NCT02587884

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).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

First QC Date

October 26, 2015

Last Update Submit

March 30, 2016

Conditions

Hepatocellular Carcinoma

Keywords

RecurrenceMicrovascular InvasionAspartate beta-hydroxylase

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    3 years

Secondary Outcomes (1)

  • Time to recurrence

    3 years

Study Arms (2)

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

TACEPROCEDURE

Patients will treated by TACE in 4 or 8 weeks after operation.

Also known as: Transhepatic Arterial Chemotherapy And Embolization
Group TACE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Shen Feng, MD

    Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Kui, MD

CONTACT

86-021-81875242wangkuiykl@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospital Affiliation: Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)