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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02724358
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma TACE Notch1 Rg3 Procedure: TACE Drug: Rg3 Other: TACE + Rg3 Procedure: protective therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: TACE
iodized oil (5ml) + Pirarubicin (20mg)
Procedure: TACE
iodized oil (5ml) + Pirarubicin (20mg)
Other Name: Transcatheter Arterial Chemoembolization

Experimental: Rg3
20mg, BID, maintained though Month 12
Drug: Rg3
20mg, BID, maintained though Month 12.

Experimental: TACE + Rg3
the combination of the treatments for the above two groups. Rg3 will be stopped on the day performing TACE.
Other: TACE + Rg3
Experimental: Control
standard liver protective therapy
Procedure: protective therapy
standard liver protective therapy




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
  2. Time to progression [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no pathological evidence of HCC


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724358


Locations
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China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital

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Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT02724358    
Other Study ID Numbers: 2012ZX10002016008
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
Carcinoma
Hepatocellular
Notch1
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Chlorotrianisene
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents