p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

Phase 2

• Conditions: Diabetes; HCC
• Interventions: Drug: p53 gene therapy; Drug: Trans-catheter embolization

• Registration Number: NCT02561546
• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

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.

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-25
• Last Update Submitted: 2015-09-25
• Study First Posted: 2015-09-28
• Last Update Posted: 2015-09-28
• Study Start: 2015-12
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• histopathologically diagnosed unresectable HCC
• 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

• hypersensitive to study drug
• With an abnormal coagulation condition or bleeding disorder
• infections
• with serious conditions which prevent using the study treatment
• pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAE plus p53 gene therapy	p53 gene therapy	Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
TAE plus p53 gene therapy	Trans-catheter embolization	Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
Trans-catheter embolization	Trans-catheter embolization	Trans-catheter embolization (TAE) will be given once per month

Primary Outcome Measures

Name	Time	Method
fasting plasma glucose (FPG)	from starting treatment until 60 days	In 60 days after starting study treatment
glycosylated hemoglobin (A1C)	from starting treatment until 60 days	In 60 days after starting study treatment

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	2 years	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.
progression free survival (PFS)	2 years	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.
postprandial glucose (PPG)	from starting treatment until 60 days	from starting treatment until 60 days treatment

Trial Locations

Locations (1)

first affiliated hospital in Dalian University; 🇨🇳 Dalian, Liaoning, China