Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma

Sponsor

Fuda Cancer Hospital, Guangzhou (Other)

Overall Status

Completed

CT.gov ID

NCT02449109

Collaborator

(none)

Enrollment

Location

Arms

9.1

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of nano drug（Gemzar® mix with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction angiography（DSA） for liver cancer.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer	Procedure: interventional therapy	Phase 1/Phase 2

Detailed Description

By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for liver cancer.

The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's size is detected by laser diffraction particle size analyzer.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma：Clinical Trial

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Liver cancer patients never received any interventional therapy.
Experimental: Nano drug Liver cancer patients received nano drug interventional therapy using digital subtraction angiography（DSA）. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.	Procedure: interventional therapy Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）
Active Comparator: Drug microspheres Liver cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography（DSA）.	Procedure: interventional therapy Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）

Arm

Intervention/Treatment

No Intervention: Control

Liver cancer patients never received any interventional therapy.

Experimental: Nano drug

Liver cancer patients received nano drug interventional therapy using digital subtraction angiography（DSA）. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

Procedure: interventional therapy

Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）

Active Comparator: Drug microspheres

Liver cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography（DSA）.

Procedure: interventional therapy

Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse events [1 year]

Secondary Outcome Measures

Percentage of lesions that show no sign of recurrence 12 months after interventional therapy [1 year]
Progress free disease (PFS) [1 year]
Overall survival (OS) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age:18-80
Karnofsky performance status >60
Diagnosis of liver cancer based on histology or the current accepted radiological measures.
Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
Will receive interventional therapy
Life expectancy: Greater than 3 months
Patients' routine blood test, liver function and kidney function have no obvious abnormalities
Ability to understand the study protocol and a willingness to sign a written informed consent document