Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma
NCT ID: NCT02509169
Last Updated: 2015-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2014-10-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAE plus p53 gene
Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
TAE plus P53 gene
Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
TAE
Trans-catheter embolization (TAE) will be given once per month
TAE
Trans-catheter embolization
Interventions
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TAE plus P53 gene
Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
TAE
Trans-catheter embolization
Eligibility Criteria
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Inclusion Criteria
* over 18 years old
* with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
* with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
* with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
* signed the informed consent form.
Exclusion Criteria
* With an abnormal coagulation condition or bleeding disorder
* infections
* with serious conditions which prevent using the study treatment
* pregnant or lactating
18 Years
85 Years
ALL
No
Sponsors
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Shenzhen SiBiono GeneTech Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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first affiliated hospital in Dalian University
Dalian, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TCAp53-110
Identifier Type: -
Identifier Source: org_study_id
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