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

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

Anti-recurrence Treatment of Postresection on Hepatocellular Carcinoma Patients With Microvascular Invasion Presence and Over-expression of Aspartate Beta-hydroxylase: A Randomized Controlled Study

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group TACE
Patients will treated with TACE after resection.
Procedure: TACE
Patients will treated by TACE in 4 or 8 weeks after operation.
Other Names:
  • Transhepatic Arterial Chemotherapy And Embolization
No Intervention: Group Control
Patients will treated without TACE after resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2015-01-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on TACE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe