NCT02724332

Brief Summary

To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Nov 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

March 28, 2016

Last Update Submit

March 28, 2016

Conditions

Hepatocellular CarcinomaRapamycin

Keywords

Aspartate beta hydroxylasetranscatheter arterial chemoembolization

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    3 years

Secondary Outcomes (1)

  • Time to recurrence

    3 years

Study Arms (2)

control group

NO INTERVENTION

Patients will be treated with radical hepatectomy only.

transcatheter arterial chemoembolization

ACTIVE COMPARATOR

Patients will be treated with TACE

Drug: Rapamycin

Interventions

RapamycinDRUG

2mg,po,bid

transcatheter arterial chemoembolization

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 primary liver cancer
  • Pathological evidence of HCC
  • Estimate tumor can gain treatment of curing operation
  • No evidence for extrahepatic metestasis
  • liver function ：Child-Pugh A/B
  • BCLC stage：0/1；TNM stage：Ⅰ

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; 5, Patients with other diseases which may affect the treatment mentioned.

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

Sirolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
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 Hospital

Study Record Dates

First Submitted

March 28, 2016

First Posted

March 31, 2016

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)