Spots Global Cancer Trial Database for p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
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Trial Identification
Brief Title: p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Official Title: A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Study ID: NCT02561546
Study Description
Brief Summary: An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).
Detailed Description: It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
first affiliated hospital in Dalian University, Dalian, Liaoning, China
Contact Details
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