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Clinical Trial Details

Trial ID: L5895
Source ID: NCT02561546
Associated Drug: P53 Gene Therapy
Title: p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: HCC|Diabetes
Interventions: DRUG: p53 gene therapy|DRUG: Trans-catheter embolization
Outcome Measures: Primary: fasting plasma glucose (FPG), In 60 days after starting study treatment, from starting treatment until 60 days|glycosylated hemoglobin (A1C), In 60 days after starting study treatment, from starting treatment until 60 days | Secondary: overall survival (OS), overall survival will be follow up to 2 years. Time to an event (death), or censored status (lost of follow up, withdrawal from the study, or still alive on 2 years) will be recorded. OS will be estimated using Kaplan-Meier method., 2 years|progression free survival (PFS), PFS will be follow up to 2 years. Time to an event (progression or death) or censored status (lost of follow up, withdrawal from the study, or still alive and no progression on 2 years). Assessment of progression will follow RECIST standard Version 1.1. PFS will be estimated using Kaplan-Meier method., 2 years|postprandial glucose (PPG), from starting treatment until 60 days treatment, from starting treatment until 60 days
Sponsor/Collaborators: Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-12
Completion Date: 2017-12
Results First Posted:
Last Update Posted: 2015-09-28
Locations: first affiliated hospital in Dalian University, Dalian, Liaoning, China
URL: https://clinicaltrials.gov/show/NCT02561546