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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TACE
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Recurrence, Microvascular Invasion, Aspartate beta-hydroxylase

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group TACE

Group Control

Arm Description

Patients will treated with TACE after resection.

Patients will treated without TACE after resection.

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time to recurrence

Full Information

First Posted
October 26, 2015
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02587884
Brief Title
Anti-recurrence Treatment of Postresection on HCC Patients With MVI Presence and Over-expression of ASPH
Official Title
Anti-recurrence Treatment of Postresection on Hepatocellular Carcinoma Patients With Microvascular Invasion Presence and Over-expression of Aspartate Beta-hydroxylase: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Recurrence, Microvascular Invasion, Aspartate beta-hydroxylase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group TACE
Arm Type
Active Comparator
Arm Description
Patients will treated with TACE after resection.
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
Patients will treated without TACE after resection.
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transhepatic Arterial Chemotherapy And Embolization
Intervention Description
Patients will treated by TACE in 4 or 8 weeks after operation.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Time to recurrence
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Kui, MD
Phone
86-021-81875242
Email
wangkuiykl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD
Phone
0086-021-25070805
Email
shenfengdfgd@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yong Xia, Doctor
Phone
86-021-81875495

12. IPD Sharing Statement

Learn more about this trial

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

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