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
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
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Shanghai
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Shanghai, Shanghai, China, 200438
- Eastern hepatobilliary surgery hospital
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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:
- 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
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 |
|---|---|
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Active Comparator: Group TACE
Patients will treated with TACE after resection.
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Patients will treated by TACE in 4 or 8 weeks after operation.
Other Names:
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No Intervention: Group Control
Patients will treated without TACE after resection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time to recurrence
Time Frame: 3 years
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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.