafenib

Intervention Type OTHER

combined RFA and Sorafenib to treat recurrent HCC

RFA group

To treat recurrent HCC with RFA

Group Type ACTIVE_COMPARATOR

RFA

Intervention Type OTHER

treat Recurrent HCC with RFA

Interventions

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RFA + Sorafenib

combined RFA and Sorafenib to treat recurrent HCC

Intervention Type OTHER

RFA

treat Recurrent HCC with RFA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role collaborator

Xinjiang Tumor Hospital

UNKNOWN

Sponsor Role collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

People's Hospital of Sichuan

UNKNOWN

Sponsor Role collaborator

Huaxi Hospital

OTHER

Sponsor Role collaborator

Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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feng xiaobin

Institute of hepatobiliary surgery,southwest hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuansheng Ma, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Southwest Hopstial

Locations

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Institute of hepatobiliary surgery,southwest hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaobin Feng, MD

Role: CONTACT

+86-2368765297

Facility Contacts

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feng xiaobin, MD

Role: primary

+86-23-13228683243

Other Identifiers

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swhb005

Identifier Type: -

Identifier Source: org_study_id

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