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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: interventional therapy


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Patients with other primary tumor except liver cancer History of coagulation disorders or anemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Liver cancer patients never received any interventional therapy. | |
| Experimental: Nano drug<br>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<br>* Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）<br>|
| Active Comparator: Drug microspheres<br>Liver cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography（DSA）. | Procedure: interventional therapy<br>* Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Cancer, Nano drug