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

Naval Military Medical University (Second Military Medical University)

Status: Completed

Conditions: Hepatocellular Carcinoma; TACE; Rg3; Notch1

Treatments: Procedure: TACE; Other: TACE + Rg3; Procedure: protective therapy; Drug: Rg3

Study type: Interventional

Funder types: Other

Identifiers

NCT02724358

2012ZX10002016008

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

no pathological evidence of HCC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 4 patient groups

TACE

Experimental group

Description:

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

Treatment:

Procedure: TACE

Rg3

Experimental group

Description:

20mg, BID, maintained though Month 12

Treatment:

Drug: Rg3

TACE + Rg3

Experimental group

Description:

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

Treatment:

Other: TACE + Rg3

Control

Experimental group

Description:

standard liver protective therapy

Treatment:

Procedure: protective therapy