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

NCT ID: NCT02724358

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma TACE Notch1 Rg3

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Carcinoma Hepatocellular Notch1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TACE

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

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

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

Rg3

20mg, BID, maintained though Month 12

Group Type EXPERIMENTAL

Rg3

Intervention Type DRUG

20mg, BID, maintained though Month 12.

TACE + Rg3

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

Group Type EXPERIMENTAL

TACE + Rg3

Intervention Type OTHER

Control

standard liver protective therapy

Group Type EXPERIMENTAL

protective therapy

Intervention Type PROCEDURE

standard liver protective therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TACE

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

Intervention Type PROCEDURE

Rg3

20mg, BID, maintained though Month 12.

Intervention Type DRUG

TACE + Rg3

Intervention Type OTHER

protective therapy

standard liver protective therapy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Transcatheter Arterial Chemoembolization

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

no pathological evidence of HCC
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012ZX10002016008

Identifier Type: -

Identifier Source: org_study_id