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

Not Applicable

Completed

• Conditions: Notch1; Rg3; Hepatocellular Carcinoma; TACE
• Interventions: Drug: Rg3; Procedure: protective therapy; Other: TACE + Rg3; Procedure: TACE

• Registration Number: NCT02724358
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-28
• Last Update Submitted: 2016-03-28
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

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

Exclusion Criteria

no pathological evidence of HCC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rg3	Rg3	20mg, BID, maintained though Month 12
Control	protective therapy	standard liver protective therapy
TACE + Rg3	TACE + Rg3	the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE.
TACE	TACE	iodized oil (5ml) + Pirarubicin (20mg)

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 years
Time to progression	3 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China