search
Back to results

Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1

Primary Purpose

Hepatocellular Carcinoma, TACE, Notch1

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE
Rg3
TACE + Rg3
protective therapy
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 Carcinoma, Hepatocellular, Notch1

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

no pathological evidence of HCC

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

TACE

Rg3

TACE + Rg3

Control

Arm Description

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

20mg, BID, maintained though Month 12

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

standard liver protective therapy

Outcomes

Primary Outcome Measures

Overall Survival
Time to progression

Secondary Outcome Measures

Full Information

First Posted
March 28, 2016
Last Updated
March 28, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02724358
Brief Title
Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, TACE, Notch1, Rg3
Keywords
Carcinoma, Hepatocellular, Notch1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACE
Arm Type
Experimental
Arm Description
iodized oil (5ml) + Pirarubicin (20mg)
Arm Title
Rg3
Arm Type
Experimental
Arm Description
20mg, BID, maintained though Month 12
Arm Title
TACE + Rg3
Arm Type
Experimental
Arm Description
the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE.
Arm Title
Control
Arm Type
Experimental
Arm Description
standard liver protective therapy
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter Arterial Chemoembolization
Intervention Description
iodized oil (5ml) + Pirarubicin (20mg)
Intervention Type
Drug
Intervention Name(s)
Rg3
Intervention Description
20mg, BID, maintained though Month 12.
Intervention Type
Other
Intervention Name(s)
TACE + Rg3
Intervention Type
Procedure
Intervention Name(s)
protective therapy
Intervention Description
standard liver protective therapy
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
Time to progression
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed hepatocellular carcinoma. High expression of Notch1 in tumor tissues. Exclusion Criteria: no pathological evidence of HCC
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

Learn more about this trial

Rg3 in Combination With TACE in Hepatocellular Carcinoma Patients With High Expression of Notch1

We'll reach out to this number within 24 hrs