NCT02724358

Brief Summary

In order to provide a new option for clinical anti-angiogenesis therapy in hepatoma, a randomized controlled study is planed to confirm the effect of Rg3 in combination with TACE on angiogenesis and tumor treatment in advanced hepatocellular carcinoma patients with high expression of Notch1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years 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

1 year

First QC Date

March 28, 2016

Last Update Submit

March 28, 2016

Conditions

Hepatocellular CarcinomaTACENotch1Rg3

Keywords

CarcinomaHepatocellularNotch1

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    3 years

  • Time to progression

    3 years

Study Arms (4)

TACE

EXPERIMENTAL

iodized oil (5ml) + Pirarubicin (20mg)

Procedure: TACE

Rg3

EXPERIMENTAL

20mg, BID, maintained though Month 12

Drug: Rg3

TACE + Rg3

EXPERIMENTAL

the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE.

Other: TACE + Rg3

Control

EXPERIMENTAL

standard liver protective therapy

Procedure: protective therapy

Interventions

TACEPROCEDURE

iodized oil (5ml) + Pirarubicin (20mg)

Also known as: Transcatheter Arterial Chemoembolization
TACE
Rg3DRUG

20mg, BID, maintained though Month 12.

Rg3
TACE + Rg3OTHER
TACE + Rg3
protective therapyPROCEDURE

standard liver protective therapy

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed hepatocellular carcinoma.
  • High expression of Notch1 in tumor tissues.

You may not qualify if:

  • no pathological evidence of HCC

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, HepatocellularBicuspid Aortic Valve DiseaseCarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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 Hospital

Study Record Dates

First Submitted

March 28, 2016

First Posted

March 31, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)