NCT02561546

p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCC
• Diabetes

Interventions

Type	Name	Description
DRUG	p53 gene therapy	Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
DRUG	Trans-catheter embolization	Trans-catheter embolization alone

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-09-28
• Last updated: 2015-09-28

Locations

1 site across 1 country: China