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Status unknownNCT02587884Updated Mar 31, 2016

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

A Phase 1 interventional study of TACE in Hepatocellular Carcinoma, sponsored by Eastern Hepatobiliary Surgery Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Recurrence
  • Microvascular Invasion
  • Aspartate beta-hydroxylase
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 180 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    Group TACE

    Patients will treated with TACE after resection.

    Procedure: TACE

  • No intervention
    Group Control

    Patients will treated without TACE after resection.

Interventions

  • ProcedureTACE

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

    Also known as: Transhepatic Arterial Chemotherapy And Embolization

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: 3 years

Secondary outcomes

  1. Time to recurrence

    Time frame: 3 years

07

Study locations

1 site
  • Eastern hepatobilliary surgery hospital
    Shanghai, Shanghai 200438, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02587884
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Responsible party
ShenFeng (vice president of the Eastern Hepatobiliary Surgery Hospital Affiliation: Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
Oct 27, 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Mar 31, 2016

Study contacts

Wang Kui, MD
Contact
wangkuiykl@163.com
86-021-81875242
Shen Feng, MD
principal investigator · Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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