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

NCT ID: NCT02587884

Last Updated: 2016-03-31

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

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Keywords

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Recurrence Microvascular Invasion Aspartate beta-hydroxylase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group TACE

Patients will treated with TACE after resection.

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

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

Group Control

Patients will treated without TACE after resection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TACE

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

Intervention Type PROCEDURE

Other Intervention Names

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Transhepatic Arterial Chemotherapy And Embolization

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Reject to attend
2. Impossible to come to our hospital for physical examination regularly
3. Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction
4. Female with pregnancy or during the lactation period
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital Affiliation: Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shen Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Locations

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Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Wang Kui, MD

Role: CONTACT

Phone: 86-021-81875242

Email: [email protected]

Facility Contacts

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Feng Shen, MD

Role: primary

Yong Xia, Doctor

Role: backup

Other Identifiers

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EHBHKY2015-01-024

Identifier Type: -

Identifier Source: org_study_id