NCT02728219

Brief Summary

The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
Last Updated

April 5, 2016

Status Verified

March 1, 2016

Enrollment Period

2.5 years

First QC Date

March 28, 2016

Last Update Submit

March 30, 2016

Conditions

Recurrent Hepatocellular Carcinoma

Keywords

Recurrent Hepatocellular Carcinomatranscatheter arterial chemoembolizationAFP conversion

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Study Arms (2)

hepatectomy

EXPERIMENTAL

Comparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion

Procedure: TACE

TACE

ACTIVE COMPARATOR
Procedure: Hepatectomy

Interventions

TACEPROCEDURE

In this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE)

Also known as: transcatheter arterial chemoembolization
hepatectomy
HepatectomyPROCEDURE

Repeat Hepatectomy after postoperation recurrence

TACE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
  • age:18-70years
  • better liver function (Child-Pugh，class A or B)

You may not qualify if:

  • reject to attend；
  • impossible to come to our hospital for physical examination regularly.
  • cancer epitome、seed focus、lymph node or distant metastasis
  • Blood clotting function hindrance;
  • serious heart、lung、kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 5, 2016

Study Start

May 1, 2012

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

April 5, 2016

Record last verified: 2016-03

Locations

CN(1)