Combined Treatment of RFA and Sorafenib on Recurrent HCC | NCT01470495

Studies
Combined Treatment of RFA and Sorafenib on Recurrent HCC

NCT01470495

Sponsor

Southwest Hospital, China

Status

Unknown status

Last Update Posted

Mar 28, 2017Actual

Enrollment

430Estimated

Phase

Not Applicable

Conditions

HCC
Radiofrequency Ablation
Sorafenib

Interventions

RFA + Sorafenib
RFA

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Nov 9, 2011

First Submission Date that Met QC Criteria

Nov 10, 2011

First Posted Date

Nov 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2017

Last Update Posted Date

Mar 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

feng xiaobin, Institute of hepatobiliary surgery,southwest hospital, Southwest Hospital, ChinaPrincipal Investigator

Lead Sponsor

Southwest Hospital, ChinaOTHER

Collaborators

Name	Class
Hunan Province Tumor Hospital	OTHER
Tang-Du Hospital	OTHER
Xijing Hospital	OTHER
First Affiliated Hospital of Guangxi Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

430Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RFA+Sorafenib	Experimental	to treat recurrent HCC both with RFA and Sorafenib	Other: RFA + Sorafenib
RFA group	Active Comparator	To treat recurrent HCC with RFA	Other: RFA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RFA + Sorafenib	Other	combined RFA and Sorafenib to treat recurrent HCC	RFA+Sorafenib

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
3-year overrall survival		3 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaobin Feng, MD	Contact	+86-2368765297		fengxiaobin200708@aliyun.com

Overall Officials

Name	Affiliation	Role
Kuansheng Ma, MD,Ph.D	Southwest Hopstial	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of hepatobiliary surgery,southwest hospital	Recruiting	Chongqing	Chongqing Municipality	400038	China

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation
D000077157	Sorafenib

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided