Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma
February 23, 2016 updated by: Fuda Cancer Hospital, Guangzhou
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma：Clinical Trial
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.
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
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
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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 |
|---|---|
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Number of participants with Adverse events
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Overall survival (OS)
Time Frame: 1 year
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1 year
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Percentage of lesions that show no sign of recurrence 12 months after interventional therapy
Time Frame: 1 year
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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
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
May 14, 2015
First Submitted That Met QC Criteria
May 15, 2015
First Posted (Estimate)
May 20, 2015
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
June 1, 2015
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.