- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02449109
Nano Drug Interventional Therapy Using Digital Subtraction Angiography(DSA) for Liver Carcinoma
Nano Drug Interventional Therapy Using Digital Subtraction Angiography(DSA) for Liver Carcinoma:Clinical Trial
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Central laboratory in Fuda cancer hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Liver cancer patients never received any interventional therapy.
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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.
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Liver cancer patients received drug interventional therapy using the digital subtraction angiography(DSA)
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Active Comparator: Drug microspheres
Liver cancer patients received drug microspheres (HepaSphere Microspheres) interventional therapy using digital subtraction angiography(DSA).
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Liver cancer patients received drug interventional therapy using the digital subtraction angiography(DSA)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Adverse events
Time Frame: 1 year
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 1 year
|
1 year
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Percentage of lesions that show no sign of recurrence 12 months after interventional therapy
Time Frame: 1 year
|
1 year
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Progress free disease (PFS)
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nano drug liver cancer
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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