Anti-recurrence Treatment of Postresection on HCC Patient... | NCT02587884

Studies
Anti-recurrence Treatment of Postresection on HCC Patients With MVI Presence and Over-expression of ASPH

NCT02587884

Sponsor

Eastern Hepatobiliary Surgery Hospital

Status

Unknown status

Last Update Posted

Mar 31, 2016Estimated

Enrollment

180Estimated

Phase

Phase 1

Conditions

Hepatocellular Carcinoma

Interventions

TACE

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 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Oct 26, 2015

First Submission Date that Met QC Criteria

Oct 26, 2015

First Posted Date

Oct 27, 2015Estimated

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 30, 2016

Last Update Posted Date

Mar 31, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital Affiliation: Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery HospitalPrincipal Investigator

Lead Sponsor

Eastern Hepatobiliary Surgery HospitalOTHER

Collaborators

Not provided

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

The aim of this study is to explore the effect of Transarterial Chemoembolization (TACE) on the prognosis of patients with microvascular invasion presence(MVI) and overexpression of Aspartate-β-hydroxylase(ASPH).

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group TACE	Active Comparator	Patients will treated with TACE after resection.	Procedure: TACE
Group Control	No Intervention	Patients will treated without TACE after resection.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TACE	Procedure	Patients will treated by TACE in 4 or 8 weeks after operation.	Group TACE

Measure	Description	Time Frame
Overall Survival		3 years

Measure	Description	Time Frame
Time to recurrence		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Via clinical diagnosis and confirm it is primary liver cancer
Pathological evidence of HCC
Confirm presence of MVI and over-expression of ASPH after opreation
Within Milan criteria
Estimate tumor can gain treatment of curing operation
No evidence for extrahepatic metestasis
liver function ：Child-Pugh A/B

Exclusion Criteria:

Reject to attend
Impossible to come to our hospital for physical examination regularly
Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction
Female with pregnancy or during the lactation period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang Kui, MD	Contact	86-021-81875242		wangkuiykl@163.com

Overall Officials

Name	Affiliation	Role
Shen Feng, MD	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern hepatobilliary surgery hospital		Shanghai	Shanghai Municipality	200438	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D012008	Recurrence

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004621	Embolization, Therapeutic

Ancestor Terms

ID	Term
D006489	Hemostatic Techniques
D013812	Therapeutics
D060205	Therapeutic Occlusion

Browse Leaves

Not provided

Browse Branches

Not provided